Amsc 23 001 Working Draft Amsc Roadmap v3

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WORKING DRAFT
Standardization Roadmap for Additive Manufacturing, Version 3.0
By the
America Makes & ANSI Additive Manufacturing Standardization

Collaborative (AMSC)
DRAFT America Makes & ANSI AMSC Standardization Roadmap for Additive Manufacturing – v3 Page 1 of 375
©2023 American National Standards Institute (ANSI)/National Center for Defense Manufacturing and
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1 Table of Contents
2 Table of Contents ...............................................................................................................................3
3 Acknowledgments ........................................................................................................................... 10
4 Executive Summary.......................................................................................................................... 11
5 Highlights of Roadmap Version 3.0 ................................................................................................... 13
6 1. Introduction .................................................................................................................... 21
7 1.1 Background on the AMSC and Catalyst for this Roadmap ................................................. 21
8 1.2 Roadmap Goals, Boundaries, and Target Audience........................................................... 23
9 1.3 Roadmap Structure ......................................................................................................... 23
10 1.4 List of Organizations Covered in this Roadmap ................................................................. 25
11 2. Gap Analysis of Standards and Specifications ................................................................... 29
12 2.1 Design ............................................................................................................................ 29
13 2.1.1 Introduction .................................................................................................................... 29
14 2.1.2 Design Guides ................................................................................................................. 29
15 2.1.2.1 General Guides for AM ................................................................................................. 30
16 2.1.2.2 Process-Specific Guides for AM ..................................................................................... 32
17 2.1.2.3 Design Guides for Specific Applications ......................................................................... 34
18 2.1.2.4 Machine Customizable/Adaptive Guides for AM ............................................................ 36
19 2.1.2.5 Design Guide for Post-processing .................................................................................. 37
20 2.1.2.6 Design of Lattice Structures ........................................................................................... 40
21 2.1.2.7 Design of Test Coupons ................................................................................................. 43
22 2.1.3 Design Tools.................................................................................................................... 45
23 2.1.3.1 A Machine Input and Capability Report ......................................................................... 45
24 2.1.3.2 A Requirement for an AM Simulation Benchmark Model/Part ....................................... 47
25 2.1.3.3 Standardized Design for Additive Manufacturing (DFAM) Process Chain ......................... 49
26 2.1.4 Design for Specific Applications ....................................................................................... 52
27 2.1.4.1 Design for As-built Assembly ......................................................................................... 52
28 2.1.4.2 Design for Printed Electronics ....................................................................................... 54
29 2.1.4.3 Design for Medical ........................................................................................................ 55
30 2.1.5 Design Documentation .................................................................................................... 59
31 2.1.5.1 Data Package Content ................................................................................................... 60
32 2.1.5.2 New Dimensioning and Tolerancing Requirements ........................................................ 64
33 2.1.5.3 An Organization Schema Requirement and Design Configuration Control ....................... 66
34 2.1.5.4 A Neutral Build File Format ........................................................................................... 67
35 2.1.5.5 New Terminology in Design Documentation .................................................................. 70
DRAFT America Makes & ANSI AMSC Standardization Roadmap for Additive Manufacturing – v3 Page 3 of 375LIN
1 2.1.5.6 In-Process Monitoring ................................................................................................... 71
2 2.1.5.7 Documentation of New Functional Features and Surface Features ................................. 72
3 2.1.5.8 An Acquisition Specification .......................................................................................... 75
4 2.1.6 Design Verification and Validation ................................................................................... 76
5 2.1.7 Design for Anti-counterfeiting ......................................................................................... 79
6 2.2 Process and Materials ..................................................................................................... 84
7 2.2.1 Precursor Materials ......................................................................................................... 84
8 2.2.1.1 Introduction ................................................................................................................. 84
9 2.2.1.2 Storage, Handling, and Transportation (metals, polymers) ............................................. 87
10 2.2.1.2.1. Environmental Conditions: Effects on Materials .................................................. 91
11 2.2.1.3 Characterization of Powders ......................................................................................... 93
12 2.2.1.3.1 Chemical Composition (metals, polymers, ceramics) ............................................ 93
13 2.2.1.3.2 Flowability ......................................................................................................... 98
14 2.2.1.3.3 Spreadability .................................................................................................... 100
15 2.2.1.3.4 Density (Apparent vs. Tapped) .......................................................................... 102
16 2.2.1.3.5 Particle Size and Particle Size Distribution ......................................................... 102
17 2.2.1.3.6 Particle Morphology ......................................................................................... 105
18 2.2.1.3.7 Feedstock Sampling .......................................................................................... 107
19 2.2.1.3.8 Hollow Particles and Hollow Particles with Entrapped Gas ................................. 109
20 2.2.1.3.9 Metal Powder Specifications for Procurement Activities in Support of AM ......... 111
21 2.2.1.4 Precursor Material Handling: Use, Reuse, Mixing, and Recycling Feedstock .................. 114
22 2.2.1.4.1 Terminology Related to Reuse of Feedstock Materials ....................................... 116
23 2.2.1.5 Characterization of Material Extrusion Feedstock (Filaments & Pellets) ........................ 117
24 2.2.1.5.1 Chemical Composition ...................................................................................... 117
25 2.2.1.5.2 Geometry ......................................................................................................... 118
26 2.2.1.5.3 Melt Flow ......................................................................................................... 118
27 2.2.1.5.4 Moisture Content ............................................................................................. 120
28 2.2.1.5.5 Thermal Stability .............................................................................................. 120
29 2.2.1.6 Characterization of Liquid Feedstock ........................................................................... 120
30 2.2.1.6.1 Chemical Composition ...................................................................................... 120
31 2.2.1.6.2 Viscosity ........................................................................................................... 121
32 2.2.1.6.3 Feedstock Sampling .......................................................................................... 121
33 2.2.2 Process Control ............................................................................................................. 123
34 2.2.2.1 Introduction ............................................................................................................... 123
35 2.2.2.2 Digital Format and Digital System Control ................................................................... 124
1 2.2.2.3 Machine Calibration and Preventative Maintenance .................................................... 126
2 2.2.2.4 Machine Qualification ................................................................................................. 130
3 2.2.2.5 Parameter Control ...................................................................................................... 133
4 2.2.2.6 Adverse Machine Environmental Conditions: Effect on Component Quality ................. 135
5 2.2.2.7 Stratification............................................................................................................... 136
6 2.2.2.8 Powder Blending and Powder Mixing Terminology ...................................................... 138
7 2.2.2.9 Precursor Material Flow Monitoring............................................................................ 140
8 2.2.2.10 Environmental Health and Safety: Protection of Machine Operators ......................... 142
9 2.2.2.11 Configuration Management ..................................................................................... 145
10 2.2.2.12 In-Process Monitoring .............................................................................................. 147
11 2.2.2.13 Anti-Counterfeiting .................................................................................................. 150
12 2.2.3 Post-processing ............................................................................................................. 152
13 2.2.3.1 Introduction ............................................................................................................... 152
14 2.2.3.2 Heat Treatment (metals, polymers) ............................................................................. 155
15 2.2.3.3 Hot Isostatic Pressing (HIP) (metals and ceramics) ....................................................... 160
16 2.2.3.4 Surface Texture (Surface Finish) (metals, polymers, and ceramics) ............................... 164
17 2.2.3.5 Machining (metals, polymers) ..................................................................................... 170
18 2.2.3.6 Post-curing Methods (polymers) ................................................................................. 170
19 2.2.3.7 Environmental, Health, and Safety (EHS) Hazards of Post-Processing............................ 174
20 2.2.4 Finished Material Properties ......................................................................................... 176
21 2.2.4.1 Introduction ............................................................................................................... 176
22 2.2.4.1.1 Finished Material Properties Terminology ......................................................... 176
23 2.2.4.2 Material Properties..................................................................................................... 179
24 2.2.4.2.1 Specification Content Requirements ................................................................. 180
25 2.2.4.2.2 Metals .............................................................................................................. 182
26 2.2.4.2.3 Non-Metals ...................................................................................................... 186
27 2.2.4.2.4 Test Methods (Metals and Non-Metals) ............................................................ 188
28 2.2.4.3 Component Testing .................................................................................................... 190
29 2.2.4.4 Biocompatibility of Medical AM Parts......................................................................... 191
30 2.2.4.5 Removal of AM Feedstock from Medical AM Parts ...................................................... 192
31 2.2.4.6 Chemistry .................................................................................................................. 194
32 2.2.4.7 Material Allowables ................................................................................................... 195
33 2.2.4.8 Microstructure........................................................................................................... 198
34 2.2.4.9 AM Defect Structures ................................................................................................. 201
35 2.3 Qualification & Certification .......................................................................................... 205
1 2.3.1 Introduction .................................................................................................................. 205
2 2.3.1.1 Q&C Terminology ....................................................................................................... 206
3 2.3.1.2 Q&C Framework – Prescriptive versus Performance-based .......................................... 208
4 2.3.2 Identified Guidance Documents ..................................................................................... 209
5 2.3.2.1 U.S. Food and Drug Administration (FDA) Guidance on Technical Considerations for AM
6 Devices ....................................................................................................................... 210
7 2.3.2.2 Nadcap Program ......................................................................................................... 212
8 2.3.2.3 Aerospace Mission Success Improvement Workshop (MSIW) ....................................... 213
9 2.3.2.4 Composite Materials Handbook-17 (CMH-17) and Metallic Materials Properties
10 Development and Standardization (MMPDS) Handbook .............................................. 213
11 2.3.2.5 AWS D20 .................................................................................................................... 216
12 2.3.2.6 NASA Standards for Additively Manufactured Spaceflight Hardware ............................ 217
13 2.3.2.7 ASME Y14.46 .............................................................................................................. 219
14 2.3.2.8 Underwriters Laboratories (UL) ................................................................................... 220
15 2.3.2.9 AIA Recommended Guidance for Certification of AM Components ............................... 221
16 2.3.3 User Group/Industry Perspectives on Q&C..................................................................... 222
17 2.3.3.1 Aerospace Industry ..................................................................................................... 224
18 2.3.3.1.1 Civil/Commercial Spaceflight Industry ............................................................... 224
19 2.3.3.1.2 Civil Aviation Industry ....................................................................................... 229
20 2.3.3.2 Automotive Industry ................................................................................................... 233
21 2.3.3.3 Construction Industry ................................................................................................. 234
22 2.3.3.4 Defense Industry ........................................................................................................ 234
23 2.3.3.4.1 Technical Data Package (TDP) ........................................................................... 235
24 2.3.3.4.2 Harmonizing Q&C Terminology for Process Parameters ..................................... 236
25 2.3.3.4.3 Process Approval for DoD-procured Parts .......................................................... 237
26 2.3.3.4.4 Machine Operator Training and Qualification .................................................... 239
27 2.3.3.4.5 Material Certification........................................................................................ 242
28 2.3.3.4.6 Qualification and Certification Testing of Final Parts .......................................... 242
29 2.3.3.5 Electronics and Electrical Products Industry ................................................................. 242
30 2.3.3.6 Energy Sector ............................................................................................................. 245
31 2.3.3.6.1 Nuclear Industry ............................................................................................... 245
32 2.3.3.6.2 Oil and Natural Gas Industry ............................................................................. 256
33 2.3.3.7 Medical Industry ......................................................................................................... 259
34 2.3.3.7.1 Introduction ..................................................................................................... 259
35 2.3.3.7.2 Data Output from Imaging Sources ................................................................... 260
1 2.3.3.7.3 Data Acquisition for 3D Modeling: Imaging Protocols ........................................ 261
2 2.3.3.7.4 Patient Imaging Files and Segmentation ............................................................ 263
3 2.3.3.7.5 Personnel Training for Image Data Set Processing .............................................. 265
4 2.3.3.7.6 Phantoms ......................................................................................................... 266
5 2.3.3.7.7 Medical Materials and Materials Processing ...................................................... 267
6 2.3.3.7.8 Qualification & Certification of the Finished Device ........................................... 268
7 2.3.3.7.9 Resorbable Materials ........................................................................................ 269
8 2.3.3.7.10 Biocompatibility Testing Standards Available for Resorbable and Non-resorbable
9 Materials 270
10 2.3.3.7.11 Material Control Data and Procedures .............................................................. 270
11 2.3.3.7.12 Qualification and Control of Suppliers ............................................................... 271
12 2.3.3.7.14 Validation of Sterilization Processes .................................................................. 273
13 2.3.3.7.15 Sterilization of Tissue Engineered Products ....................................................... 275
14 2.3.4 Conclusions ................................................................................................................... 276
15 2.4 Nondestructive Evaluation (NDE) ................................................................................... 277
16 2.4.1 Introduction (metals) .................................................................................................... 277
17 2.4.2 Common Defects Catalog Using a Common Language for AM Fabricated Parts ............... 281
18 2.4.2.1 Terminology ............................................................................................................... 281
19 2.4.2.2 Equipment Standardization and Demonstration of NDE Capability ............................... 283
20 2.4.3 Test Methods or Best Practice Guides for NDE of AM Parts ............................................ 286
21 2.4.3.1 NDT Reliability Assessment ......................................................................................... 288
22 2.4.3.2 3D Image Quality Indicators (IQI) ................................................................................ 291
23 2.4.3.3 Reference Radiographic Images .................................................................................. 293
24 2.4.4 Dimensional Metrology of Internal Features .................................................................. 294
25 2.4.5 Data Fusion ................................................................................................................... 297
26 2.4.6 NDE of Polymers and Other Non-Metallic Materials ....................................................... 298
27 2.4.7 NDE of Counterfeit AM Parts ......................................................................................... 300
28 2.4.8 NDE Acceptance Criteria for Fracture Critical AM Parts ................................................... 302
29 2.4.9 Effect-of-Defect of Technologically Important AM Defects ............................................. 306
30 2.4.10 In-Service NDE .............................................................................................................. 309
31 2.4.10.1 In-service Inspection ................................................................................................ 309
32 2.5 Maintenance and Repair ............................................................................................... 313
33 2.5.1 Introduction .................................................................................................................. 313
34 2.5.2 Maintenance and Sustainment of Machines................................................................... 314
35 2.5.3 Standard Repair Procedures .......................................................................................... 316
1 2.5.4 Standard Technical Inspection Processes ....................................................................... 318
2 2.5.5 Model-Based Inspection ................................................................................................ 320
3 2.5.6 Standards for Tracking Maintenance Operations ............................................................ 321
4 2.5.8 Additive Repair ............................................................................................................. 323
5 2.6 Data.............................................................................................................................. 327
6 2.6.1 Introduction .................................................................................................................. 327
7 2.6.2 Data Formats and Representation ................................................................................. 329
8 2.6.2.1 Standard Data Format for Material Characterization.................................................... 329
9 2.6.2.2 Process Specific Common Data Dictionary ................................................................... 331
10 2.6.2.3 Digital Format for In Process Monitoring Data ............................................................. 332
11 2.6.2.4 Data Capturing for Machine Logs................................................................................. 333
12 2.6.2.5 Extended Design Meta-Data Definition, Format and Management ............................... 335
13 2.6.2.6 Representation of Large Data Sets ............................................................................... 337
14 2.6.2.7 Additively Manufactured Electronics (AME) Data Transfer Format ............................... 338
15 2.6.3 Data Registration, Fusion and Visualization.................................................................... 339
16 2.6.3.1 Data Registration and Fusion ....................................................................................... 340
17 2.6.3.2 Anomaly Detection, Localization and Prediction ........................................................... 345
18 2.6.3.3 Digital Twin Development and Application ................................................................... 346
19 2.6.4 Data Management ........................................................................................................ 347
20 2.6.4.1 AM Data Collection ..................................................................................................... 348
21 2.6.4.2 Data Aggregation ........................................................................................................ 349
22 2.6.4.3 Data Retention ........................................................................................................... 350
23 2.6.5 Data Quality.................................................................................................................. 351
24 2.6.6 AM Value Chain Data Usage and Management .............................................................. 353
25 2.6.6.1 Digital Thread ............................................................................................................. 353
26 2.6.7 AM Data Security & IP Protection .................................................................................. 354
27 2.6.7.1 AM Security Guidelines ............................................................................................... 354
28 2.6.7.2 Cybersecurity.............................................................................................................. 356
29 2.6.7.3 Technical and IP Authentication and Protection........................................................... 359
30 2.6.8 Data Architecture Integration and Interoperability......................................................... 360
31 2.6.8.1 AM System Integration and Data Integration Architecture ........................................... 360
32 2.6.9 Sector Related Needs .................................................................................................... 362
33 2.6.9.1 Medical AM Design File Retention ............................................................................... 362
34 2.6.9.2 Medical AM Quality Management Systems ................................................................. 363
35 2.6.10 Data Gaps for Future Consideration .............................................................................. 365
1 3. Next Steps .................................................................................................................... 367
2 Appendix A. Glossary of Acronyms and Abbreviations .................................................................... 369
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1 Acknowledgments
2 Sincere thanks are extended to all of the individuals and organizations listed below for providing
3 technical input and/or other support associated with the development and promotion of this roadmap.
4 It is because of their involvement and contributions that this document has been made possible. Special
5 thanks go to those who submitted written content and comments for consideration, as well as those
6 who provided editorial review.
7 The roadmap is based on a consensus of those who actively participated in its development and does
8 not necessarily reflect the views of the individuals or organizations listed below. The employment status
9 and organizational affiliation of participants may have changed during the course of this project.
10 Major funding for the initiative was provided by America Makes via a cooperative agreement with the
11 U.S. Department of Defense (DoD).
12 To be filled in.
Organization Name of Individual(s)
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14 AMSC Chair
2
15 AMSC Vice Chair
3
16 Advisory Group Member
4
17 Working Group Co-Chair
18 Parentheses following a name signify participation also on behalf of another organization.
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1 Executive Summary
2 In March, 2016, America Makes and the American National Standards Institute (ANSI) launched the
3 America Makes & ANSI Additive Manufacturing Standardization Collaborative (AMSC). The AMSC was
4 established to coordinate and accelerate the development of industry-wide additive manufacturing
5 (AM) standards and specifications consistent with stakeholder needs and thereby facilitate the growth
6 of the AM industry.
7 America Makes is the nation’s leading public-private partnership for additive manufacturing technology
8 and education. Its members work together to accelerate the adoption of AM and the nation’s global
9 manufacturing competitiveness. Founded in 2012 as the Department of Defense’s manufacturing
10 innovation institute for AM, and first of the Manufacturing USA network, America Makes is managed by
11 the National Center for Defense Manufacturing and Machining (NCDMM).
12 Founded in 1918, ANSI serves as administrator and coordinator of the private-sector led voluntary
13 standardization system in the United States. As a neutral facilitator, the Institute has a successful track
14 record of convening stakeholders from the public and private sectors to define standardization needs for
15 emerging technologies and to address national and global priorities.
16 The catalyst for the AMSC was the recognition that a number of SDOs are engaged in standards-setting
17 for various aspects of additive manufacturing, prompting the need for coordination to maintain a
18 consistent, harmonized, and non-contradictory set of additive manufacturing standards. The AMSC does
19 not develop standards. Rather, it identifies standardization needs and facilitates coordination among
20 standards developing organizations (SDOs) and others.
21 This Standardization Roadmap for Additive Manufacturing, Version 3.0 is an update to version 2.0 of this
22 document published in June 2018. It identifies existing standards and standards in development,
23 assesses gaps, and makes recommendations for priority areas where there is a perceived need for
24 additional standardization and/or pre-standardization research and development. The focus is industrial
25 additive manufacturing, across market sectors that are using AM.
26 The roadmap has identified a total of 134 open gaps and corresponding recommendations across six
27 topical areas: 1) design; 2) process and materials (precursor materials, process control, post-processing,
28 and finished material properties); 3) qualification and certification; 4) nondestructive evaluation; 5)
29 maintenance and repair; and 6) data. Of that total, 51 gaps/recommendations have been identified as
30 high priority, 60 as medium priority, and 23 as low priority. A “gap” means no published standard or
31 specification exists that covers the particular issue in question. In 83 cases, additional research and
32 development (R&D) is needed.
33 As with the earlier versions of this document, the hope is that the roadmap will see broad adoption by
34 the user community and will facilitate a more coherent and coordinated approach to the future
35 development of standards and specifications for additive manufacturing. It is envisioned that the
36 roadmap will be widely promoted and that progress on its implementation will be tracked.
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1 Highlights of Roadmap Version 3.0
2 Summary Table of Gaps and Recommendations
3 Accompanying this roadmap is a Summary Table of Gaps and Recommendations identified in this
4 document. The table is actually a sortable spreadsheet. Sorting and filtering of gaps can be done on
5 columns that may be of interest such as R&D Needed, Priority, Status of Progress, Lifecycle Area, Sector,
6 Material Type, Process Category, and Qualification and Certification (Q&C) Category. In the case of
7 Priority and Status of Progress, there are some instances where more than one value is listed, for
8 example, in relation to different Material Types.
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10 Consult chapter 2 of the roadmap itself for the full discussion of issues and identified published and in-
11 development standards that precede each gap, along with the text of the gaps.
12 Significant Changes from Version 2.0
13 The process of developing this roadmap version 3.0 included a comprehensive review of all content in
14 the Standardization Roadmap for Additive Manufacturing (version 2.0, June 2018) including all
15 previously identified gaps for ongoing relevancy. Many sections and previously identified gaps were
16 substantially revised, and many new sections and gaps were added. Below are additional changes from
17 version 2.0 that might not otherwise be immediately apparent from a review of the table of contents or
18 the gaps themselves. This is not an exhaustive list of all changes that were made to the document.
19 High-Level Structural and Content Changes
20 - Links to relevant published and in-development standards continue to be listed in the roadmap
21 text ahead of the corresponding gaps. There is no longer a separate spreadsheet of standards
22 accompanying the roadmap.
23 - The introduction has been streamlined. Section 1.4, List of Organizations Covered in this
24 Roadmap, has been added, replacing what was section 1.5 in v2.
25 - An entire new section, 2.6 on Data across the AM lifecycle, has been added.
26 - Carryover gaps from version 2.0 retain their original numbering except where noted. Design
27 section gaps are now are renumbered “DE” and “DA” is used for Data section gaps.
28 Repositioned v2 Roadmap Sections/Subsections
29 - 2.2.1.4, Precursor Material Handling: Use, Reuse, Mixing, and Recycling Feedstock (was 2.2.2.7
30 in v2)
31 - 2.6.7.2, Cybersecurity (was 2.5.7 in v2)
32 Summary of Gaps
33 - 134 open gaps are identified in version 3.0, including 51 new gaps. Of these
34  51 are High priority* (should be addressed in 0-2 years)
1 - 60 are Medium priority (should be addressed in 2-5 years)
2  23 are Low priority (should be addressed in 5+ years)
3 - 83 gaps require research and development
4 * priority in terms of desired timeframes for having a published standard
5 Breakdown of Open Gaps by Lifecycle Area
Section High Priority Medium Priority Low Priority Total

(0-2 years) (2-5 years) (5+ years)
Design 8 13 2 23
Precursor Materials 2 9 7 18
Process Control 2 8 3 13
Post-processing 1 4 3 8
Finished Material Properties 9 0 1 10
Qualification & Certification 11 6 4 21
Nondestructive Evaluation 5 6 1 12
Maintenance & Repair 1 4 2 7
Data 12 10 0 22
Total 51 60 23 134
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7 Closed v2 Gaps (4)
8 - Gap DE1: Decision Support: Additive vs. Traditional

9 - Gap DE2: Decision Support: Additive Processes
10 - Gap DE19: Organization Schema Requirement and Design Configuration Control
11 - Gap DE21: New Terminology in Design Documentation
12 Withdrawn v2 Gaps (8)
13 - Gap D6: Software-encodable/Machine-readable Guidelines

14 - Gap D22: In-Process Monitoring
15 - Gap D24: An Acquisition Specification
16 - Gap PM3: Particle Size and Particle Size Distribution
17 - Gap PC10. Re-use of Material that Has Not Been Processed
18 - Gap PC11: Re-use of Material that Has Been Processed
19 - Gap QC12: Resorbable Materials
20 - Gap M3: AM Level of Repair Analysis
21 Repositioned v2 Gaps
22 - Gap PM9: Characterization of Material Extrusion Feedstock (Filaments & Pellets) under 2.2.1.5.3
23 (was under 2.2.1.4.5 in v2)
24 - Gap PM13 (was Gap PC9 in v2): Environmental Conditions: Effects on Materials under 2.2.1.2.1
25 (was under 2.2.2.7 in v2)
1 - Gap PM18 (was Gap PC7 in v2): Recycle & Reuse of Materials under 2.2.1.4 (was 2.2.2.7 in v2)
2 - Gap DA9 (was Gap NDE5 in v2): Data Fusion
3 - Gap DA18 (formerly M7 in V2): Additive Manufacturing Supply Chain Security
1 Breakdown of High, Medium, and Low Priority Gaps
2 Note: The table below contains navigational hyperlinks to the full text of the gaps as they appear in the
3 roadmap.
4 Key:
5 DE – Design (2.1) 10 QC – Qualification & Certification (2.3)

6 PM – Precursor Materials (2.2.1) 11 NDE – Nondestructive Evaluation (2.4)
7 PC – Process Control (2.2.2) 12 M – Maintenance & Repair (2.5)
8 P – Post-processing (2.2.3) 13 DA – Data (2.6)
9 FMP – Finished Material Properties (2.2.4)
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Section # Gap #, Title and Description High Medium Low

2.1.2.1 Gap DE1: Decision Support: Additive vs. Traditional (Closed) X
2.1.2.1 Gap DE2: Decision Support: Additive Processes (Closed) X
2.1.2.2 Gap DE3: Process-Specific Design Guidelines X
2.1.2.3 Gap DE4: Design Guides for Specific Applications X
2.1.2.4 Gap DE5: Support for Customizable Guidelines X
2.1.2.5 Gap DE7: Design Guide for Post-processing X
2.1.2.6 Gap DE14: Designing to be Cleaned X
2.1.2.7 Gap DE15: Design of Test Coupons X
2.1.2.7 Gap DE16: Verifying Functionally Graded Materials (FGM) X
2.1.3.1 Gap DE8: Machine Input and Capability Report X
2.1.3.2 Gap DE9: AM Simulation Benchmark Model/Part Requirement X
2.1.3.3 Gap DE27: Standardized Design for Additive Manufacturing X
(DFAM) Process Chain
2.1.4.1 Gap DE10: Design for As-built Assembly X
2.1.4.2 Gap DE11: Design for 3D Printed Electronics X
2.1.4.3 Gap DE12: Imaging Consistency X
2.1.4.3 Gap DE13: Image Processing and 2D to 3D Conversion X
2.1.5.1 Gap DE17: Contents of a Data Package X
2.1.5.2 New Gap DE30: STEP Based 3D PDF X
2.1.5.2 New Gap DE31: Feature-based Support for STEP X
2.1.5.3 Gap DE18: New Dimensioning and Tolerancing Requirements X
2.1.5.4 Gap DE19: Organization Schema Requirement and Design X
Configuration Control (Closed)
2.1.5.5 Gap DE20: Neutral Build File Format X
2.1.5.6 Gap DE21: New Terminology in Design Documentation (Closed) X
2.1.5.8 Gap DE28: Specification of Surface Finish X
2.1.5.8 Gap DE23: Documentation of New Functional and Complex X
Surface Features
2.1.6 Gap DE26: Design for Measurement of AM Features/Verifying the X
Designs of Features such as Lattices, etc
2.1.7 New Gap DE29: Best Practices for Design for Anti-counterfeiting X
2.2.1.2 New Gap PM11: Segregation of Powder X
2.2.1.2 New Gap PM12: Requirements for Large Storage and Transport X
Vessels of Powder Feedstock
2.2.1.2.1 Gap PM13 (was Gap PC9 in v2): Environmental Conditions: Effects X
on Materials
2.2.1.3.1 New Gap PM14: Test Method to Assess Hydrogen Content in X
Aluminum Powder Feedstocks
2.2.1.3.1 New Gap PM15: Identification and Quantification of Impurities in X
Chemical Compositions
2.2.1.3.1 Gap PM8: Use of Recycled Polymer Precursor Materials X
2.2.1.3.2 Gap PM1: Flowability X
2.2.1.3.3 Gap PM2: Spreadability X
2.2.1.3.5 New Gap PM17: Error Quantification of PSD Measurement X
Methods
2.2.1.3.5 New Gap PM16: Universal Reference Standard on Size Distribution X
2.2.1.3.6 Gap PM4: Particle Morphology X
2.2.1.3.7 Gap PM5: Metal Powder Feedstock Sampling X
2.2.1.3.8 Gap PM6: Hollow Particles and Hollow Particles with Entrapped X
Gas
2.2.1.3.9 Gap PM7: Metal Powder Specifications for Procurement Activities X
in Support of AM
2.2.1.4 Gap PM18 (was Gap PC7 in v2): Recycle & Reuse of Materials X
2.2.1.4.1 New Gap PM19: Terminology Related to Reuse of Feedstock X
Materials
2.2.1.5.3 Gap PM9: Characterization of Material Extrusion Feedstock X
(Filaments & Pellets)
2.2.1.6.3 Gap PM10: Sampling of Open Liquid Feedstock System X
2.2.2.10 Gap PC14: Environmental Health and Safety: Protection of X
Machine Operators
2.2.2.11 Gap PC15: Configuration Management X
2.2.2.12 Gap PC16: In-Process Monitoring X
2.2.2.2 Gap PC1: Digital Format and Digital System Control X
2.2.2.3 Gap PC2: Machine Calibration and Preventative Maintenance X
2.2.2.3 Gap PC3: Machine Health Monitoring X
2.2.2.4 Gap PC4: Machine Qualification X
2.2.2.5 Gap PC5: Parameter Control X
2.2.2.6 Gap PC6: Adverse Machine Environmental Conditions: Effect on X
Component Quality
2.2.2.7 Gap PC8: Stratification X
2.2.2.8 New Gap PC18: Powder Blending and Powder Mixing Terminology X
2.2.2.9 Gap PC12: Precursor Material Flow Monitoring X
2.2.2.9 Gap PC13: Flow Parameters for Material Jetting X
2.2.3.1 Gap P1: Post-processing Qualification, Validation, and Production X
Builds
2.2.3.2 Gap P2: Heat Treatment (HT)-Metals X
2.2.3.2 Gap P7: Heat Treatment (HT)-Polymers X
2.2.3.3 Gap P3: Hot Isostatic Pressing (HIP) X
2.2.3.4 Gap P4: Surface Texture (Surface Finish) X
2.2.3.6 Gap P5: Use of Post-cure to Reduce Toxic Gases from Uncured X
Polymer Feedstock
2.2.3.6 Gap P6: Guidelines for Post-curing AM Plastics to Address X
Outgassing and Offgassing
2.2.3.7 New Gap P8: EHS Hazards Related to Post-Processing Tasks X
2.2.4.1.1 New Gap FMP6: Finished Material Properties Terminology X
2.2.4.2.1 New Gap FMP7: Material Properties: Specification Content X
Requirements
2.2.4.2.2 Gap FMP1: Material Properties (Metals) X
2.2.4.2.3 New Gap FMP8: Material Properties (Non-Metals) X
2.2.4.2.4 New Gap FMP9: Material Properties: Test Methods (Metals and X
Non-Metals)
2.2.4.5 Gap FMP3: Removal of AM Feedstock from Medical AM Parts X
2.2.4.7 Gap FMP4: Material Allowables X
2.2.4.8 Gap FMP5: Microstructure X
2.2.4.9 New Gap FMP10: Catalogs of process specific defect types and X
terminology
2.2.4.9 New Gap FMP11: Assessment of models linking defect structures X
and material performance
2.3.1 Gap QC1: Harmonization of AM Q&C Terminology X
2.3.1 Gap QC2: AM Part Classification System for Consistent X
Qualification Standards
2.3.3.4.2 Gap QC3: Harmonizing Q&C Terminology for Process Parameters X
2.3.3.4.3 Gap QC4: Process Approval for DoD-procured Parts X
2.3.3.4.4 Gap QC5: Machine Operator Training and Qualification X
2.3.3.5 New Gap QC17: Additively Manufactured Electronics (AME) X
2.3.3.6.1 New Gap QC18: Production and Use of AM Parts in Nuclear X
Applications and Facilities
2.3.3.6.1 New Gap QC19: Nuclear AM Component In-service Performance X
2.3.3.6.1 New Gap QC20: Nuclear Industry Use of Artificial Intelligence (AI) X
and Machine/System Learning Technologies to Qualify AM Parts
2.3.3.6.1 New Gap QC21: Nuclear Industry Use of Material and Production X
Data Combined with Digital Analysis and Diagnostic Informed
Qualification of AM Components
2.3.3.6.1 New Gap QC22: Use and Qualification of AM Non-steel Advanced X
Materials in Support of New or Advanced Nuclear Fuel and High-
temperature Reactor Applications
2.3.3.6.2 New Gap QC23: Susceptibility of AM Products to Corrosion and X
Environmental Cracking Mechanisms
2.3.3.7.11 Gap QC13: Material Control Data and Procedures X
2.3.3.7.13 Gap QC10: Verification of 3D Model X
2.3.3.7.14 Gap QC15: Sterilization of AM Medical Products X
2.3.3.7.15 Gap QC16: Sterilization of 3D Printed Tissue Engineered Products X
2.3.3.7.2 Gap QC6: Importing 3D Source Data to CAD Application for X
Creation of Design File
2.3.3.7.3 Gap QC7: Imaging Protocols X
2.3.3.7.4 Gap QC14: Segmentation X
2.3.3.7.5 Gap QC9: Personnel Training for Image Data Set Processing X
2.3.3.7.6 Gap QC8 Phantoms X
2.4.10 New Gap NDE10: In-service Inspection X
2.4.2 Gap NDE1: Terminology for the Identification of AM Anomalies X
Interrogated by NDE Methods
2.4.2 Gap NDE2: Standard for the Design and Manufacture of Physical X
Reference Standards, Image Quality Indicators, and
Representative Quality Indicators to Demonstrate NDE Capability
2.4.3 Gap NDE3: Standard Guide for the Application of NDE to Objects X
Produced by AM Processes
2.4.3.1 New Gap NDE11: Reliability of NDT X
2.4.3.2 New Gap NDE12: 3D Image Quality Indicator for determining the X
sensitivity of a CT system
2.4.3.3 New Gap NDE13: Reference Radiographic Images and Standards X
for Additive Manufacturing Anomalies
2.4.4 Gap NDE4: Dimensional Metrology of Internal Features X
2.4.6 Gap NDE6: NDE of Polymers and Other Non-Metallic Materials X
2.4.7 Gap NDE7: NDE of Counterfeit AM Parts X
2.4.8 Gap NDE8: NDE Acceptance Criteria for Fracture Critical AM Parts X
2.4.9 New Gap NDE9: Effect-of-Defect of AM Defects Detectable by NDE X
2.5.2 Gap M1: AM Analyses in RCM and CBM X
2.5.3 Gap M9: Laser Based Additive Repair X
2.5.4 Gap M4: Physical Inspection of Parts Repaired Using AM X
2.5.5 Gap M5: Model-Based Inspection X
2.5.6 Gap M6: Tracking Maintenance X
2.5.7 Gap M8: Surface Preparation for Additive Repair X
2.5.7 New Gap M10: Best Practices on Repair using Additive X
Manufacturing
2.6.2.1 New Gap DA1: Standard Data Format for Material X
Characterization
2.6.2.2 New Gap DA2: Process Specific Common Data Dictionary X
2.6.2.3 New Gap DA3: Digital Format for In Process Monitoring Data X
2.6.2.4 New Gap DA4: Data Capturing for Machine Logs During a Build X
2.6.2.5 New Gap DA5: Extended Design Specifications for Meta-Data X
Format Standardization
2.6.2.6 New Gap DA6: Specifications and Representations for AM Big Data X
2.6.2.7 New Gap DA7: Additively Manufactured Electronics (AME) Data X
Transfer Format
2.6.3.1 New Gap DA8: Best Practices and/or Specifications for Registering X
and Fusing Data Sets During the AM Manufacturing and Inspection
Process
2.6.3.1 Gap DA9 (formerly NDE5 in V2): Data Fusion X
2.6.3.2 New Gap DA10: Best Practices for Anomaly Characterization and X
Localization for Part Defect Prediction Purpose
2.6.3.3 New Gap DA11: Consistent Part Traceability and Provenance X
(Digital Twin)
2.6.4.1 New Gap DA12: Best Practices and Guidance for AM Data X
Collection
2.6.4.2 New Gap DA13: Data Aggregation of Time Series and Object Data X
2.6.4.3 New Gap DA14: Data Retention Guidelines X
2.6.5 New Gap DA15: Assessment and Specifications of AM Data Quality X
2.6.6.1 New Gap DA16: Reference Workflow (Digital thread) for AM Part X
Fabrication
2.6.7.1 New Gap DA17: AM-Specific Security Guidance X
2.6.7.2 Gap DA18 (formerly M7 in V2): Additive Manufacturing Supply X
Chain Security
2.6.7.3 New Gap DA19: Technical and IP Authentication and Protection X
2.6.8.1 New Gap DA20: AM Machine Data Framework and Guideline for X
Automated AM Data Integration and Management
2.6.9.1 New Gap DA21: Medical AM Design File Retention X
2.6.9.2 New Gap DA22: Quality Management of Medical AM Files X
Total 52 63 23
1
1 1. Introduction
2 Additive Manufacturing (AM), sometimes referred to as three-dimensional printing (3DP), encompasses
3 a variety of processes wherein a 3D object is produced from a digital model by adding successive layers
4 of material to create the object. In name, it stands in contrast to traditional or subtractive
5 manufacturing where material is removed through machining or other means to create an object.
6 AM as a field has grown significantly over many years, where it offers significant potential cost savings
7 and shortening of the supply chain by allowing parts to be manufactured on-site rather than at a distant
8 supplier. Its use is also driven by AM-enabled designs that provide unique performance characteristics
9 and efficiencies that cannot be achieved through subtractive machining.
10 The process for making production AM parts may be summarized as follows:
11  Design the part for AM

12  Specify the materials from which the part will be built
13  Establish build parameters
14  Control the AM build process to achieve the desired part’s dimensions, structure, and
15 performance properties
16  Perform post-processing steps
17  Final testing
18  Certify the part’s fitness-for-use
19  Maintain/repair machines, parts, and systems
20 Standards, specifications, and related conformance and training programs, are integral to this process
21 and are a key enabler for the large-scale introduction and growth of AM.
22 1.1 Background on the AMSC and Catalyst for this Roadmap

23
24 The America Makes & ANSI Additive Manufacturing Standardization Collaborative (AMSC) was
25 established in the first quarter of 2016. America Makes and the American National Standards Institute
26 (ANSI) entered into an agreement to create a roadmap that would identify AM standards and
27 specifications that have been published, or that are in development, and or that are otherwise needed.
28 Federal agencies, including the National Institute of Standards and Technology (NIST), Department of
29 Defense (DoD), Federal Aviation Administration (FAA), and others, as well as several standards
30 development organizations (SDOs), supported the formation of the AMSC.
31
32 America Makes, as the nation’s leading public-private partnership for additive manufacturing technology
33 and education, engaged ANSI because of the Institute’s role as neutral coordinator and administrator of
34 the U.S. private sector system of voluntary standardization, and its past success in producing consensus-
35 based standardization roadmaps when there was a perceived need for such coordination. The AMSC has
36 not undertaken to develop standards, as ANSI’s charter expressly prohibits the Institute from doing so.
1
2 The establishment of the AMSC complemented America Makes’ formulation of a standards strategy for
3 AM. America Makes recognized the need for, and importance of, AM standards and conformance
4 procedures to advance the adoption of AM technologies in the U.S., for example, for use by industry
5 during qualification of AM materials, processes, and systems, and by regulatory bodies during
6 certification of AM parts.
7
8 America Makes also recognized that a number of SDOs, both U.S. based and elsewhere, are engaged in
9 producing voluntary consensus standards for AM to meet the needs of different industries. The
10 existence of these parallel standards-setting activities increased the need for U.S. leadership and
11 coordination toward achieving a consistent, harmonized, and non-contradictory set of AM standards for
12 use by the AM community.
13
14 Thus, the AMSC project endeavored to bring together the community of stakeholders, including original
15 equipment manufacturers (OEMs), industry, government, academia, and SDOs, to develop a coherent
16 roadmap of existing and needed standards for additive manufacturing. Participation in the effort was
17 open to any AM stakeholder having operations in the United States, regardless of America Makes
18 and/or ANSI membership status.
19
20 Version 1.0 of the roadmap was published in February 2017, with a heavy focus on metallic AM and
21 largely informed by interests in the aerospace, defense, and medical sectors. Version 2.0 of the roadmap
22 was published in June 2018 with expanded content on polymer AM across the document and additional
23 input from other sectors such as the electronic and electrical products industry. Building on the earlier
24 efforts, version 3.0 introduces a section on data and again expands the use of AM by other industry
25 sectors such as oil & natural gas, and nuclear.
26 Over the years, the roadmap has been promoted at various industry events. During 2020-2021, the
27 AMSC held a series of virtual events addressing different aspects of the roadmap, including process
28 control to enable qualification, design for additive manufacturing, feedstock materials, and
29 inspection/monitoring. The AMSC also issued semi-annual progress reports to maintain the roadmap as
30 a “living document,” tracking the publication of new standards or the initiation of new standards
31 projects by SDOs to address the gaps and recommendations outlined in the roadmap.
32 Following a survey about use of the roadmap conducted in early 2022, the AMSC advisory group – a
33 steering committee comprising industry, government, and SDO representatives that provides overall
34 strategic direction – concluded that it was time to again update the document to ensure that it remains
35 relevant and aligns with current practices and stakeholder needs.
36
1 1.2 Roadmap Goals, Boundaries, and Target Audience
2
3 Ultimately, the goal of this roadmap is to coordinate and accelerate the development of industry-wide
4 AM standards and specifications, consistent with stakeholder needs. The intent is to facilitate the
5 growth of the AM industry.
6 Building on the prior AMSC efforts, this roadmap seeks to describe the current and desired future
7 standardization landscape that will support and facilitate the widespread adoption of AM. It identifies
8 key issues, notes relevant published and in-development standards, and makes recommendations to
9 address gaps in standards. This includes recommending pre-standardization research and development
10 (R&D) where needed. It also includes identification of prioritized timeframes for when standardization
11 work should occur and SDOs or other organizations that may be able to lead such work. It seeks to
12 facilitate coordination among SDOs to maintain a common framework of AM standards and
13 specifications.
14 The roadmap’s focus is industrial AM, across market sectors that are using AM technologies. In terms of
15 what is out of scope, the consumer desktop 3D printing market is not addressed in this roadmap.
16 The roadmap is targeted toward a broad audience including OEMs, material producers, government and
17 industry users of AM, SDOs, the R&D community, and others. The roadmap may assist:
18  SDOs in identifying opportunities to coordinate and collaborate.

19  Government agencies in advancing U.S. policy objectives.
20  Industry with deployment of AM technologies and identifying commercial opportunities.
21  All stakeholders with focusing standards participation resources.
22  Raising awareness and understanding of the issues around AM.
23 It is assumed that those reading the roadmap are directly affected stakeholders who have some
24 understanding of AM technologies.
25
26 1.3 Roadmap Structure

27 To develop the roadmap, the AMSC took the approach of conducting a life-cycle assessment of
28 producing an AM part, from initial design, through production, and ending with post-production testing,
29 qualification, and maintenance. Thus, it organized itself around nine working groups covering Design,
30 Precursor Materials, Process Control, Post-processing, Finished Materials Properties (FMP), Qualification
31 and Certification (Q&C), Nondestructive Evaluation (NDE), Maintenance and Repair, and Data.
32 Chapter 2 of the roadmap provides the context and explanation for why specific issues were considered
33 important and subsequently assessed as part of the roadmap. This is the gap analysis evaluation of
34 existing and needed standards, specifications, and conformance programs. A “gap” is defined as
35 meaning that no published standard, specification, etc. exists that covers the particular issue in question.
1 Where gaps are identified and described, they include an indication whether additional pre-
2 standardization R&D is needed, a recommendation for what should be done to fill the gap, the priority
3 for addressing the gap, and an organization(s) – for example, an SDO or research organization – that
4 potentially could carry out the R&D and/or standards development based on its current scope of
5 activity. Where more than one organization is listed, there is no significance to the order in which the
6 organizations are listed.
7 Carryover gaps from version 2.0 retain their original numbering except where noted and include a
8 descriptor on the status of progress to address the gap. These are described as: Closed (completed) or,
9 using a traffic light analogy, Green (moving forward), Yellow (delayed), Red (at a standstill), Not Started,
10 Withdrawn, or Unknown. Any significant changes from version 2.0 are also summarized in a narrative
11 update statement. New Gaps for version 3.0 are identified as such, starting with the next number in
12 sequence from version 2.0 for a particular section. In cases where version 2.0 or even 1.0 gaps were
13 withdrawn, there may be “gaps” in the numbering.
14 Each gap is identified as being high, medium, or low priority. In terms of acting to address the priorities,
15 the desired timeframes for having a published standard available are as follows: high priority (0-2 years),
16 medium (2-5 years), and low (5 + years). In arriving at the priority level, consideration is supposed to be
17 given to the criteria described in Table 1 below.
18 Table 1: Prioritization Matrix

Criteria (Make the C-A-S-E for the Priority Level) Scoring Values
Criticality (Safety/Quality Implications). How important is the 3 - critical

project? How urgently is a standard or guidance needed? What
2 - somewhat critical
would be the consequences if the project were not completed or
undertaken? A high score means the project is more critical.
1 - not critical
Achievability (Time to Complete). Does it make sense to do this 3 - project near completion
project now, especially when considered in relation to other
projects? Is the project already underway or is it a new project? A 2 - project underway
high score means there's a good probability of completing the
project soon. 1 - new project
Scope (Investment of Resources). Will the project require a

significant investment of time/work/money? Can it be completed
3 - low resource requirement
with the information/tools/ resources currently available? Is pre-
standardization research required? A high score means the project
2 - medium resource requirement
can be completed without a significant additional investment of
resources. 1 - resource intensive
Effect (Return on Investment). What impact will the completed 3 - high return
project have on the industry? A high score means there are
significant gains for the industry by completing the project. 2 - medium return
1 - low return
Score Rankings
High Priority (a score of 10-12)
Medium Priority (a score of 7-9)
Low Priority (a score of 4-6)
1
2 In version 3.0, additional metadata has been added to the gaps. This includes: a description of R&D
3 expectations, the applicable AM lifecycle area(s), relevant sector(s), material type(s), process
4 category(ies), Q&C category(ies), and current alternative being used until an AM standard or
5 specification is available to address the issue. Gaps can be sorted/filtered using the Summary Table of
6 Gaps and Recommendations sortable spreadsheet. Full text describing the issues and published and in
7 development standards precedes each gap in chapter 2.
8 Readers are encouraged to take note of gaps and recommendations that may not be specific to their
9 industry sector.
10 The final chapter briefly describes next steps.
11 1.4 List of Organizations Covered in this Roadmap

12 The following organizations identified in this roadmap have standards, specifications, guidance materials
13 or R&D activities that support additive manufacturing.
3MF 3MF Consortium

AAMI Association for the Advancement of Medical Instrumentation
AATB American Association of Tissue Banks
ABS ABS Group
ACR American College of Radiology
AFRL U.S Air Force Research Laboratory
Aerospace Corporation, The
AIA Aerospace Industries Association
AMDC Additive Manufacturing Data Consortium (SAE-ITC)
America Makes
AMMTO Advanced Materials and Manufacturing Technologies Office
AMO Advanced Manufacturing Office
AMPP Association for Materials Protection and Performance
ANSI American National Standards Institute
API American Petroleum Institute
ARL Applied Research Laboratory (Penn State)
ASM ASM International
ASME American Society of Mechanical Engineers
ASSP American Society of Safety Professionals
ASTM ASTM International
AWS American Welding Society
BINDT British Institute of Non-Destructive Testing
Computational Materials for Qualification and Certification Steering Group
CM4QC (NASA)
CMDS Consortium for Materials Data Standardization (ASTM)
DHS U.S. Department of Homeland Security
DICOM DICOM
DIN Deutsches Institut für Normung
DMSC Dimensional Metrology Standards Consortium (QiF)
DoD U.S. Department of Defense
EASA European Union Aviation Safety Agency
EPA U.S. Environmental Protection Agency
EPRI Electric Power Research Institute
FAA U.S. Federal Aviation Administration
FDA U.S. Food and Drug Administration
GAO U.S. General Accounting Office
HDF The HDF Group
HL7 HL7 International
ICNDT International Committee for Non-Destructive Testing SIG
IEC International Electrotechnical Commission
IEEE Institute of Electrical and Electronics Engineers
IETF Internet Engineering Task Force
IPC Association Connecting Electronics Industries
ISA International Society of Automation
ISO International Organization for Standardization
JMADD Joint Metals Additive Database Definition
LANL Los Alamos National Laboratory
MIT Massachusetts Institute of Technology
MITA Medical Imaging & Technology Alliance
MPIF Metal Powder Industries Federation
MTDA Montana Digital Academy
NASA National Aeronautics and Space Administration
NAVSEA Naval Sea Systems Command
NAWC Naval Air Warfare Center
NCAMP National Center for Advanced Materials Performance
NDIA National Defense Industrial Association
NEI Nuclear Energy Institute
NEMA National Electrical Manufacturers Association
NFPA National Fire Protection Association
NIH National Institute of Health
NIOSH National Institute for Occupational Safety and Health
NIST National Institute of Standards and Technology
NRC Nuclear Regulatory Commission
OSHA The Occupational Safety and Health Administration
Phantoms Phantoms Foundation
PWG Printer Working Group
RSNA Radiological Society of North America
SABIC SABIC
SAE SAE International
SME SME
TAPPI TAPPI
UL Underwriters Laboratory
USP United States Pharmacopeia
VDI The Association of German Engineers
1
1
2
3
4
5
6
7
8
9
10
12
1 2. Gap Analysis of Standards and Specifications
2 This roadmap chapter sets forth a description of key issues; relevant published standards and
3 specifications, as well as those in development; recommendations on the need for additional R&D
4 and/or standards and specs, as well as priorities for their development; and the organization(s) that
5 potentially could perform the work. It is divided into several sections corresponding to the AMSC
6 working groups. These are: Design, Process and Materials, Qualification and Certification,
7 Nondestructive Evaluation, Maintenance and Repair, and Data. The Process and Materials section is
8 further divided into four sections corresponding to the AMSC subgroups on Precursor Materials, Process
9 Control, Post-processing, and Finished Materials Properties.
10 2.1 Design
11 2.1.1 Introduction
12 Additive manufacturing offers unique design opportunities not afforded by traditional manufacturing
13 processes. These opportunities include unique lattice structures and material gradients as well as other
14 novel designs such as the creation of inseparable assemblies or embedded electronics.
15
16 This section will assess the currently available and developing industry standards and specifications
17 relevant to the AM design process. Specifically, design guides, design tools, design documentation, and
18 design verification and validation (V&V) will be discussed as well as design standards relevant to specific
19 applications such as medical and electronics. Gaps in applying these standards and methods to AM shall
20 be identified, and recommendations will be made to address them.
21
22 AM designs must ultimately be documented in a product definition data set that includes all of the
23 information necessary to build a part. However, AM presents challenges to designers seeking to apply
24 traditional design methods for part manufacturing. To aid them, the existing design systems, processes,
25 and methodologies must be evaluated for their applicability to AM, and in special cases new ones may
26 be required.
27 2.1.2 Design Guides

28 Design guidelines for AM serve to support users in both design and manufacturing decisions. Guidelines
29 are used to highlight AM process capabilities and inform users on process limitations and requirements.
30 Different AM processes have different design requirements, manufacturing requirements, and
31 manufacturing capabilities. Design guides potentially could also be used to help designers consider other
32 factors such as reliability, cost assessment, logistics, and risk assessment.
33 As AM has matured as a technology, design guidelines have become more prevalent and more
34 advanced. Guidelines are developed as process-independent, process-specific, manufacturer-specific,
35 and application-specific. Design guides do not necessarily need to be developed by SDOs. They are also
1 available from equipment manufacturers and service providers, though these are not generally
2 identified in this document.
3 2.1.2.1 General Guides for AM
4 From the standards perspective, ASTM F42 and ISO TC261 have taken the lead in the development of
5 design guidelines.
6 Published Standards
7  ISO/ASTM 52910-18, Additive manufacturing — Design — Requirements, guidelines and

8 recommendations (ASTM F3154-18).
9  ASTM F3488-22, Guide for Additive Manufacturing Design - Decision Guide (F42.04, formerly
10 WK64190) discusses advantages and comparisons of different AM processes versus traditional
11 manufacturing as well as a flow chart to aid in decision-making related.
12 In Development Standards
13  ASTM WK83512, Revision of ISO/ASTM52910-18 Additive manufacturing — Design —

14 Requirements, guidelines and recommendations (F42.04)
15
16 Gap DE1: Decision Support: Additive vs. Traditional. Currently there is no standard that helps users
17 understand the advantages/disadvantages of AM processes versus traditional manufacturing processes
18 while also providing decision criteria so informed design/manufacturing decisions can be made.
19 R&D Needed: ☐Yes; ☒No; ☐Maybe
20 R&D Expectations: N/A
21 Recommendation: Develop a guideline that helps understand trade-offs between AM processes and
22 traditional processes (e.g., sacrifice design freedom for greater certainty of established processes in
23 terms of material properties, reliability, etc.). This gap does not recommend qualification or certification
24 requirements but may help designers consider certification needs and requirements for the parts,
25 equipment, etc.
26 Priority: High; Medium; ☐ Low
27 Organization: ISO/ASTM, AWS, SAE, SME, ASME
28 Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished

29 Material Properties; ☐Qualification & Certification; ☐Nondestructive Evaluation; ☐Maintenance and
30 Repair; ☐Data
31 Sectors: ☒All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☐Electronics;

32 ☐Energy; ☐Medical; ☐Spaceflight; ☐Other (specify) ______________________
1 Material Type: ☒All/Material Agnostic; ☐Metal; ☐Polymer; ☐Ceramic; ☐Composite
2 Process Category: ☒All/Process Agnostic; ☐Binder Jetting; ☐Directed Energy Deposition; ☐Material
3 Extrusion; ☐Material Jetting; ☐Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photopolymerization
4 Q&C Category: ☐Materials; ☐Processes/Procedures; ☐Machines/Equipment; ☐Parts/Devices;

5 ☐Personnel/Suppliers; ☐Other (specify) Not Q&C Related
6 Current Alternative: Organizational level internal evaluations, traditional manufacturing decision-

7 making processes.
8 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☒Closed;
9 ☐New
10 V3 Update: See standards activity above. Commercial tools are available.

11
12 Gap DE2: Decision Support: Additive Processes. The version 1.0 gap stated that there is no standard
13 that normalizes the characteristics of the general AM process and ranks the pros/cons or
14 strengths/weaknesses of each process, allowing users to make informed decisions about which AM
15 process best suits their need. In 2018, ISO/ASTM published ISO/ASTM 52910-18, Additive manufacturing
16 — Design — Requirements, guidelines and recommendations)..The standard briefly addresses AM
17 process selection, providing an example of a high-level diagram and with section 6.8.2, specific process
18 considerations. However, additional standards may be needed to address trade-off criteria between
19 processes. ASTM F3488-22 addresses tradeoffs between processes.
22 Recommendation: Continue work to complement what has been published in ISO/ASTM 52910. Focus
23 on identification of trade-off criteria between processes. There is still a need to develop a standard for
24 reporting process inputs and capabilities.
25 Priority: ☐High; ☒Medium; ☐Low
26 Organization: National labs and government agencies for the R&D. ISO/TC 261 & ASTM F42 for the
27 standards work.

30 Repair; ☐Data


5 ☐Personnel/Suppliers; ☒Other (specify) Not Q&C Related
6 Current Alternative: Organizational level internal evaluations
7 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☒ Closed;
8 ☐New
9 V3 Update: ASTM F3488 was approved in 2022, which includes the pros/cons of each process per the
10 gap description above. Revisions currently underway on the ISO/ASTM 52910-18 version do not appear
11 to address the needs identified in this gap. An MIT tool is available to help identify the process (not for
12 design) and inform decision-making based upon user needs.
13 2.1.2.2 Process-Specific Guides for AM
14 ASTM and ISO plan to continue to jointly develop guidelines following the standards development
15 framework they have agreed to . Accordingly, process-specific design guidelines are beginning to be
16 developed. ISO/TC 261 and ASTM F42 have jointly developed technical design guidelines for laser-based
17 powder bed fusion (PBF-LB) for both metals (ISO/ASTM 52911-1), and polymers (ISO/ASTM 52911-2)
18 These are similar in concept to an existing German standard VDI 3405. Work is ongoing for electron
19 beam. There is another standard being contemplated on material extrusion. In addition, AWS is
20 developing D20.1 which will address directed energy deposition (DED) and PBF processes.
22  ASME PTB-13 – 2021; Criteria for Pressure Retaining Metallic Components Using Additive
23 Manufacturing provides guidance on the essential elements to be addressed in standards for the
24 construction of metallic pressure retaining equipment using powder bed fusion additive
25 manufacturing.
26  ASTM F3413-19e1, Guide for Additive Manufacturing — Design — Directed Energy Deposition
27 (F42.04)
28  ASTM F3529-21, Guide for Additive Manufacturing – Design – Material Extrusion of Polymers
29 (F42.04)
30  ASTM F3530-22, Standard Guide for Additive Manufacturing — Design — Post-Processing for
31 Metal PBF-LB (F42.04)
32  ISO/ASTM 52900:2021, Additive manufacturing — General principles — Fundamentals and
33 vocabulary
1  ISO/ASTM 52911-1-2019, Additive manufacturing — Design — Part 1: Laser-based powder bed
2 fusion of metals
3  ISO/ASTM 52911-2-2019, Additive manufacturing — Design — Part 2: Laser-based powder bed
4 fusion of polymers
5  ISO/ASTM 52911-3:2023, Additive manufacturing -- Design -- Part 3: PBF-EB of metallic materials
7  ASME Pressure Technology Book (PTB) for Additive Manufacturing Criteria Document for Direct
8 Energy Deposition.
9  ASTM WK69732, New Guide for Additive Manufacturing -- Wire Arc Additive Manufacturing
10 (F42.05)
11  ASTM WK83109, New Guide for Additive manufacturing -- Design -- Vat Photopolymerization
12 (F42.04)
13
14 Gap DE3: Process-Specific Design Guidelines. Develop AM process-specific design guidelines for binder
15 jetting (including shrinkage factor in final dimensions), material jetting, sheet lamination, and non-
16 polymer material extrusion as well as complete standards work for vat photopolymerization. The
17 objective is to have AM process-specific design guidelines for the 7 types of AM process identified by
18 ASTM and ISO.
19 R&D Needed: ☐Yes; ☐No; ☒Maybe
20 R&D Expectations: Not yet determined to fill the gaps on the remaining processes and related materials.
21 ASTM to complete WK83109 on vat photopolymerization.
22 Recommendation: Develop guidelines for the other AM processes defined in ISO/ASTM 52900:2021,
23 Additive manufacturing -- General principles – Fundamentals and vocabulary.
25 Organization: ASTM F42/ISO TC 261 JG 57, AWS

28 Repair; ☐Data

1 Q&C Category: ☐Materials; ☒Processes/Procedures; ☐Machines/Equipment; ☐Parts/Devices;
2 ☐Personnel/Suppliers; ☐Other (specify) ______________________
3 Current Alternative: Organizational level internal practices.
4 V3 Status of Progress: ☒Green (ISO/ASTM for vat-P); ☐Yellow; ☐Red; ☒Not Started for other processes
5 defined in ISO/ASTM 52900; ☐Unknown; ☐Withdrawn; ☐Closed; ☐New
6 V3 Update: Per above, the ISO/ASTM is addressing the PBF, directed energy deposition and material
7 extrusion for polymers. Work is underway on vat photopolymerization.
8 2.1.2.3 Design Guides for Specific Applications
9 Following the ASTM/ISO framework , the next generation of design guidelines are expected to be
10 application specific. Candidates for early application-specific guidelines include Design for Aerospace,
11 Design for Medical, Design for Automotive, etc. The current landscape suggests that such standards may
12 be developed by ASTM F42 and ISO/TC 261. ISO/TC 44/SC 14, Welding and brazing in aerospace, also
13 has formed a WG 1, Additive manufacturing in Aerospace. While this group is application-specific, the
14 design implications are unclear. Design guidelines are often manufacturer-specific.
15 ASTM subcommittee F42.07 on Applications develops sector specific AM standards for ten sectors
16 including aviation, spaceflight, medical/biological, transportation/heavy machinery, maritime,
17 electronics, constructions, oil/gas, consumer, and energy.
19  ASME PTB-13 – 2021; Criteria for Pressure Retaining Metallic Components Using Additive
20 Manufacturing, which covers powder bed, but not “traditional” arc welding processes This
21 provides guidance on the essential elements to be addressed in standards for the construction
22 of metallic pressure retaining equipment using powder bed fusion additive manufacturing.
23  ASTM F3456-22, Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for
24 Medical Applications for Additive Manufacturing Feedstock Materials (F42.07)
25  ASTM F3554-22, Standard Specification for Additive Manufacturing – Finished Part Properties –
26 Grade 4340 (UNS G43400) via Laser Beam Powder Bed Fusion for Transportation Applications
27 (F42.07)
28  ASTM F3572-22, Standard Practice for Additive Manufacturing – General Principles – Part
29 Classifications for Additive Manufactured Parts Used in Aviation (F42.07)
30  BPVC Code Case 3020, Qualification of Gas Metal Arc Manufacturing (GMAAM) Procedures
31 (approved 05/24/2021)
32  ISO/ASTM 52941-2020, Additive manufacturing — System performance and reliability —
33 Acceptance tests for laser metal powder-bed fusion machines for metallic materials for
34 aerospace application
35  ISO/ASTM 52942-2020, Additive manufacturing — Qualification principles — Qualifying machine
36 operators of laser metal powder bed fusion machines and equipment used in aerospace
37 applications
1  SAE ARP7042, Recommended Practice: Development Planning for Design of Additive
2 Manufactured Components in an Aircraft System (2022-03-02)
3  SAE ARP7043, Recommendations for an Additive Manufacturer Designing/Repairing Aircraft
4 Components (2022-08-05)
5
7  ASME Pressure Technology Book (PTB) for Additive Manufacturing Criteria Document for Direct
8 Energy Deposition.
9  ASTM WK81114, Standard Practice for Additive Manufacturing -- General Principles -- Design
10 Process of Additively Manufactured Building Elements (F42.07)
11
12 Gap DE4: Design Guides for Specific Applications. As industry fields mature in particular AM
13 applications, best practices should be recorded.
16 Recommendation: It is recommended that any application-specific design guides extend available

17 process-independent and process-specific design guides. However, application-specific design guidelines
18 may also need to be developed by their respective communities, and in such cases these guidelines may
19 fall under respective societies or SDOs. For instance, a design guideline for printed electronics may be
20 best suited for an organization such as IEEE or IPC.
21 Priority: ☐High; ☒Medium; ☐ Low
22 Organization: ASME, SAE, ASTM F42/ISO TC 261, and potentially other SDOs et al. (e.g., manufacturers,
23 industry consortia)

26 Repair; ☐Data

32 Q&C Category: ☐Materials; ☐Processes/Procedures; ☐Machines/Equipment; ☒Parts/Devices;

1 Current Alternative: Each industry sector is leveraging domain specific guidance.
2 V3 Status of Progress: ☒Green; ☐Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
3 ☐New
4 V3 Update: See text above.
5 2.1.2.4 Machine Customizable/Adaptive Guides for AM
6 Many manufacturers, including those of hobbyist machines as well as production machines, have begun
7 to provide guidelines to help in decision-making and process-planning for their specific machines (e.g.,
8 EOS, MakerBot documentation). Service providers have begun to provide design guidelines to help
9 customers better understand manufacturing constraints and better prepare designs before sending
10 them to a service provider to be manufactured (e.g., Xometry and documentation). The implications are
11 that guidelines and rules may become machine and implementation specific.
12 Gap DE5: Support for Customizable Guidelines. Producing the same part on different machines from
13 different manufacturers and often the same manufacturer will return different results. While process
14 and application guidelines will provide meaningful insight, additional tailoring may be needed for
15 specific instantiations. Methods that incorporate machine specific data into guidelines. For example,
16 how to use in-situ monitoring to better inform internal guidelines.
17 R&D Needed: ☒Yes; ☐No; ☐Maybe
18 R&D Expectations: Customizable guidelines require understanding process/machine/design

19 characteristics and subsequent tradeoffs. New monitoring techniques and data being generated which
20 support customizable design guidelines; applicable to various machines.
21 Recommendation: As machines are benchmarked and calibrated (see gap PC2), designers should have
22 mechanisms available to them that will provide operational constraints on their available AM processes.
23 Designers should understand what geometric and process liberties might be taken for their particular
24 implementation.
26 Organization: ISO/ASTM

29 Repair; ☒Data

3 Q&C Category: ☒Materials; ☒Processes/Procedures; ☒Machines/Equipment; ☐Parts/Devices;

5 Current Alternative: Internal guidelines.
6 V3 Status of Progress: ☐ Green; ☐Yellow; ☐Red; ☒Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
7 ☐New
8 V3 Update: ASTM WK54856, New Guide for Principles of Design Rules in Additive Manufacturing, has
9 been tabled. No other active standards projects are known at this time.
10 2.1.2.5 Design Guide for Post-processing
11 When designing a part for AM, often considerations must be taken for post-processing requirements.
12 These requirements include:
13 1. Surface Roughness/Fatigue: The surface roughness of parts is significantly greater when using
14 AM. This can be of significant concern for fatigue critical parts and gas or fluid flow in internal
15 passages for heat transfer and pressure drop effects. However, there are numerous third-party
16 finishing processes that can enhance this finish. These processes include, but are not limited to:
17 micro-machining, Isotropic Super Finishing, Drag Finishing, and laser micromachining. Since
18 material may be removed, the AM part might have to be designed oversized. However, there
19 are no standard design guides to assist the engineer in designing for this.
20 2. Design for Inspection: Though AM may enable more complex designs, the need for inspecting
21 critical features, including internal surfaces, should be considered in a part and build design. For
22 example, a poorly planned build or design may offset savings in fabrication by increasing the
23 resources needed to verify a part’s final dimensions. Including key pieces of geometry to allow
24 for easy datum identification in the printed part can reduce inspection costs.
25 3. Design for Post-processing Operations: Most parts will require some
26 post-processing (such as machining or heat treatment) after AM. This
27 is similar to castings and forging. Traditional post-processing methods
28 may not be applicable or may require tailoring to be suitable for AM
29 parts. However, design considerations to facilitate post processing for
30 AM parts can reduce overall program costs. This may include, a means
31 to fixture or index the part as well as ways to reduce or eliminate the
32 need for supports. As an example (shown in Figure 1), the Penn State
33 Applied Research Laboratory (ARL) and the Naval Air Warfare Center
34 (NAWC) at Lakehurst incorporated a means for indexing a drill into the
Figure 1: Hydraulic
35 design of a Hydraulic manifold. Also, incorporating fixture tabs and Manifold
36 "soft Jaws" in the printed part can facilitate manufacturing.
1 a. Has the design been optimized to reduce the need for support structure?
2 b. Has the design been optimized for unreacted liquid or unadhered powder to be able to
3 drain from internal cavities or lattices?
4 c. If required for post-machining operations such as drilling, has a means to facilitate
5 indexing been incorporated in the design?
6 d. Have considerations for the fixturing of the part during post processing been
7 incorporated in the design?
8 e. Has the part’s removal from the build platform been considered in the design, which
9 may include potential impacts from localized heating effects, kerf required by each
10 removal operation, clearance for cutting tools, and impacts from vibrations during the
11 cutting process?
12 f. Have the mechanical properties used for design of the AM part accounted for stress
13 relief, heat treatment, and HIP effects, such as minimizing part distortion, reducing
14 porosity, healing voids, and improved/controlled mechanical properties? (Depending on
15 the application, design mechanical properties may need to be validated in order to
16 complete qualification and certification of the AM part.)
17 4. Design for Heat Treatment: Designers need to understand how post-processing heat treatments
18 and stress relief can impact the material properties and the intent of the design. For example,
19 thermal post-processing may be used to remove residual stresses that could have resulted in
20 part distortion; heat treatments can be used to tailor and improve mechanical properties; and
21 HIP may reduce defects and porosity. Heat treatment methods that are standardized and
22 validated (through experimentation) need to be developed for AM and may be adapted from
23 “traditional” methods.
24 5. Design Parts for Safe AM Processing and Post-Processing: When designing parts and build plans
25 for fabrication by AM methods, safety must be considered for personnel operating the machines
26 and conducting post-processing tasks.
27 a. Parts should avoid trapped volumes which could trap unused liquid or powder build
28 materials (for some AM processes) creating potential safety hazards. Access features,
29 such as holes and slots, may be included to remove excess materials.
30 b. Solid supports are encouraged because they are stronger and safer.
31 c. If parts need to be cut from a build platform, the layout should be planned to reduce the
32 risk of breaking tools during the removal process.
33 d. Prior to printing, the build file and parameter sets should be reviewed to determine the
34 likelihood of a successful build and to assess the risk to the equipment from the build
35 file and parameters.
36 6. Design for Fasteners: Fused deposition modeling designs in additive manufacturing have
37 challenges interfacing with fasteners. Standards which address the print profile for printed
38 holes, design for countersunk fasteners, design for rivets; and guidance for addressing printed
39 threads, helicoils and heat set inserts are needed. An increased understanding about these
40 areas from stakeholders would help advance discussions about future standards development
41 and print design needs.
42
5 recommendations (ASTM F3154-18)
6  ASME B46.1-2019, Surface Texture (Surface Roughness, Waviness, and Lay)
7
9  ASME B46 Project Team (PT) 52: Additional work has begun on revisions for the next edition of
10 B46.1-2019 and further revisions are expected based on the work from PT 52.
11  ASTM WK66682, Guide for Evaluating Post-processing and Characterization Techniques for AM
12 Part Surfaces (F42.01)
13
14 Gap DE7: Design Guide for Post-processing. There is a need for additional design guides for post-
15 processing. Depending on the type of process used for post processing different practices may be used.
16
18 R&D Expectations: General research about post processing is needed, surface finishing and its
19 correlation to fatigue and fatigue requirements.
20 Recommendation: Continue work to develop a design guide(s) related to various AM processes,

21 materials, and applications for post processing.
23 Organization: ASME B46, ASTM F42/ISO TC 261
24 Lifecycle Area: ☒ Design; ☐Precursor Materials; ☐Process Control; ☒Post-processing; ☐Finished

26 Repair; ☐Data


1 Current Alternative: Depends on the process used for post-processing.
2 V3 Status of Progress: ☒Green; ☐Yellow; ☐Red; Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
3 ☐New
4 V3 Update: See text above. ASTM F3530-22 and ISO/ASTM 52910-18 has been published and includes a
5 high-level discussion of design considerations for post-processing but more detailed design guides
6 addressing specific AM processes, materials, and applications are needed.
7 ASME B46 Committee is working on measurement and characterization methods for AM surface finish
8 (not a design guide). The measurement and characterization methods that work for relating
9 performance for machined or ground finishes should not be expected to work for relating performance
10 for AM finishes. B46 explains how to find parameters that can describe the topography so they can
11 correlate and discriminate between processing and performance parameters.
12 2.1.2.6 Design of Lattice Structures
13 AM allows manufacturing of lattice structures layer-by-layer directly from a CAD model. Lattice
14 structures1 can be used for a wide range of applications and to integrate multiple functions into a
15 physical part. For example, in the medical sector lattice structures are designed to engineer material
16 properties and enhance biological cellular growth for better functioning of implants and to prevent
17 stress shielding. Off-the-shelf software can allow a designer to create a myriad of periodic cellular
18 structures and stochastic structures that replicate natural tissues. IEEE’s paper on Design of Lattice
19 Structure for Additive Manufacturing provides additional context on AM processes, design methods and
20 considerations, mechanical behavior, and applications for lattice structures enabled by this emerging
21 technology.
23  ANSI/AAMI/ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and

24 testing within a risk management process
25  ASME Y14.46-2022, Product Definition for Additive Manufacturing
26  ASTM F1160-14(2017)e1, Standard Test Method for Shear and Bending Fatigue Testing of
27 Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
28  ASTM F1854-15, Standard Test Method for Stereological Evaluation of Porous Coatings on
29 Medical Implants. Definition 4.4 discusses “tissue interface gradients” which would apply to
30 gradients for porous structure sizing. It is currently under revision per WK60654 and WK78770.
1
W. Tao and M. C. Leu, "Design of lattice structure for additive manufacturing," 2016 International Symposium on
Flexible Automation (ISFA), Cleveland, OH, USA, 2016, pp. 325-332, doi: 10.1109/ISFA.2016.7790182. Last accessed
April 4, 2023. https://ieeexplore.ieee.org/document/7790182
1  ASTM F2971-13(2021), Standard Practice for Reporting Data for Test Specimens Prepared by
2 Additive Manufacturing
3  ASTM F3122-14(2022), Standard Guide for Evaluating Mechanical Properties of Metal Materials
4 Made via Additive Manufacturing Processes
5  ASTM F3335-20, Standard Guide for Assessing the Removal of Additive Manufacturing Residues
6 in Medical Devices Fabricated by Powder Bed Fusion
7  ISO/ASTM 52901:2017, Standard Guide for Additive Manufacturing – General Principles –
8 Requirements for Purchased AM Parts
9  ISO/ASTM TR 52912:2020 Additive manufacturing — Design — Functionally graded additive
10 manufacturing
11  ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory
12 purposes
13  ISO 19227:2018, Implants for surgery - Cleanliness of orthopedic implants- General
14 requirements
15  ISO/TS 19930:2017, Guidance on aspects of a risk-based approach to assuring sterility of
16 terminally sterilized, single-use health care product that is unable to withstand processing to
17 achieve maximally a sterility assurance level of 10-6
18  FDA 21 CFR 820.70, Production and process controls
19  FDA's Design Control Guidance for Medical Device Manufacturers (relates to FDA 21 CFR 820.30
20 and Sub-clause 4.4 of ISO 9001)
21
23  ASTM WK76163, Standard Test Method for Additive Manufacturing -- Test Artifacts --
24 Compression Validation Coupons for Lattice Designs
25 Gap DE14: Designing to be Cleaned. Currently there are no design guidelines for devices to assure
26 cleanability post-production. When designing a device (including medical), cleanability must be
27 evaluated at different stages for a number of reasons:
28 1. Manufacturing residues/contact materials encountered during the manufacturing process will be

29 removed (see Gap DE7: Design Guide for Post-processing).
30 2. Unmelted/unsintered AM material from the manufacturing process will be removed (see Gap DE7:
31 Design Guide for Post-processing).
32 3. For devices that are to be sterilized prior to use, a sterilization test soil can be placed at the most
33 difficult location to sterilize so that the validation will accurately show if foreign bodies picked up
34 during the manufacturing process can either be killed or removed from the device prior to
35 sterilization
36 4. For reusable devices, a device may need to be adequately cleaned and sterilized prior to
37 subsequent uses
38 5. For reusable devices, the device materials may need to be maintained for the specified number of
39 cleaning cycles
1
2 For medical devices, there may be more specific sterilization needs. This is more directly related to post-
3 processing and testing related aspect and less related to AM design. The need identified within this gap
4 is not solely related to medical. Regarding #4 and #5 above, requirements exist for reprocessing medical
5 devices.
7 R&D Expectations: In terms of ways to determine what parts are likely to be cleanable before they are
8 made, AM technology and material specific needs exist. Per #3 above, research on sterilization
9 validation for where you place the soil is needed.
10 Recommendation: Develop design guidance within existing published design guidelines to provide
11 general design limits and recommendations that achieve both needed surface structure and allow
12 adequate cleaning. A separate standard may not be needed. See also gap FMP3 and gap QC15.
14 Organization: AAMI, ASTM F04, ASTM F42/ISO TC 261, ISO/TC 198, ASME (surface metrology), FDA

17 Repair; ☐Data


25 Current Alternative: Vendors will specify the needs and internal design practices will be leveraged.
26 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☒Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
27 ☐New
28 V3 Update: AAMI and ASTM have an interest and are meeting. FDA is also looking at this.
1 2.1.2.7 Design of Test Coupons
2 Test coupons have very specific uses in manufacturing but are not always the appropriate way to
3 evaluate a part or sample and cannot replace a robust process validation. In specific circumstances
4 when a feature can be effectively isolated and still represent the whole part, they can be useful tools as
5 an over check for the process. For example, the use of test coupons to determine the capability and
6 repeatability of the manufacturing process to make porous structures may be useful. In addition, surface
7 topography including at the nanoscale could impact the testing procedures. It may not be necessary to
8 design test coupons for each production lot.

11  ISO/ASTM TR 52912:2020 Additive manufacturing — Design — Functionally graded additive
12 manufacturing
13
15  ASTM WK76163, Standard Test Method for Additive Manufacturing -- Test Artifacts --
16 Compression Validation Coupons for Lattice Designs
17 Gap DE15: Design of Test Coupons. No AM standards are currently available for the design of test
18 coupons for additively-manufactured structures. There may be application specific needs, which would
19 focus on application specific related stresses. While there are many methods, they are not design
20 related and they would need to be revised for this purpose. Test methods may need to be developed
21 first.
23 R&D Expectations: Effects on what is in the build and how well can you replicate your feature of
24 interest.
25 Recommendation: Develop standard application specific test methods and specifications for the design
26 of test coupons for additively-manufactured porous structures.
27 Priority: ☒High; ☐Medium; ☐Low
28 Organization: ASTM F04 and F42, ISO TC 261

30 Material Properties; ☒Qualification & Certification; ☐Nondestructive Evaluation; ☐Maintenance and
31 Repair; ☐Data

4 Q&C Category: ☒Materials; ☐Processes/Procedures; ☐Machines/Equipment; ☐Parts/Devices;

6 Current Alternative: Standard coupons are being used
8 ☐New
9 V3 Update: ASTM F42 is working on standards for the compression test and test coupons. Also, ASTM
10 F04 is looking at this. ASME V&V 40 Subcommittee on Verification and Validation in Computational
11 Modeling of Medical Devices is working to form a working group on this item.
12
13 Gap DE16: Verifying Functionally Graded Materials (FGM). Functionally graded materials are materials
14 with variation in the composition or structure in order to vary the material properties (e.g., stiffness,
15 density, thermal conductivity, etc.). Standard methods of specifying and verifying functionally graded
16 materials currently do not exist. Furthermore, existing test methods may be leveraged or need to be
17 modified to address considerations when validating their performance.
19 R&D Expectations: Characterizing the functional grades in a way that can be specified and measured
20 and integrating solutions into other design and software tools.
21 Recommendation: Update existing test guidelines for metals and polymers with considerations for
22 materials that have graded properties. If the grade itself needs to be verified versus only its
23 performance, new test methods may be needed. This is a broad topic however and depends on what is
24 being evaluated.
26 Organization: ASTM F04 and F42, SAE AMS-AM, ASME, ISO/TC 261 JG 67

29 Repair; ☐Data

4 Q&C Category: ☒Materials; ☒Processes/Procedures; ☐Machines/Equipment; ☐Parts/Devices;

6 Current Alternative: Unknown
7 V3 Status of Progress: ☐Green; ☒Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
8 ☐New
9 V3 Update: ASME Y14.46 discusses the specification of functionally graded materials. New efforts are
10 focusing on verification of lattice FGM specifications. ISO/ASTM TR 52912:2020, Additive manufacturing
11 — Design — Functionally graded additive manufacturing was published as a technical report that
12 addresses design opportunities and challenges of functionally graded materials.
13 2.1.3 Design Tools

14 A wide range of tools are commonly used in the design process to exploit AM design opportunities not
15 afforded by traditional manufacturing processes. Some of the new challenges and requirements
16 imposed by AM on design tools that did not exist in traditional manufacturing are described below.
17 2.1.3.1 A Machine Input and Capability Report
18 Since different AM processes have different design requirements, manufacturing requirements, and
19 manufacturing capabilities (e.g., overhang angles, minimum member thickness, minimum hole diameter,
20 etc.), it is often challenging to determine if a design is feasible for a given AM process. Ideally, machine
21 inputs (e.g., tool paths, processing parameters, rate, etc.) and capabilities necessary for design tools to
22 ISO/ASTM 52915:2020 standard specification for AMF file format includes support for 15 specific meta
23 data types, plus a general meta data field that can include additional printing parameters and machine
24 capabilities. This capability can currently support the recommended requirements by defining each new
25 meta data naming convention and range of values/categories, etc. and adding this to the list of current
26 meta data types to an update to this standard (v1.3), which is currently in the planning stage in ISO
27 TC261.assess feasibility would be standardized. Current meta data defined includes: unit of measure,
28 tolerance, material(s), color(s), design file ID, version number, description, designer, company, reference
29 URL, etc. Specific meta data can be applied to individual components within the object, the entire object
30 or an assembly of objects, each with separately defined location and orientation.
31 The URL meta data element provides a simple and reliable way to link additional detailed information to
32 the file, such as a technical data package, IP notifications, and specific system requirements, while
33 providing the potential for secure access to all this information to authorized users only. This is also
1 applicable to addressing a significant portion of gap DE20 on a “neutral build format”. By defining all
2 necessary and appropriate printing requirements and parameters as meta data elements that can be
3 expressed in XML v1.0 in list format, the designer can provide as much design information and machine
4 specific requirements as they want, all integrated within the 3D mesh file, and/or accessed via the
5 embedded URL to provide, for a complete data package.
7  ASTM F3490-21, Standard Practice for Additive Manufacturing — General Principles — Overview
8 of Data Pedigree (F42.08)
9  ISO/ASTM 52915:2020, Specification for additive manufacturing file format (AMF) Version 1.2
10 (2020-03)
11  Printer Working Group, PWG 3D Print Job Ticket and Associated Capabilities v1.0 (PJT3D) (2017-
12 08-18)
13  Printer Working Group, PWG 5100.21-2019: IPP 3D Printing Extensions v1.1 (2019-03-29)
15  Printer Working Group, IPP 3D Production Printing Extensions v1.0 (3DPPX) (wd-ipp3dppx-
16 yyymmdd) defines a new specification that updates IPP 3D Printing Extensions v1.1 (PWG
17 5100.21-2019) for 3D production-level features
18
19 Gap DE8: Machine Input and Capability Report. A standard for reporting machine input requirements
20 and the associated AM machine capabilities is required to support new design tools which will be able to
21 determine manufacturing feasibility, optimize manufacturing solutions, and identify AM equipment
22 which would be able to manufacture the part.
24 R&D Expectations: To be determined.
25 Recommendation: Develop a standard for reporting machine inputs such as printing parameters, laser
26 track, etc. and machine capabilities such as dimensional accuracy, surface finish, material properties,
27 geometry constraints (over hang angle requirements), size, porosity, etc. These reports would be used
28 by software to accomplish the following:
29 1. Topology Optimization
30 2. Optimize manufacturing solutions
31 3. Identification of suitable AM equipment
32 4. Build Simulation
33 5. Lattice structure generation
34 6. Spatial comparisons (e.g., common standard grid)
35 See also gap DE20 on neutral build format.
2 Organization: 3MF, Consortium of industry, ISO/ASTM, IEEE-ISTO PWG, IPP

5 Repair; ☒ Data

11 Q&C Category: ☐Materials; ☐Processes/Procedures; ☒Machines/Equipment; ☐Parts/Devices;

13 Current Alternative: Proprietary tools and process documentation as well as ISO/ASTM 52915:2020.
15 ☐New
16 V3 Update: See standards activities above.
17 2.1.3.2 A Requirement for an AM Simulation Benchmark Model/Part
18 AM process simulation tools are becoming an important aspect of the AM design process by enabling
19 the designer to predict consequences of material and process parameter choices on objective
20 fabrication or part qualities. These simulations are used (but not limited to) predict microstructural
21 evolution and properties, identify optimal process parameters to enable high density parts, or predict
22 and mitigate residual stress and process dependent deformation. Residual stress and distortion
23 prediction tools are currently at the highest technology readiness level (TRL). There is a growing list of
24 commercially-available simulation tools, internally-developed or proprietary tools in industry, some
25 open-source tools, and many academic examples under development. Standard for an AM benchmark
26 model(s)/part(s) to validate these simulation tools would benefit end users.
27 ASME VVUQ 50 Verification, Validation, and Uncertainty Quantification of Computational Modeling for
28 Advanced Manufacturing is creating standards to provide procedures for verification, validation, and
29 uncertainty quantification in modeling and computational simulation for advanced manufacturing.
30 While VVUQ 50 has not yet published standards specific to manufacturing processes, other VVUQ
31 standards such as ASME VVUQ 10 or VVUQ 20 have applicable guidelines.
1 In 2020 NASA, NIST, and FAA held the Technical Interchange Meeting on Computational Materials
2 Approaches for Qualification by Analysis for Aerospace Applications. A workshop report from this
3 meeting identifies critical R&D necessary to further develop AM computational simulation technologies
4 and gaps for their use in qualification and certification framework. Members of NASA, NIST, and FAA
5 created the Computational Materials for Qualification and Certification (CM4QC) steering group to
6 coordinate efforts towards goals identified in the workshop.
8  NIST Additive Manufacturing Benchmark Test Series (AM-Bench) and associated datasets.
9  ASME VVUQ 1-2022 Verification, Validation, and Uncertainty Quantification Terminology in
10 Computational Modeling and Simulation
11  ASME V V 10-2019 Standard for Verification and Validation in Computational Solid Mechanics
12  ASME V V 20-2009 (R2021) Standard for Verification and Validation in Computational Fluid
13 Dynamics and Heat Transfer
14  ISO/ASTM 52902-19 Additive manufacturing -- Test artifacts -- Geometric capability assessment
15 of additive manufacturing systems
16
17 Gap DE9: AM Simulation Benchmark Model/Part Requirement. Standards for process and simulation
18 type-specific AM benchmark models, tests, and/or parts are needed to enable verification and validation
19 (V&V) of applicable process simulation tools.
20 R&D Needed: ☒Yes; ☐No; ☐Maybe.
21 R&D Expectations: R&D is needed to identify proper testing and measurement procedures to evaluate
22 the predictive accuracy of simulations, and determine to what extent a simulation ‘validated’ through
23 controlled physical tests/measurements may be extensible to alternate part designs. Quantitative (i.e.
24 statistical) metrics need to be defined to appropriately assess model to measurement accuracy and
25 uncertainty. R&D is also needed for development of many computational simulations themselves, with
26 the scale/amount of R&D depending on the simulation type and complexity, and the need for standards
27 rising with the availability of more complex simulation tools.
28 Recommendation: Develop a set of standardized physical tests (e.g., test artifacts and required controls)
29 and associated measurements that 1) can be quantitatively related to simulation outputs and 2) target
30 or align with the technical objectives of the simulations (e.g., distortion prediction). Develop guidelines
31 and/or metrics for quantifying the accuracy of the models considering measurement uncertainty and
32 model uncertainty, and extensibility to alternate part designs from the validation tests.
33 Priority: ☒High; ☐Medium; ☐ Low
34 Organization: NIST, America Makes, ASME V&V 50, ISO/ASTM, AFRL
1 Lifecycle Area: ☒Design; ☒Precursor Materials; ☒Process Control; ☒Post-processing; ☒Finished
2 Material Properties; ☒Qualification & Certification; ☒Nondestructive Evaluation; ☐Maintenance and
3 Repair; ☒Data

9 Q&C Category: ☒Materials; ☒Processes/Procedures; ☐Machines/Equipment; ☒Parts/Devices;

11 Current Alternative: Stakeholders are generating data to validate models (i.e. NIST, AFRL).
13 ☐New
14 V3 Update: The 2nd AM Bench test series led by NIST occurred in 2022, and measurement results
15 database is being populated and organized. ASME VVUQ 50 is developing VVUQ methods for advanced
16 manufacturing, including additive. NASA, NIST, and FAA held the Technical Interchange Meeting on
17 Computational Materials Approaches for Qualification by Analysis for Aerospace Applications in 2020.
18 2.1.3.3 Standardized Design for Additive Manufacturing (DFAM) Process Chain
19 Additive manufacturing seamlessly connects product design in a virtual environment with rapid
20 manufacturing in the physical domain. It is a unique advantage and natural extension of design for
21 additive manufacturing to fully leverage the power of digitalization to automatically and systematically
22 enable AM potential in product development. To do so, a standardized DFAM process chain needs to be
23 established that delineates and integrates key AM considerations and design tools in the complete
24 product design process.
25 The industrial product development process can be segmented into the following generic stages:
26 Requirements Study/Specifications, Conceptual Design, Preliminary Design, and Detail Design. Each
27 stage has unique requirements and needs for AM, and therefore demands for particular AM
28 considerations and dedicated design tools. Examples include topology optimization in Preliminary
29 Design exploration, AM checkers/cost estimation in Preliminary and Detail Design, etc. A standardized
30 design for AM process chain would need to define entry points at each design stage to insert the
31 corresponding AM considerations/design tools. It would need to provide a logical, intuitive, and
32 systematic framework for maximizing the use of AM in product development. Such a process chain may
1 be represented as activity diagrams at a high level. With the additional handling of data/tool interfacing,
2 the process chain can be fully digitalized.
3 The gap that follows identifies a need to expand standardization of the complete DFAM process chain.
4 DFAM would need to fit in with higher level topics (beyond the scope of this document) such as
5 Advanced Manufacturing, Digital Twin, and Digital Thread.
6 Work is being done across many aspects of the DFAM process chain across industry, academia, the
7 Government, and professional organizations. There are leaders (automotive, aerospace, medical) and
8 CAE/CAD/CAM software that should be involved with developing DFAM process chain standards.
10  ISO/ASTM 52910-18, Additive Manufacturing – Design – Requirements, guidelines and

11 recommendations provides guidance on areas for a designer to consider when designing a part
12 for AM. Paragraph 6.2.6 states that a suitable process chain may be needed and focuses on
13 finish and accuracy of the AM part.
15  NIST AM materials database, though not dealing with process chain per se, will aid in developing
16 AM process chain.
19
21 ISO/TC 261 and ASTM F42 JG 73 is a Joint Group developing guidelines related to digital data
22 configuration control, data integrity checks, and enterprise work flow for files used in the metal PBF
23 process. The guideline covers digital product data workflows, file formats used for printing, automated
24 and manual methods for receiving digital data and build cycle information in the PBF process that can be
25 used for product quality assurance.2 The guidelines cover saving and storing the build cycle data in order
26 to meet quality system requirements. See also:
27  ISO/ASTM DIS 52910 Additive manufacturing — Design — Requirements, guidelines and

28 recommendations
29  ISO/ASTM PWI 52951, Additive manufacturing — Data packages for AM parts will address file
30 formats and the integration and preservation of information across the process chain.
31
2
See Shaw C. Feng, Paul Witherell, Gaurav Ameta, Duck Bong Kim, (2017) "Activity model for homogenization of
data sets in laser-based powder bed fusion", Rapid Prototyping Journal, Vol. 23 Issue: 1, pp.137-148,
https://doi.org/10.1108/RPJ-11-2015-0160
Gap DE27: Standardized Design for Additive Manufacturing (DFAM) Process Chain. A standardized
design methodology is needed for AM process chain integrating key AM considerations/design tools
in each design stage. A standard to address all the stages of a process chain from where the design
input would begin (including original or re-design designed part) is needed.
R&D Needed: ☐Yes; ☐No; ☒Maybe
R&D Expectations: TBD
Recommendation: Develop a standardized design for AM process chain that specifies and integrates
the key AM considerations and suggested design tools in each generic design stage. The process chain
can be expanded from ISO/ASTM 52910-18, Additive manufacturing — Design — Requirements,
guidelines and recommendations stages and complimented with design tools to address specific AM
needs for each task within the stages. The standardized design for AM process chain can be used by
various industries to roll out site-specific DFAM process and digitalization implementation.
Priority: ☐High; ☒Medium; ☐Low
Organization: ASTM F42/ISO TC 261 JG 73, NIST
Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished

Material Properties; ☐Qualification & Certification; ☐Nondestructive Evaluation; ☐Maintenance and
Repair; ☐Data
Sectors: ☒All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☐Electronics;

☐Energy; ☐Medical; ☒Spaceflight; ☐Other (specify) ______________________
Material Type: ☒All/Material Agnostic; ☐Metal; ☐Polymer; ☐Ceramic; ☐Composite
Process Category: ☒All/Process Agnostic; ☐Binder Jetting; ☐Directed Energy Deposition; ☐Material
Extrusion; ☐Material Jetting; ☐Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photopolymerization
Q&C Category: ☐Materials; ☒Processes/Procedures; ☐Machines/Equipment; ☐Parts/Devices;

☐Personnel/Suppliers; ☐Other (specify) ______________________
Current Alternative: None specified.
V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☒Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
☐New
V3 Update: Design processes could be sector/agency specific. See standards activities above.
1 2.1.4 Design for Specific Applications
2 AM has continued to expand throughout industry creating new opportunities in many sectors such as
3 medical and electronics. Consequently, in addition to general standards assisting with design for AM,
4 specific AM applications will also require standards.
5 2.1.4.1 Design for As-built Assembly
6 For purposes of this roadmap, “design for as-built assembly” is the ability to create, in a single build, a
7 functioning assembly composed of multiple parts that have relative linear or rotational motion between
8 the parts. This eliminates the process of having to assemble multiple parts into one functioning
9 assembly so that no assembly is required afterwards. AM assemblies built in this fashion range from
10 simple tools such as the NASA wrench3 to complex assemblies with gears and other moving parts. The
11 ability to create a functioning assembly in one build can lead to new and innovative assemblies not
12 possible with traditional manufacturing methods.
13 AM design for as-built assembly shares all of the requirements that traditionally built assemblies have
14 for individual part tolerances, assembly tolerance stack-up analysis, and surface finish to ensure the
15 operational objectives and design intent of the assembled parts is obtained. In addition, AM design for
16 as-built assembly needs to consider the removal of excess build material between parts in the assembly
17 and non-contact measurement and inspection methods to verify tolerances and surface finish to ensure
18 proper operation of an assembly. These issues are also common to individual AM parts. For example,
19 the excess build material for an AM part with internal cooling channels needs to be removed from the
20 channels, and non-contact inspection is necessary to verify inaccessible features.
21 Similar to conventional manufacturing, functional requirements for AM design for as-built assembly also
22 depend on how the assembly is used. The NASA wrench, built with material extrusion, might not require
23 tight tolerances to function properly. It may only be used a few times. Conversely, an AM assembly of
24 gears built with metal PBF might have to carry high loads and endure many usage cycles.

27  ISO 8887-1:2017, Technical product documentation - Design for manufacturing, disassembling
28 and end-of-life processing - Part 1: General concepts and requirements
29  ISO/ASTM 52915:2020, Specification for additive manufacturing file format (AMF) Version 1.2,
30 supports assembly multi-mesh definition, location and orientation. It also supports meta data
31 fields at component level and assembly level to specify some essential meta data, and it
32 supports inclusion of additional meta data, but lacks defined schema for all meta data described
33 in the gap
3
http://nasa3d.arc.nasa.gov/detail/wrench-mis
1
2 AM standards related to individual AM parts will also apply to parts in an assembly.
3 Gap DE10: Design for As-built Assembly. Guidelines do not exist for AM design for as-built assembly
4 which is the ability of an AM process to create an assembly with multiple parts with relative motion
5 capabilities in a single build. Design for Manufacture and Assembly (DFMA) practices do not account for
6 considerations of single build AM assemblies and assemblies constructed from individual AM parts.
7 Design approaches and additional design parameters (meta data) may need to account for complexity of
8 support structures, removal times, post-processing complexity, and manufacturing time/quality using
9 different parameter sets. In regard to parameters sets, factors of interest could include feed rate and
10 diameters for Directed Energy Deposition (DED), layer thickness and laser scan speed for PBF.
11 Furthermore, how these all factors interact must also be considered.
13 R&D Expectations: Additional research is needed related to individual AM part definition, including
14 tolerances, and non-contact measurement and inspection methods for AM assemblies. If AM design for
15 as-built assembly is to become a viable alternative for creating functioning assemblies, there needs to
16 be rigorous academic research, practical pilot projects, and real industry use cases. These are critical
17 elements in identifying the gaps that will result in the tailoring of existing standards and the
18 development of new standards for AM design for as-built assembly.
19 Recommendation: ISO 8887-1:2017, ISO/ASTM 52915:2020 and other DFMA standards can be reviewed
20 and further developed to address AM related issues.
21 Priority: ☐High; ☐Medium; ☒Low
22 Organization: R&D: Academia, industry, national laboratories. Standards: DoD, ISO, ASME, ASTM, AAMI,
23 NEMA/MITA

26 Repair; ☐Data

31 Extrusion; ☐Material Jetting; ☒Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photopolymerization

1 Current Alternative: Unknown, as-built assembly is not common because guidance does not currently
2 exist.
4 ☐New
5 V3 Update: ASME Y14.46 was revised in 2022 and ISO/ASTM 52915 was published in 2020 however the
6 gap is still considered open.
7 2.1.4.2 Design for Printed Electronics
8 The main effort in developing design standards for printed electronics is being led by the D-61a Flexible
9 Printed Electronics Design Standard Task Group out of IPC, which is the industry leading standards
10 organization in electronics manufacture. The main document is IPC-2292, Design Standard for Printed
11 Electronics on Flexible Substrates (Rev A 2022-11-28), which establishes the specific requirements for
12 the design of printed electronic applications and their forms of component mounting and
13 interconnecting structures on flexible substrates. Flexible substrates, as pertaining to IPC-2292 are
14 materials, devices or functionalized circuitry which have some amount of flexibility or bendability (not
15 rigid) but are not considered to be stretchable. This standard may be used in conjunction with IPC
16 2221B-2012, Generic Standard on Printed Board Design (2012-11-20) and IPC 2223E-2020, Sectional
17 Design Standard for Flexible Printed Boards (2020-01-24) when printing on flexible printed circuit boards
18 (copper flex). The D-61a Task Group works in tandem with other IPC printed electronics task groups
19 under the D-62, Base Material/Substrates; D-63, Functional Materials; D-64, Final Assembly; and D-65,
20 Test Method Development and Validation Subcommittees for Printed Electronics. The task group also
21 works with the D-73a E-Textiles Printed Electronics Design Standard Task Group which developed IPC-
22 8952-2022, Design Standard for Printed Electronics on Coated or Treated Textiles and E-Textiles. IPC-
23 8952 establishes specific requirements for the design of printed electronic applications and their forms
24 of component mounting and interconnecting structures on coated or treated textile substrates. Textile
25 substrate, as pertains to this standard, could be a bare textile or an integrated e-textile (e.g., woven or
26 knitted e-textile). Coated or treated textile substrates, as pertain to this standard, are textile substrates
27 which have or will have a coating or treatment localized or across the full substrate. See also roadmap
28 section 1.5.6.
29 Gap DE11: Design for 3D Printed Electronics. There is a need to develop standards on design for 3D
30 printed electronics, including flexible and rigid substrates.
33 Recommendation: Complete work on IPC-2292, develop standard for 3D based on IPC-2292

34 requirements
1 Organization: IPC

4 Repair; ☐Data
5 Sectors: ☒All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☒Electronics;


12 Current Alternative: None specified.
14 ☐New
15 V3 Update: IPC 2292 was published in March 2018 and revised in November 2022 but does not address
16 this gap. With respect to the development of a design standard like IPC-2292, the group is of the view
17 that it is far too early in the maturation of this technology to develop design requirements, but they will
18 revisit this topic at future meetings. See also gap DE4.
19 2.1.4.3 Design for Medical
20 AM has caused a revolution in healthcare delivery. New medical devices embody the true meaning of
21 personalized medicine. Medical device designers and practitioners can practically and efficiently create
22 devices that were very difficult or impossible to create before. In addition to using AM to create
23 standard medical devices with features like intricate lattice structures, clinicians and engineers work in
24 conjunction to produce what are known as patient-specific or patient-matched devices. These are
25 medical devices designed to fit a specific patient’s anatomy, typically using medical imaging from that
26 patient. Anatomically matched devices have very complex geometrical contours and shapes. Several
27 challenges exist in the design process between the input data and the final device design. While the gaps
28 described below are tailored to medical specific concerns, the general community may have similar
29 concerns.
30 Many groups, including the FDA, have used AM techniques to create reference parts that mimic natural
31 anatomic shape and imaging properties (e.g., radiopacity, conductivity). These biomimetic designs have
32 advantages over geometric grids and patterns because they are more representative of a patient and
33 the real-world imaging capacity rather than the idealized geometric grids.
1 For pharmaceutical drug printing, shape flaws may be unimportant, but distribution (of active ingredient
2 across both halves) and particle size (for how fast it dissolves to deliver drug) are crucial. The U.S.
3 Pharmacopeia chapter 1119 for Near-Infrared (NIR) Spectroscopy4 would be useful for AM. The FDA
4 developed a discussion paper5 which presents areas associated with Distributed Manufacturing (DM)
5 and Point-of-Care (POC) manufacturing that FDA has identified for consideration as FDA evaluates our
6 existing risk-based regulatory framework as it applies to these technologies.
7 Input Data (CT, MRI, Ultrasound scan and X-Ray)
9  ISO/ASTM TR 52916:2022, Additive manufacturing for medical — Data — Optimized medical

10 image data
11  ISO/IEC 23510:2021, Information technology — 3D printing and scanning — Framework for an
12 Additive Manufacturing Service Platform (AMSP)
13
15 ISO/IEC JTC1/WG12 for “3D Printing and Scanning” has been established and is working on the
16 following:
17  Information Technology— Requirements of Image Processing for covering cranial defect
18  ISO/IEC FDIS 3532-1, Information technology – Medical image-based modelling for 3D Printing –
19 Part 1: General requirements (ISO/IEC JTC 1)
20  ISO/IEC DIS 3532-2, Information technology – Medical image-based modelling for 3D Printing –
21 Part 2: Segmentation (ISO/IEC JTC 1)
22
23 Gap DE12: Imaging Consistency. There are currently no standard best practices for creation of protocols
24 and validation procedures to ensure that medical imaging data can be consistently and accurately
25 transformed into a 3D printed object. Individual companies have developed internal best practices,
26 training programs and site qualification procedures. The details of a device’s individual imaging and
27 validation plan is developed specifically for each process or product. However, a set of consensus best
28 practices for developing these plans and key validation metrics could reduce the overhead in developing
29 them and reduce the burden on imaging sites. This framework should rely on input from clinical experts
30 to ensure that it accounts for and defers to clinical best practices where appropriate.
4
http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1119.html
5
U.S. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). 2022. FDA Distributed
Manufacturing and Point-of-Care Manufacturing of Drugs, Discussion Paper, Silver Spring, MD.: Food and Drug
Administration.
1 R&D Expectations: N/A; The information is housed within individual institutions and could be combined
2 through participation in clinical associations, consortiums or standards development organizations.
3 Recommendation: Develop a set of best practices for the development and qualification of imaging
4 protocols and imaging sites that provide inputs to patient-matched devices. The focus should be on
5 validation metrics and standard reference parts (phantoms) that can either be simple geometric
6 patterns, or more appropriately designed to mimic the shape and density of natural anatomy so that the
7 fidelity of an imaging sequence can be measured and calibrated. See also gaps QC7, QC9, QC14.
9 Organization: RSNA (Radiological Society of North America), ASTM F42/ISO TC 261 JG 70
10 Lifecycle Area: ☒Design; ☐Precursor Materials; ☒Process Control; ☐Post-processing; ☐Finished

12 Repair; ☐Data
13 Sectors: ☐All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☐Electronics;

14 ☐Energy; ☒Medical; ☐Spaceflight; ☐Other (specify) ______________________
18 Q&C Category: ☐Materials; ☒Processes/Procedures; ☒Machines/Equipment; ☐Parts/Devices;

19 ☒Personnel/Suppliers; ☐Other (specify) ______________________
22 ☐New
23 V3 Update: An RSNA 3D Special Interest Group (SIG) is working on best practices, not a standard.
24 ISO/ASTM TR 52916:2022 Additive manufacturing for medical — Data — Optimized medical image data
25 from ISO/TC 261 JG 70 deals with imaging quality. This is a secondary priority for the DICOM WG.
26 Data Processing
27 Gap DE13: Image Processing and 2D to 3D Conversion. Data acquired as a stack of 2D images is
28 converted to a 3D model that could be a device by itself or be a template to build the device on. Tissues
29 such as bone, soft tissue and vascular structures are isolated by the process of segmentation. Variability
30 of the output depends on factors such as spatial and grey scale resolution of the images which in turn
31 are driven by other factors such as the x-ray dosage, MRI protocol, operator capability, and
1 reconstruction algorithms. Computational modeling groups, software developers, research laboratories,
2 and the FDA have investigated methods of validating segmentation processes. However, the wide
3 variety of patient geometries, frequent inability to identify a ground truth due to imaging constraints,
4 and variability in the manual aspects of imaging have caused validation procedures to be developed by
5 individual entities.
7 R&D Expectations: Data to develop protocols exists but there is still a need for standardized,
8 physiologically relevant imaging phantoms that can be used to challenge many segmentation
9 techniques. Round robin testing for biomimetic imaging phantoms to validate segmentation techniques
10 for a test method is highly recommended. See also gap QC14.
11 Recommendation: 1) Develop a standard test method to use biomimetic imaging phantoms to validate
12 a segmentation technique. Round robin testing of this type of test method is highly recommended. Best
13 practices may include capturing enough information to set accurate threshold values and understand
14 geometric norms for a data set of interest. 2) Develop training standards that operators must meet to
15 ensure that they are able to adequately reproduce a validated image processing pipeline.
17 Organization: Methods: NEMA/MITA, ASME V&V 40, ASTM F4, ASTM F42/ISO TC 261. Phantoms: NIH,
18 NIST, FDA, RSNA

21 Repair; ☒Data


31 ☐New
1 V3 Update: On the R&D side, FDA research groups are developing phantoms but haven't yet interfaced
2 with SDOs. On the standards side, ISO/ASTM TR 52916:2022 Additive manufacturing for medical — Data
3 — Optimized medical image data from ISO/TC 261 JG 70 covers this gap. An RSNA SIG is also looking at
4 this.
5 3D Modeling
6 The initial 3D model is post-processed creating a model that becomes the input data, a template for the
7 design of the final device, or the device itself. During this process of data deletion, shape detection,
8 smoothening, and texturing functions are used to arrive at the final part to be manufactured.
9 The IEEE EMB Standards Committee has the P3333.2 Working Group for Standards Projects in Medical
10 3D Printed & Virtual Reality Models which is working on several projects including:
11  IEEE P3333.2.2, Standard for Three-Dimensional (3D) Medical Visualization
12  IEEE P3333.2.3, Standard for Three-Dimensional (3D) Medical Data Management
13  IEEE P3333.2.4, Standard for Three-Dimensional (3D) Medical Simulation
14  IEEE P3333.2.5, Standard for Bio-CAD File Format for Medical Three-Dimensional (3D) Printing
15  IEEE P3333.2.5.1, Standard for Soft Tissue Modeling for Medical 3D Printing
16  IEEE P3333.2.5.2, Standard for Hard Tissue Modeling for 3D Printing
17  IEEE P3333.2.5.3, Standard for Surgical Guide Design Modeling for Medical 3D Printing
18  IEEE P3333.2.5.4, Standard for Artificial Joint Implant Design Modeling for Medical 3D Printing
19  IEEE P3333.2.5.5, Standard for In Vivo Evaluation of 3D Printed Polymeric scaffolds in bone
20 defects
22  IEEE P3333.2.1-2015, Recommended Practice for Three-Dimensional (3D) Medical Modeling
23 In AMSC Roadmap version 2.0, gaps DE14, DE15, and DE16 focused on medical were incorporated here.
24 For this version, the gaps were moved to the Design Guides section of the chapter because the needs
25 identified by these gaps are currently considered applicable to additional sectors beyond the medical
26 sector.
27 2.1.5 Design Documentation

28 In most cases, upon completion of an engineering design, there will be a requirement to completely
29 document it. This requirement exists for many reasons. These include quality assurance requirements
30 following manufacture, in service engineering needs following fielding equipment, legal requirements,
31 as well as many other reasons. Traditionally, most engineering designs have been done with 2D
32 drawings constructed in accordance with ASME Y14.100-2017, Engineering Drawing Practices and
33 documented in a technical data package. However, AM offers the capability to create new designs that
34 were never conceived of before. These include new geometries such as gradient structures, intentionally
35 designed porosity, a means to modify material properties through track laser paths, as well as many
36 other new capabilities. Consequently, new standards are required to assist in the documentation of
1 these designs. ASME Y14.46 and ASTM/ ISO JG 73 will aim to address aspects of the product data
2 package for AM.
3
4 Some new challenges and requirements imposed by AM that did not exist in traditional manufacturing
5 are described below.
6
7 2.1.5.1 Data Package Content
8 Data Packages, sometimes referred to as technical data packages (TDPs in defense industry) or technical
9 files (in medical sector), are used to procure parts by specifying the material requirements, tolerances,
10 geometry and manufacturing processes for a part. This works well for parts made via traditional
11 manufacturing processes as these processes have been standardized over time and are performed to
12 specifications and standards that bound their use and may be referenced as part of the data package.
13 Additive manufacturing processes have not yet been standardized, and as a result the use of typical data
14 package content is not sufficient to procure parts made via these processes.
16  ASME Y14.46 – 2022, Product Definition for Additive Manufacturing

17  ASME Y14.47 – 2019, Model Organization Practices
18  AWS D20.1/D20.1M:2019, Standard for Fabrication of Metal Components using Additive
19 Manufacturing
20  ISO/ASTM52911-1-19, Additive manufacturing — Design — Part 1: Laser-based powder bed
21 fusion of metals
22  ISO/ASTM52911-2-19, Additive manufacturing — Design — Part 2: Laser-based powder bed
23 fusion of polymers
24  MIL-STD-31000B, Technical Data Packages (not AM-specific).
25  SAE EIA649C, Configuration Management Standard (G-33)
27  ASTM WK71395, New Guide for Additive manufacturing -- accelerated quality inspection of
28 build health for laser beam powder bed fusion process (F42.01)
29  ISO/ASTM PWI 52951, Additive manufacturing — Data packages for AM parts
30  MIL-STD-31000C, Technical Data Packages (will address AM)
31 Gap DE17: Contents of a Data Package. The contents of a data package that is sufficiently complete
32 such that it could be provided to a vendor and result in components that are identical in physical and
33 performance characteristics has not been defined.
1 R&D Expectations: Possibly, on how to best identify level of granularity and information identification to
2 meet different application and process needs
3 Recommendation: Develop a standard(s) to describe all required portions of a data package and adopt
4 them into a formal standard(s), regardless of manufacturing process (AM, subtractive, casting). The
5 standard(s) should address issues such as the following (not a comprehensive list):
6
7 • Performance/functional requirements (form, fit assembly)
8 • Qualification requirements
9 • Definition of “as-designed” part, versus “as-printed” part, versus “finished” part
10 • Post-processing requirements (including finishing, removal of parts from AM machine such as
11 separation from build plate)
12 • Applicable AM process as defined in ISO/ASTM 52900
13 • Tailorable and non-tailorable build parameters
14 • Cybersecurity requirements (if necessary)
15 • Long term archival and retrieval process (including acquisition)
17 Organization: ASME Y14.46, ASME Y14.47, ASTM F42/ISO TC 261, AWS, DoD AFRL, NIST, SAE G-33

20 Repair; ☒Data


30 ☐New
31 V3 Update: ASME Y14.46 has been published and it deals with data packages. MIL-ST31000C is in
32 development and will address AM. The ISO/ASTM PWI 52951 is being developed.
33 Data Packages, sometimes referred to as technical data packages (TDPs in defense industry) or technical
34 files (in medical sector), are used to procure parts by specifying the material requirements, tolerances,
1 geometry and manufacturing processes for a part. These parts made via traditional manufacturing
2 processes are often limited to geometry and functional requirements conveyed with 2D drawings. These
3 drawings are also often in a portable document format (pdf). However, to procure parts fabricated with
4 AM processes, additional process information (in addition to the geometric information, is often
5 required. Further, the organic shapes of AM parts are often difficult to document any way other than 3D
6 (thus are to be documented in 3D format per ASME Y14.46). Consequently, a 3D PDF utilizing an
7 embedded Product Representation Compact (PRC) file is often used to document the designs of AM
8 items. This has led to some significant challenges due to gaps in the current available 3D PDF. First, the
9 3D PDF files often need to have a Standard for the Exchange of Product model data file (STEP) file
10 attached to them to support manufacture and inspection. The STEP file as well as the PRC both become
11 authoritative definitions of the part. This leads to large file sizes, but more importantly, it become
12 problematic have multiple definitions of the part. Second, current STEP files have no features and are
13 not parametric. This makes sharing and editing the models difficult.
15  ASME Y14.46 – 2022, Product Definition for Additive Manufacturing

16  STEP-AP242 / ISO 10303-242:2022 Industrial automation systems and integration — Product
17 data representation and exchange — Part 242: Application protocol: Managed model-based 3D
18 engineering (2022-12) but is not AM specific.
19  ISO 32000-1:2008 Document management — Portable document format — Part 1: PDF 1.7
20 which was reaffirmed in 2019 but is not AM-specific.
21  ISO 24517-1:2008, Document management — Engineering document format using PDF — Part
22 1: Use of PDF 1.6 (PDF/E-1) which was reaffirmed in 2022 but is not AM-specific.
23  MIL-STD-31000 B, Technical Data Packages (TDP) (2018-10-31) but is not AM-specific).
25  MIL-STD-31000 C, Technical Data Packages (will address AM)

26  ISO/ASTM PWI 52951. Additive manufacturing -- Data packages for AM parts.
27  ISO/TS 24064 Document management — Portable document format — RichMedia annotations
28 conforming to the ISO 10303-242 (STEP AP 242) specification (2023-03)
29 New Gap DE30: STEP Based 3D PDF. PDF is a common means for viewing 3D parts and annotations, but
30 current capabilities are limited by the PRC file. AM geometry and specifications can be complex and are
31 not well handled by PRC. There is a need for a specification for a pdf file based on a STEP file, which
32 handles these additional complexities, as opposed to the PRC file in ISO spec.
35 Recommendation: Complete work on ISO/DTS 24064.
2 Organization: ASME

4 Material Properties; ☐Qualification & Certification; ☒Nondestructive Evaluation; ☐Maintenance and
5 Repair; ☐Data


13 Current Alternative: Uses current 3D pdf format with a STEP file attached.
14 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
15 ☒New
16
17 New Gap DE31: Feature-based Support for STEP. There is a need for STEP – 242 to be updated to
18 include feature-based information, which is parametric, to better preserve geometry when developed
19 with AM-specific characteristics (generative design, lattice body).
21 R&D Expectations: Consider how different software handle the development of AM-specific design
22 strategies and what requirements are necessary for their neutral representation.
23 Recommendation: ISO revise STEP 242 to address requirements identified in this gap.
25 Organization: ISO / NIST

28 Repair; ☐Data
6 Q&C Category: ☐Materials; ☒Processes/Procedures; ☐Machines/Equipment; ☒Parts/Devices;

8 Current Alternative: Use existing STEP - 242
10 ☒New
11 2.1.5.2 New Dimensioning and Tolerancing Requirements
12 AM offers the opportunity to create geometries never before envisioned. These include new complex
13 features, unit cell structures, and gradient structures. There also exist new requirements for identifying
14 datum directional properties, coordinate systems, part orientation, support material, and build location.
16  ASME Y14.5 - 2018, Dimensioning and Tolerancing, published by the American Society of
17 Mechanical Engineers, is currently under revision to enable better application toward model-
18 based definitions. ASME Y14.5 provides geometric dimensioning and tolerancing (GD&T)
19 language for communicating design intent, ensuring that parts from technical drawings have the
20 desired form, fit, function and interchangeability. Its intent is to establish uniform practices for
21 stating and interpreting GD&T and related requirements for use on engineering drawings and in
22 related documents. The fundamentals of this document can be applied to AM design.
23  ASME Y14.41 - 2019, Digital Product Definition Data Practices, is an AM related but not AM-
24 specific standard published by ASME to establish requirements for model-based definitions
25 upon Computer-Aided Design (CAD) software and those who use CAD software to create
26 product definitions within the 3D model.
27  ASME Y14.46 - 2022, Product Definition for Additive Manufacturing [Draft Standard for Trial
28 Use] which establishes uniform TDP practices for AM. It incorporates, expands, and refines
29 current practices and symbology to enable AM TDPs to be created, interpreted, and consumed.
30 It ensures that these component parts and component assemblies are subject to a single
31 interpretation of engineering specifications and requirements for the purpose of conformance
32 and verification.
33
1  ASME Y14.46 is being revised with further work to be done on verification and validation
2 methods.
3  ASME Y14.48 on Universal Direction and Load Indicator is underway and will provide the ability
4 to unambiguously specify directional requirements for aspects such as: geometric tolerances,
5 elemental tolerance zones, surface texture, application of decals and decorative elements on
6 products, orientation of parts in assemblies, orientation of fibers in composite materials,
7 directions in additive manufacturing, rotational requirements of parts in assemblies, and
8 movement requirements for components in assemblies. Load indicator requirements are
9 planned to include tools for defining such things as: direction, load, fixity, the shape of contact
10 area, load sequence, and other variables needed when applying loads to non-rigid parts.
11
Gap DE18: New Dimensioning and Tolerancing Requirements. ASME Y14.46 has been published and
specifically deals with dimensioning and tolerancing requirements but additional work is needed on
verification and validation.
R&D Needed: ☒Yes; ☐No; ☐Maybe
R&D Expectations: Data to develop new methods and validation practices
Recommendation: Complete work on ASME Y14.46. See also gap DE26 on measurement of AM
features/verifying the designs of features such as lattices, etc.
Priority: ☒High; ☐Medium; ☐Low
Organization: ASME Y14.46, ASME Y14.48, NIST
Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished

Material Properties; ☐Qualification & Certification; ☐Nondestructive Evaluation; ☐Maintenance and
Repair; ☒Data
Sectors: ☒All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☐Electronics;

☐Energy; ☐Medical; ☐Spaceflight; ☐Other (specify) ______________________
Material Type: ☒All/Material Agnostic; ☐Metal; ☐Polymer; ☐Ceramic; ☐Composite
Process Category: ☒All/Process Agnostic; ☐Binder Jetting; ☐Directed Energy Deposition; ☐Material
Extrusion; ☐Material Jetting; ☐Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photopolymerization
Q&C Category: ☐Materials; ☒Processes/Procedures; ☒Machines/Equipment; ☐Parts/Devices;

☐Personnel/Suppliers; ☐Other (specify) ______________________
Current Alternative: None specified
V3 Status of Progress: ☒Green; ☐Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
☐New
V3 Update: As noted in the text.
1
2 2.1.5.3 An Organization Schema Requirement and Design Configuration Control
3 It is critical that designers be able to communicate everything that controls the AM part functionality
4 and maintain configuration management (model version control) to ensure the model definition has not
5 changed for production, quality assurance, and design verification and validation (V&V). AM parts and
6 process definitions can be completely digital and AM parts are tied to how they are made. For example,
7 changes in AM production (such as processing parameters, build orientation, location of part in the build
8 volume, using a different revision of the machine processing software, etc.) could result in materials
9 properties that were not intended for the AM part design.
11  ASME Y14.47 – 2019, Model Organization Practices

13 of Data Pedigree
15 Manufacturing
16  MIL-STD-31000B, Technical Data Packages (not AM-specific).
17  SAE G-33’s SAE EIA649C, Configuration Management Standard
20 build health for laser beam powder bed fusion process
21  ISO/ASTM PWI 52951 -- Additive Manufacturing — Data — Data packages for AM parts
22 Gap DE19: Organization Schema Requirement and Design Configuration Control. AM parts are
23 intrinsically tied to their digital definition. In the event of a design modification, proper methods of
24 configuration and parameter curation are needed for verification. This could include verification of the
25 digital material parameters, process parameters, or software version, if applicable. A comprehensive
26 schema for organizing related information in an AM digital product definition data set will provide
27 traceable, consistent data content and structure to consumers of the data.
30 Recommendation: ASME Y14.47-2019, Model Organization Practices, formerly known as Y14.41.1 may
31 partially address this gap but AM related aspects need to be further developed. ASME Y14.47 is based
32 on Appendix B of MIL-STD-31000A. ASME could also consider multiple schemas (e.g., scan data) that are
33 not currently under consideration within Y14.47. ASME Y14.47 and ISO/TC 10 could incorporate the
1 digital configuration control into their developing standards if they have not already. SAE’s G-33
2 Configuration Management Committee is developing SAE EIA649C, Configuration Management
3 Standard, which is targeted for publication by the third quarter of 2018.
5 Organization: ASME Y14.47, ISO/TC 10, ASTM F42/ISO TC 261 JG 73, AWS, NIST, SAE G-33

8 Repair; ☒Data


18 ☐New
19 V3 Update: The gap D19/DE19 in roadmap version 2 has been satisfied with the publication of Y14.47
20 and the common data dictionary (ASTM F3490) has been published.
21 2.1.5.4 A Neutral Build File Format
22 The current industry standard for file formats is the stereolithography (STL) file. As AM technology has
23 matured, several shortcomings with the STL format have become apparent, such as lack of color,
24 material, density, and orientation. Also, it does not scale well to high resolution and lattices. The
25 ISO/ASTM 52915:20 additive manufacturing file format (AMF) was developed with the assistance of
26 ASTM; however, it has not been fully adopted throughout the industry. It does address some of the STL
27 shortcomings; however, it is still not a complete solution. In a separate development, a consortium led
28 by Microsoft and other partners developed the 3D Manufacturing Format (3MF) standard; however, this
29 standard also does not fully address the requirement. A requirement exists to have a neutral build file as
30 an input to AM machines which would be similar to having a STEP file in subtractive manufacturing;
31 however, it would include supporting structure and laser path as well as other important parameters
32 required by a machine to manufacture a part.
1 It is extremely difficult to document many of the existing parameters and the laser scan paths in a data
2 package. Further, it is impossible to semantically identify this information in anything other than a
3 vendor proprietary format and impossible to associate any of this data with any human readable
4 information. Without a neutral build format, full and open competition can never be fully realized. This
5 lack of competition creates a barrier to government procurements and stifles innovation and
6 development. However, in the current landscape, it will be difficult to realize the goal of a standard
7 since so much of this information is currently in proprietary formats.
11  ISO 14649-17:2020, Industrial automation systems and integration — Physical device control —
12 Data model for computerized numerical controllers — Part 17: Process data for additive
13 manufacturing. Developed independently by ISO TC 184, not yet aligned with ASTM F42/ TC 261.
14  ISO/ASTM 52915:2020, Specification for Additive Manufacturing File Format (AMF) Version 1.2.
15  ISO 10303-242:2022, Industrial automation systems and integration -- Product data
16 representation and exchange -- Part 242: Application protocol: Managed model-based 3D
17 engineering. Commonly referred to as STEP AP242, this ISO standard “specifies the application
18 protocol for Managed model-based 3d engineering.” STEP AP242 can represent exact model
19 geometry, tessellated model geometry, and associated geometric and dimensional tolerances all
20 in one file. Some AM-specific information such as build orientation and location, build surface
21 dimensions, and support geometry are planned for the second edition of AP242.
22  STEP AP238 or STEP-NC is a machine tool control language that extends the ISO 10303 STEP
23 standards with the machining model in ISO 14649-1:2003, adding geometric dimension and
24 tolerance data for inspection, and the STEP product data management model for integration
25 into the wider enterprise. The combined result has been standardized as ISO 10303-238:2020
26 (also known as AP238).
27  3D Manufacturing Format (3MF) is a 3D printing format developed and published by the 3MF
28 Consortium. The 3MF format allows CAD applications to send 3D models to additive
29 manufacturing printers. Although not a voluntary industry standard, this technical specification
30 is a resource being considered in relation to the below gap.
32  ASTM WK48549, New Specification for AMF Support for Solid Modeling: Voxel Information,
33 Constructive Solid Geometry Representations and Solid Texturing. ASTM F42.04 (JG64) is
34 developing this document which “describes existing features for Solid Modeling support within
35 the present Standard Specification of the AMF format and formulates propositions to further
36 AMF interoperability with Voxel Information, Constructive Solid Geometry (CSG) Representation
37 and Solid Texturing.”
38  ISO/ASTM CD TR 52918, Additive manufacturing — Data formats — File format support,
39 ecosystem and evolutions
1
2 As noted above, some standardization has been done in this area through the AMF format developed by
3 ISO/TC 261 and ASTM F42 in close cooperation under their partner standards developing organization
4 (PSDO) cooperation agreement. However, significantly more needs to be done. Industry has not
5 adopted a single standard for AM file format. Having to assess, interpret, or manage differing file
6 formats makes translation of CAD files or their transportability more problematic, making qualification
7 of a design difficult between machines. ISO/TC 184/SC4 has published the ISO 10303 standards and
8 done similar work with CAD files as well as product lifecycle management schemas.
9 Gap DE20: Neutral Build File Format. A standard is needed to provide explicit definitions of process
10 specifications that can be directly interpreted and used by different machines for complete part
11 fabrication. Many other parameters remain unsupported. Ideally, the same file could be used as the
12 input into an AM machine regardless of the vendor of the machine and provide for a uniform output.
13 Industry should work to coalesce around one industry standard for (technology specific) am process
14 specification, which will help to better enable qualification of a design across various platforms.
15 However, the unique technologies of the different vendors could make such an effort challenging.
17 R&D Expectations: Developing information models that expand current AP238 and 242 capabilities and
18 extend them to AM. Testing these information models at NIST to drive a build.
19 Recommendation: Develop standards content for the computer-interpretable representation and

20 exchange of additive manufacturing product and process information that can represent all of the
21 applicable slice files, build path, and feedstock, as well as the other applicable parameters into a single
22 neutral file. This file would be used to exchange data between AM vendors and have the capability to be
23 used instead of proprietary file formats and material parameter sets. See also gap DE8 on machine input
24 and capability report.
26 Organization: ISO/TC 184/SC4, ISO/TC 261/ASTM F42, consortium of industry, IEEE-ISTO PWG

29 Repair; ☒Data

3 Current Alternative: Proprietary formats used by individual vendors. Neutral representations are limited
4 to the original geometry files. Proprietary meta data and files included in ISO/ASTM 52915:20 AMF
5 format files.
7 ☐New
8 V3 Update: ISO/ASTM52915:20 (AMF) includes the capability of incorporating the additional technical
9 information described here as meta data attributes. Updates to ISO/ASTM 52915:20 could expand the
10 current support for inclusion of meta data and other essential information within the file to address this
11 gap.
12 2.1.5.5 New Terminology in Design Documentation
13 In AM, numerous new terms (e.g., build volume, staircase effect) are used which are often referred to in
14 design documentation. These terms need to be clearly and legally defined if they are to be used in a
15 data package.
17  ASME Y14.46-2022, Product Definition for Additive Manufacturing establishes uniform TDP
18 practices for AM. It incorporates, expands, and refines current practices and symbology to
19 enable AM TDPs to be created, interpreted, and consumed. It ensures that these component
20 parts and component assemblies are subject to a single interpretation of engineering
21 specifications and requirements for the purpose of conformance and verification.
24  ISO 17295:2023, Additive manufacturing — General principles — Part positioning, coordinates
25 and orientation
26  ISO/ASTM 52900-21, Additive manufacturing - General principles – Fundamentals and
27 Vocabulary.
28  ISO/ASTM 52921-13 (2019), Standard terminology for additive manufacturing - Coordinate
29 systems and test methodologies.
30  ISO/ASTM 52950-21, Additive manufacturing — General principles — Overview of data
31 processing
32
33 Gap DE21: New Terminology in Design Documentation. While some AM terminology standards already
34 exist, they do not include certain terms referred to in design documentation. Terminology in a data
35 package needs to be clear.
3 Recommendation: ASME Y14.46 has identified terms for design documentation that are not defined in
4 existing AM terminology standards. Once this work is completed, it should be referred to ISO/TC
5 261 and ASTM F42 for inclusion in existing standards such as ISO/ASTM 52900.
7 Organization: ASME, ISO/ASTM

10 Repair; ☐Data


17 ☐Personnel/Suppliers; ☒Other (specify) Terminology
18 Current Alternative: None specified
20 ☐New
21 V3 Update: The gap, as originally framed, has been closed. Terminology standards will continue to be
22 regularly revised. ASME Y14.46-2022 has been published. ASME Y14.46 references ISO/ASTM AM
23 terminology standards (ISO/ASTM 52900 and ISO/ASTM 52921) as much as possible but also had to
24 create new AM terminology specific to AM Product Definition. The ASME Y14.46 AM-related terms were
25 sent to ASTM.
26 2.1.5.6 In-Process Monitoring
27 Additive manufacturing offers the capability to have significant in-process monitoring. The availability of
28 in-process monitoring has grown significantly, and development is still expected in the next several
29 years. This will dictate what data should be captured and when and how this data may be used to
30 provide assurances that a part was made to a required specification. The ability to qualify a material,
31 process, or part(s) using in-process monitoring is anticipated to eventually support design allowables
1 and quality assurance, either directly or through validation of computational models. Currently, metal
2 additive manufacturing involves multiple physical phenomena and parameters that potentially affect the
3 quality of the final part. To capture the dynamics and complexity of heat and phase transformations that
4 exist in the AM process, computational models and simulations ranging from low- to high-fidelity have
5 been developed. Since it is difficult to monitor all physical phenomena encountered in an AM process,
6 computational models rely on assumptions that may neglect or simplify some physical phenomena.
7 Modeling uncertainty plays a significant role in the predictive accuracy of such AM models, and ‘ground
8 truth’ validation data, potentially from in-process monitoring, is necessary to evaluate this uncertainty.
9 There is a lack of standards for validated physics- and properties-based predictive models for AM that
10 incorporate geometric accuracy, material properties, defects, surface characteristics, residual stress,
11 microstructure properties, and other characteristics (NIST, 2013).
12 Though not specifically targeting model validation, ASTM CoE’s “Strategic Guide: Additive Manufacturing
13 In-Situ Technology Readiness” illustrates existing technological and standardization gaps for in-process
14 monitoring.
15 A related gap (PC16) is mentioned in 2.2.2.11 Process Monitoring. The in-process monitoring data
16 covered by PC16 includes real-time data obtained on the feedstock (supply ratios and other metrics),
17 process conditions (atmosphere, humidity), process parameters (beam diagnostics such as location,
18 laser power, scan width, scan rate), and the part during build (dimensions, surface finish,
19 microstructure, density, hot spots, defect state). The R&D Expectations and Recommendations for Gap
20 PC16 are largely the same for applications of In-process Monitoring for design and/or model validation
21 (see also to gap DE9: AM Simulation Benchmark). Gap PC16 replaces the need for the Roadmap version
22 2.0 design gap D22 on in process monitoring.
23 2.1.5.7 Documentation of New Functional Features and Surface Features
24 Additive manufacturing offers the opportunity for design of new functional features and surface finishes
25 as described in section 2.1.4. Design for Specific Applications. Features and surfaces may be optimized to
26 meet different functional requirements including, increased friction, thermal cooling, light weighting, or
27 increased biologic activity. For instance, the outer portion of a part may contain regular grid lattice
28 structures that can be used to reduce the weight of a solid part or improve bone attachment in
29 orthopedic implants. Typically, these features are described by highlighting the area and identifying that
30 they will be porous, grid, or lattice with leader lines. Basic information on the pattern is then provided in
31 a table, but it is often insufficient to duplicate the part consistently. They can sometimes be
32 documented by specifying the central axis length of each strut and its thickness. However, this quickly
33 becomes ambiguous if the lattice is random, algorithmic, or does not cleanly match the part profile.
34 Additionally, similar complex patterns could be incorporated into the part’s surface finish. Additively
35 manufactured parts can also have unique surface finishes that are characteristic of the manufacturing
36 processes, rather than the design. Either intended or unintended, the resulting surfaces are difficult to
37 characterize and document by currently available methods and metrics. New standards are needed to
38 characterize and specify AM surface finishes.
1 There are currently no established standardized means to document the geometric/tolerancing
2 requirements of these complex features and surface finishes.
4  ASME Y14.46-2022, Product Definition for Additive Manufacturing [Draft Standard for Trial Use],
5 which establishes uniform TDP practices for AM.
6  ASME B46.1 – 2019, Surface Texture (Surface Roughness, Waviness, and Lay)
7
9  ASME B46 Project Team 53 is working on this effort and will either revised B46.1 or develop a
10 separate document.
11  ASTM WK65929, New Specification for Additive Manufacturing-Finished Part Properties and
12 Post Processing - Additively Manufactured Spaceflight Hardware by Laser Beam Powder Bed
13 Fusion in Metals (F42.05)
14  ASTM WK65937, New Specification for Additive Manufacturing -- Space Application -- Flight
15 Hardware made by Laser Beam Powder Bed Fusion Process (F42.05)
16  ASTM WK66682, Guide for Evaluating Post-processing and Characterization Techniques for AM
17 Part Surfaces (F42.01)
18  ASTM WK83110, Practice for Additive Manufacturing – Powder bed fusion – Measurement for
19 load-bearing area for mechanical testing with as-printed surfaces (F42.01)
20 Gap DE23: Documentation of New Functional and Complex Surface Features. There is a need for a
21 specification on design documentation for intentionally introducing new bulk or surface geometries
22 which can be created through AM.
25 Recommendation: ASME Y14.46 should consider an annex describing a method to document functional
26 and complex geometric features.
28 Organization: ASME

31 Repair; ☐Data


6 Current Alternative: For documentation for design, unknown. For inspection, micro CT (measure vs
7 model evaluation) or optical profilometry may be used.
9 ☐New
10 V3 Update: As noted in the recommendation. ASME Y14.46-2022 been published but does not address
11 the recommendations at this time.
12
13 Gap DE28: Specification of Surface Finish. There is a need for a specification on desired surface finishes
14 of AM parts that can later be measured and validated against. Current surface finish metrics, such as Ra,
15 do not adequately specify surface finish requirements. A surface metric which can be correlated with
16 fatigue is needed.
18 R&D Expectations: Continued characterization of AM surfaces in order to confidently relate to the

19 performance of the part.
20 Recommendation: ASME revise ASME B46.1 to address specification requirements of AM surface

21 finishes. ASTM to complete its work on ASTM WK66682.
23 Organization: ASME, ASTM

26 Repair; ☐Data

3 Current Alternative: All machining of critical surfaces, and design point solutions as opposed to process-
4 oriented solutions.
6 ☐New
7 V3 Update: ASME B46.1-2019 was published which added a section to Appendix B of the standard
8 regarding surface texture of AM parts. This is currently a generalized section with several references to
9 ISO, ASTM, and ANSI standards or guides. In the future, the section will be expanded upon, possibly
10 moving to a section within the standard, as opposed to being an appendix. ASTM AM CoE Strategic
11 Roadmap for Research & Development notes that AM CoE Projects 1802 (WK66682) and 1804/1907
12 (WK65937, WK65929) address AMSC Gap DE28.
13 2.1.5.8 An Acquisition Specification
14 A specification will be required to procure AM parts from third parties.
16  ISO/ASTM 52901, Additive manufacturing – General Principles – Requirements for Purchased

17 AM Parts
18  SAE AMS7004, Titanium Alloy Preforms from Plasma Arc Directed Energy Deposition Additive
19 Manufacturing on Substrate, Ti-6Al-4V, Stress Relieved (2019-01-31)
20  SAE AMS7008, Nickel Alloy, Corrosion and Heat-Resistant, Powder for Additive Manufacturing,
21 47.5Ni – 22Cr – 1.5Co – 9.0Mo – 0.60W – 18.5Fe (2019-03-26)
22  SAE AMS7012, Precipitation Hardenable Steel Alloy, Corrosion and Heat-Resistant Powder for
23 Additive Manufacturing 16.0Cr – 4.0Ni – 4.0Cu – 0.30Nb (2019-11-14)
25 60Ni – 22Cr – 2.0Mo – 14W – 0.35Al - 0.03La (2019-01-03)
26  SAE ARP7043, Recommendations for an Additive Manufacturer Designing/Repairing Aircraft
27 Components (2022-08-05)
29  SAE AS7041, Distributor for AM build distributors Requirements (AMS AM)
30
1 2.1.6 Design Verification and Validation
2 The verification and subsequent validation (V&V) of a design are important steps to ensure it fulfills its
3 goals and application. V&V requirements are also common in most quality management standards such
4 as ISO/IEC 17025 and ISO 9000. For the purpose of this document, verification is defined as the
5 confirmation, through the provision of objective evidence, that specified requirements have been
6 fulfilled. Validation is defined as confirmation, through the provision of objective evidence, that the
7 requirements for a specific intended use or application have been fulfilled.6 Guidelines to inform design
8 decisions that will facilitate their measurement and subsequent verification and validation would be
9 advantageous.
10 A design is the basis of verification, which can be accomplished using a variety of methods depending on
11 the application needs. To explore how AM specifically impacts V&V, it is assumed that some design
12 elements will frequently arise during verification. These elements—listed below—formed the basis of
13 the current gap analysis. Verifying an AM design likely requires specific guidelines for:
14  developing of specifications or methods of comparing to specifications

15  structural, thermal, physical, and chemical performance
16  requirements for post-processing
17 o Standard practices and specifications for newer post-processing techniques for surface
18 finishing will be required to standardize these practices. This includes the measurement
19 of surface finishes during validation, if surface texture is a critical feature.
20  dimensional analysis
21 o Geometric dimensioning and tolerancing specifications and practices must be fully
22 applicable to AM. Evaluating these components will likely occur in most design review
23 processes.
24  methods of model version/configuration control in the digital definition of AM designs
25 o Geometrical dimensioning and tolerancing will likely be included in these models, and
26 the feature definitions must be fully compatible with AM.
27
28 Validation standards are application specific. Space, health/medical, industrial, food, petroleum,
29 construction, mechanical (welding, pressure vessels, etc.). AM validation will likely require testing for
30 defects. See Chapter 2.4 Nondestructive Evaluation (NDE) for related standards activities.
31 Published statistical guides for guiding sample sizes for experiments are under the jurisdiction of ASTM
32 Committee E11, though specific sampling recommendations for AM materials testing likely fall under
33 jurisdiction of ASTM F42. Currently open questions include:
34 1) What is the appropriate number of builds to validate a design for AM with respect to costs?
35 2) How much of the build volume needs to be captured?
36
6
Definitions of verification and validation are taken from ISO 9000:2015.
1 Test Methods
2 Both verification and validation depend on the final application. Therefore, AM designs should be
3 verifiable using existing guidelines and methods for each application. One case, design for
4 manufacturing and assembly, may require additional guidelines for AM. Listing each approach that can
5 be used for validation of a design is a significant undertaking and outside the scope of this section, and
6 addressing individual tests used for validation is left to the remaining sections of this roadmap.
7 An approach that could form the basis of some validation approaches is Gage Repeatability and
8 Reproducibility (R&R) studies. Currently, the repeatability of AM is not well characterized, and the R&R
9 process may play a role in maturing the manufacturing technologies. Standards BS ISO 21748:2017,
10 Guidance for the use of repeatability, reproducibility and trueness estimates in measurement
11 uncertainty estimation (British Standard) and ISO 5725, Accuracy of Measurement Methods and Results
12 Package (managed by ISO/TC 69/SC 6) provide guidelines for this approach; further information can be
13 found in ISO/TR 12888:2011, Selected illustrations of gauge repeatability and reproducibility studies
14 (ISO/TC 69/SC 7).
16  ASME PTC 19.1-2018, Test Uncertainty

17  BS ISO 21748:2017, Guidance for the use of repeatability, reproducibility and trueness estimates
18 in measurement uncertainty estimation (British Standard)
19  FDA-2016-D-12107, Technical Considerations for Additive Manufactured Medical Devices (2017-
20 12).
21  ISO 5725, Accuracy of Measurement Methods and Results Package
22 o ISO 5725-1:1994, Accuracy (trueness and precision) of measurement methods and results —
23 Part 1: General principles and definitions (reconfirmed in 2018)
25 Part 2: Basic method for the determination of repeatability and reproducibility of a standard
26 measurement method
28 Part 3: Intermediate measures of the precision of a standard measurement method
29 (reconfirmed in 2013)
31 Part 4: Basic methods for the determination of the trueness of a standard measurement
32 method
7
See also FDA background information on Process of 3D Printing Medical Devices. Last accessed on April 5, 2023.
https://www.fda.gov/medical-devices/3d-printing-medical-devices/process-3d-printing-medical-devices
2 Part 5: Alternative methods for the determination of the precision of a standard
3 measurement method (reconfirmed in 2018)
4 o ISO 5725-6:1994, Accuracy (trueness and precision) of measurement methods and
5 results — Part 6: Use in practice of accuracy values
7 recommendations
8  ISO/TR 12888:2011, Selected illustrations of gauge repeatability and reproducibility studies
9
11 In development standards for the topics above are limited, especially for AM-specific applications.
12 Below are works-in-progress for material properties and design guides.
13  ASME Y14.46 – 2022, Product Definition for Additive Manufacturing, ASME is also in the process
14 of producing AM design guides, which may provide guidelines for design verification.
15  ASTM WK71395 New Guide for Additive manufacturing -- accelerated quality inspection of build
16 health for laser beam powder bed fusion process (F42.01)
17  ASTM WK72659, New Guide for Guideline for Material Process Validation for Additive
18 Manufacturing of Medical Devices (F42.07)
19  ISO/ASTM CD 52918, Additive manufacturing — Design — Requirements, guidelines and
20 recommendations (see also WK83512)
21
22 Gap DE26: Design for Measurement of AM Features/Verifying the Designs of Features such as Lattices,
23 etc. As noted in gap DE18, working groups are currently developing methods to standardize the
24 geometric dimensioning and tolerancing (GD&T) of AM parts. As these mature, existing V&V methods of
25 checking part conformance to GD&T specifications must be investigated for their compatibility with AM.
26 As part of the design process for AM, the availability of methods to measure and verify AM-unique
27 features must be considered, especially to meet critical performance requirements. This may result in
28 adapting existing NDE methods or creating new methods. This will likely be relevant when measuring
29 AM features such as helixes or other complex shapes, or internal features that are not compatible with
30 common methods such as Go/No-Go gauges or coordinate measuring machines (CMM). Especially in the
31 case of internal features, assessing the ability of ultrasonic or radiographic methods to validate high
32 tolerances will be required.
34 R&D Expectations: Investigation of high resolution radiographic and ultrasonic methods and the
35 maximum achievable resolution and accuracy for GD&T of complex AM designs.
36 Recommendation: As GD&T standards continue to develop, perform parallel investigations of validation

37 methods to ensure V&V is possible. See also gap NDE4, Dimensional Metrology of Internal Features.
2 Organization: ISO/TC 261/ASTM F42, ASTM E07.01, ASTM E07.02, ASME B89, ASME Y14.46, ISO/TC 10

5 Repair; ☐Data


13 Current Alternative: Policy and regulations would address this. The medical sector is using FDA guidance
14 and ASTM F1854 for design of lattices although not optimized for CT or AM related. Military leverages
15 contractual agreements.
17 ☐New
18 V3 Update: A standard on methods to verify that complex AM parts meet design requirements is
19 needed. ASME Y14.46 will address how to document AM-unique design features, but not how to
20 inspect/verify the design. Y14.46 included a non-mandatory appendix with guidance on quality
21 assurance (QA) parameters and references that may be used to develop design validation methods.
22 ASME B89 (dimensional metrology) is working jointly with Y14.46. ISO/ASTM 52910-18 provides
23 guidance for AM designers to “work with their quality groups to ascertain if appropriate inspection and
24 qualification processes are available or need to be developed for the types of parts that they are
25 designing.”
26 2.1.7 Design for Anti-counterfeiting

27 Anti-counterfeiting is a concern in manufacturing and relevant in AM applications, including printed
28 electronics, medical, aviation, and automotive, along with performance athletics, toys, and other
29 branded goods. Products that appear genuine may contain flaws. Designing anti-counterfeiting
30 measures into products (vs. forensic analysis after a failure) offers better chances of preventing
31 sabotage and injury. Best practices include:
1 Design for anti-counterfeiting features. Make it possible to include an identifying feature such as a
2 chemical taggant mix including graded materials options; porosity; a void pattern; or an electronic tag.
3 Covert features are preferred. Surface features can be scanned and reproduced by a counterfeiter, and
4 may not survive post-processing. In existing markets with high levels of counterfeiting (e.g., luxury
5 goods, pharmaceuticals), overt features reassure consumers but have been quickly replicated by
6 counterfeiters.
7 Simple validation techniques protect better. When testing is simple (e.g., fast, easy, field-friendly, non-
8 destructive, inexpensive, off-the-shelf, etc.), it is more widely deployed.
9 Coordinate with cybersecurity. Materials-based and pattern-based features can be part of the build,
10 e.g., as a covert sub-surface mark. Instructions for such features can be encrypted and subject to
11 appropriate security controls, including blockchain, in the build file.
12 Align with Data Package. Incorporating anti-counterfeiting at the design stage enables fast data package
13 compliance screening in the final product. Products that lack anti-counterfeiting measures may warrant
14 additional scrutiny. See Process Control section 2.2.2.13 Anti-counterfeiting and NDE section 2.4.7 NDE
15 of Counterfeit AM Parts.
17  ISO/ASTMTR52906-EB, Additive Manufacturing—Nondestructive Testing—Intentionally Seeding

18 Flaws in Metallic Parts (see also ISO/ASTM TR 52906:2022)
20  ISO 22380:2018 Security and resilience — Authenticity, integrity and trust for products and
21 documents — General principles for product fraud risk and countermeasures
22  SAE AS5553D-2022, Counterfeit Electrical, Electronic, and Electromechanical (EEE) Parts;
23 Avoidance, Detection, Mitigation, and Disposition (2022-04-14)
24  SAE AS6174A-2014 (SAE AS6174A-2014), Counterfeit Materiel; Assuring Acquisition of Authentic
25 and Conforming Materiel (2014-07-29)
26
27 There were no in-development standards identified.
28 New Gap DE29: Best Practices for Design for Anti-counterfeiting. Discontinuities, watermarks and even
29 voids may be intentionally introduced in order to address the concern of counterfeiting, e.g., by
30 inserting other materials or varying internal texture as a hidden signature. Alignment of anti-
31 counterfeiting feature detection with broader quality testing captures the fact that a counterfeit AM
32 part is a quality failure. Standards exist for detection, mitigation, etc., however design standards are
33 needed for intentionally introducing discontinuities for AM parts.
35 R&D Expectations: TBD
1 Recommendation: Develop best practices which address how to design in covert features, such as
2 internal patterns, physical or chemical, and electronic tags, avoid those vulnerabilities which provide
3 techniques for IP management. Develop standards which provide guidance on how to:
4 (1) Design anti-counterfeiting features so that their monitoring can be folded into existing test protocols.
5 Counterfeits and quality failures both encompass potential deviations in materials, tolerances, and print
6 parameters.
7 (2) Design with an eye toward coordinated testing, to reduce the economic burden of separate anti-
8 counterfeiting measures and to enhance the likelihood of adoption of IP protection.
9 See also sections 2.2.2.13 Anti-counterfeiting (process control), 2.4 NDE gaps NDE2 and NDE7) and
10 2.6.7.3 Technical and IP Authentication and Protection (gap DA19)
12 Organization(s): ISO/ASTM

14 Material Properties; ☒Qualification & Certification; ☒Nondestructive Evaluation; ☒Maintenance and
15 Repair; ☒Data


23 Current Alternative: Proprietary efforts.
25 ☒New
26 Other Design Standards Activity Since Roadmap v2 – Relevance to Sections/Gaps Not Yet
27 Determined
28 New Published Standards
29 No additional published standards were identified.
1 New In Development Standards
2  WK74932 Standard Specification for Additive Manufacturing of metals -- Qualification principles

3 -- Qualification of designers (F42.05)
1
2
3
4
5
6
7
8
9
10
11
13
1 2.2 Process and Materials
2 It is rare that a finished product can be entirely manufactured within a single process. Normally, a series
3 of operations and sub-processes are required to achieve the intended combination of geometrical shape
4 and desired properties. However, in the context of AM there is a distinction between which operations
5 are indispensable parts of the additive process and which are more product- and application-dependent
6 pre-processing and post-processing operations. This section discusses AM materials and processes in
7 accordance with the four subgroupings around which the AMSC has organized itself, starting with
8 Precursor Materials, moving on to Process Control, then Post-processing, and, finally, Finished Material
9 Properties.
10 2.2.1 Precursor Materials
11 2.2.1.1 Introduction8
12 Additive manufacturing is not a singular manufacturing technique. It covers a variety of technologies to

13 build parts directly from three-dimensional design data and using different precursor materials. These
14 include metals, polymers, ceramics, and composites, which could vary greatly in their type, form,
15 properties, and characteristics.
16 The technologies used to build a part will determine the various physical forms of the precursor
17 materials, including but not limited to: powders, wires, pellets, filaments, conductive inks, and liquids.
18 As new technologies enter the market, this list may grow. For the industry to be able to confidently
19 select the precursor material and produce consistent parts with predictable quality for a critical
20 application, it is necessary to determine the properties of the precursor materials. The industry will
21 therefore benefit from a standardized measurement of the absolute properties of the precursor
22 materials and the impact of their change through the AM process. This will also open up opportunities
23 to develop new and novel materials for the AM processes and platforms that currently rely, for the most
24 part, on off-the shelf material systems designed for specific manufacturing techniques.
25 While a large body of work pertaining to standard test methods is being carried out globally, more work
26 is needed to address the variation in precursor materials. What is applicable for metals may have no
27 relevance to polymers and liquids. The reciprocal is also true. The impact of the energy input to material
28 conversion will further complicate standardization. For example, the energy directed at the materials to
29 build a part may come from a variety of sources (e.g., electric arc, plasma transfer arc, laser, electron
30 beam gun, etc.).
31 Today, precursor material requirements differ, even within one materials family, from one AM
32 equipment manufacturer or application to another. For example, a metal part being built using a laser as
8
The Precursor Materials working group defined the scope of this section as encompassing everything related to
the precursor material up until it is used to make a component.
1 the energy source may specify differing powder particle sizes and particle size distributions. The
2 differences arise from earlier development work done by the equipment manufacturers or the facilities
3 manufacturing the AM parts. An added layer of complexity comes from the desire to achieve differing
4 levels of surface resolution on the as-built part. The finer the resolution, the less surface preparation or
5 machining is needed. The list of permutations is extensive.
6 The numerous alternatives are exacerbated by the individual AM equipment manufacturers, high
7 liability versus low-liability market requirements, and the fitness-for-use of every unique part.
8 The need is clear. Industry-wide standards and specifications for precursor materials must be
9 established and published.
10 Metals
11 Metal feedstock is generally in the form of powders, wires, and sheets. Below are some examples of
12 how the metal feedstock is used. This is not an exhaustive list.
13 For example, powder bed fusion (PBF) processes using laser (L) and electron beam (EB) rely on metal
14 powder with a chemistry, particle size, and morphology tailored for the specific AM metal process.
15 Spherical powder is sieved to an acceptable particle size distribution (PSD) to suit PBF-L or PBF-EB
16 processes. The number of common engineering alloy powders optimized for PBF processes and specific
17 applications is currently limited but will increase with greater adoption of the technology. Commercial
18 metal powders used by the directed energy deposition (DED) laser process offer a wider range of alloy
19 selection. These alloys include hard facing alloys and materials in wider use, such as those used for laser
20 cladding. Issues associated with AM metal powders include consistency of chemistry, PSD, shape
21 morphology, micro-porosity, or contaminants picked up during powder production.
22 DED processes using electron beam and electric arcs currently rely on solid wire feedstock optimized for
23 use in conventional weld processing. Production of weld wire is covered under existing industrial
24 standards. Standards exist for commercial material shapes such as build plates that become integral to
25 the final AM part. In addition, part complexity in manufacturing 3-dimensional parts, repairing,
26 refurbishing, or re-engineering used parts by powder-based DED processes may necessitate varieties of
27 precursor materials.
28 Polymers
29 The precursor materials for additively manufactured polymer components are based on semicrystalline
30 thermoplastics, elastomers, epoxies, photopolymers, and sometimes polymer composites and filled
31 polymers. The most frequently used AM processes are: (i) Powder Bed Fusion (PBF), sometimes referred
32 to as Laser Sintering, Selective Laser Sintering (SLS) or Melting (SLM); (ii) Material Extrusion, e.g., Fused
33 Deposition Modeling (FDM); (iii) Vat Photopolymerization, e.g., Stereolithography (SLA) or Digital Light
34 Processing (DLP); and (iv) Material Jetting, e.g., Plastics Jet Printing (PJP). As described in the preceding
35 sentence, the precursor material is in the form of powder for process (i), monofilaments or pellets for
36 (ii), and liquid for (iii) and (iv) above.
1 Hybridization of AM with other processes, such as Laser Direct Writing (LDW), is also used for structural
2 electronics where conductive and insulating materials are deposited.
3 The current repertoire of polymer materials available for PBF includes: acrylonitrile butadiene styrene
4 (ABS), polycarbonate (PC) polymer blends based on ABS and PC, polyamide (PA), polylactic acid (PLA),
5 polyvinyl alcohol (PVA), polyether ether ketone (PEEK), thermoplastic flame retardant (FR) compounds,
6 epoxies, etc. AM also allows combinations of plastics with carbon fiber and polymer matrix composites
7 (PMC).
8 The PBF process relies on the flow properties of polymeric powders for sensitive differentiation:
9 cohesion of powder affecting packing (static) and flow efficiency (dynamic), flowability of powder during
10 powder layer application, and packing efficiency of powders inside the feeders and build chambers.
11 Requirements on powder qualities and interaction of process parameters with intrinsic (melting point,
12 melt flow) and non-intrinsic (shape, size, flowability) properties of powders need to be understood.
13 The FDM process is a polymer extrusion process. The strength of the fused layer formed by the
14 deposited molten polymer beads depends on many factors such as temperature gradient (process
15 parameter) and polymer structure (molecular weight, branching, heat of fusion, glass transition
16 temperature), molten bead surface roughness, and spacing.
17 Ceramics
18 Currently, ceramic feedstocks include: powder, for powder bed process, such as ink jet printing and
19 indirect SLS; filament, blended ceramic and polymer for FDM process; paste/slurry, UV curable
20 paste/slurry, for stereolithography process; and paste, for extrusion-based 3D printing and direct ink
21 writing process. Ceramic and polymer blended sheets are still used in certain laminating ceramic AM.
22 However, the application is limited and with no significant growth in the past decades.
23 The requirements of rheological properties, particle morphology, and particle size/size distribution
24 should be same for ceramic as for metal materials. The purpose is to form a smooth and high packing
25 density powder bed, and further achieve dense and defect-free sintered parts. The property controls
26 should be focused on flowability and packing density. Higher flowability9 and packing density usually
27 generate high ceramic green density and less defects. Flowability is normally determined by ceramic
28 particle morphology, particle size, and particle size distribution, while the green density is determined
29 by packing density that is related to particle size and particle size distribution. Usually, bi-model or tri-
30 model particle size distribution is required to achieve high powder bed packing density. Powder
31 rheometry should be incorporated in characterization of ceramic powders. The binder system is
9
It should be noted that powder flowability is not an inherent property of the powder. It not only depends on
particle sizes, shapes, and moisture content in the powder but also on the equipment and methods used. For
example, the powder that cannot flow through a Hall funnel can still flow in other rheometers.
1 important for forming a strong green. Two aspects should be characterized for a binder system. The first
2 is the binding strength and the second is the burnout behavior during post-processing.
3 Many types of thermal plastic can be blended with ceramic powders to form filaments that are suitable
4 for FDM. The thermal properties and rheological properties are important. High solids loading
5 ceramic/polymer filament with ideal rheological properties at the processing temperature is critical for a
6 ceramic FDM process. The other aspect for polymers used for ceramic filament is the burnout behavior
7 during the post-processing.
8 Ceramic stereolithography additive manufacturing uses UV curable resins blended with ceramic
9 powders to form a UV curable slurry that can be cured to the depth at least 30 µm. If the curing depth is
10 less than 30 µm, it will be difficult for current ceramic stereolithography printers. The critical properties
11 of UV curable ceramic slurries also include ceramic solids loading; less than 40 vol.% will generate
12 difficulties in achieving high sintering density. High polymer (binder) loading in the ceramic greens
13 makes the binder burnout more challenging for thick wall components (>10 mm thick). Defects can form
14 during the binder burnout if the binder decomposition is too fast and builds up high pressure in local
15 areas. The high pressure will break the components and form defects. The parts may explode
16 completely if the binder burnout cycle is too aggressive. Characterizing feedstock materials should focus
17 on curing ability, ceramic solids loading, and post-processing behaviors.
18 Most of extrusion-based ceramic AM uses aqueous paste/slurry to form 3D ceramic green. It involves
19 only a limited binder. The most important characteristics of the feedstock material are the rheology
20 properties and ceramic solids loading. Direct ink writing involves organic-based slurry. Rheology is most
21 important since most of direct ink-write do not involve post-processing.
22 Composites
23 Composites in Additive Manufacturing broadly speaking encompasses not just fiber reinforced polymer
24 materials, but should also be seen to include aggregate reinforced materials. The precursor standards
25 for the primary or matrix material are substantially the same as that for that material and process
26 without the addition of functional secondary materials. Specifications for the functional secondary
27 materials must include those generally applicable for the composite material (e.g., fiber sizing), with
28 additional controls for the AM process to be implemented.
29
30 2.2.1.2 Storage, Handling, and Transportation (metals, polymers)
31
32 Metals10
33 In any manufacturing process, proper storage and handling of raw materials is paramount to safety and
34 the quality of the resultant product.
10
This section does not discuss metal wire.
1 In storage, it is necessary to take steps to protect the product and limit the size of a fire or explosion. All
2 containers should be kept sealed and stored unopened in an area separate from handling areas. When a
3 container of powder is opened for loading or inspection, it should be closed and resealed as quickly as
4 possible. To prevent contamination and moisture pick up, powder containers should be opened in areas
5 with controlled atmosphere (temperature, humidity) and clean environment. This not only ensures
6 greater safety against fire from external sources, but also prevents possible entrance of minor
7 contaminants or moisture from the air. All containers in work areas should be closed and sealed. Only
8 those in actual use should be open at any time.
10  ISO/ASTM 52907:2019, Additive manufacturing – Feedstock materials – Methods to characterize

11 metallic powders
12  ISO/ASTM 52931:2023, Additive manufacturing of metals — Environment, health and safety —
13 General principles for use of metallic materials
14 Dust generated when handling powders is inherently dangerous therefore care must be taken to store
15 and use powders in accordance with the guidelines provided by OSHA and the suppliers’ Material Safety
16 Data Sheets (MSDS or just SDS.) Applicable standards for the preparation of those MSDS may be found
17 in ANSI Z400.1/Z129.1-2010, Hazardous Workplace Chemicals - Hazard Evaluation and Safety Data Sheet
18 and Precautionary Labeling Preparation.
19 Below are some of the standardized tests that can be conducted to characterize combustibility of
20 flammable solids/powders. This is by no means a complete list.
21  ASTM D1929-20, Standard Test Method for Determining Ignition Temperature of Plastics
22  ASTM E1226-19, Standard Test Method for Explosibility of Dust Clouds
23  ASTM E2019-03(2019), Standard Test Method for Minimum Ignition Energy of a Dust Cloud in
24 Air
25  DOT/UN Division 4.1 - Burning Rate Test
26  DOT/UN Division 4.2 – Self-Heating Substances Test
27
28 The National Fire Protection Association (NFPA) also maintains a number of relevant standards and
29 other documents supporting the safe storage and handling of metal powders as follows:
30  NFPA 68-2018, NFPA 68 Standard on Explosion Protection by Deflagration Venting, 2018 Edition
31  NFPA 69-2019, Standard on Explosion Prevention Systems, 2019 Edition
32  NFPA 70-2020, National Electric Code (NEC) Softbound, 2020 Edition
33  NFPA 77-2019, Recommended Practice on Static Electricity, 2019 Edition
34  NFPA 91-2020, Standard for Exhaust Systems for Air Conveying of Vapors, Gases, Mists, and
35 Particulate Solids, 2020 Edition
36  NFPA 484-2022, Standard for Combustible Metals
1  NFPA 499-2021, Recommended Practice for the Classification of Combustible Dusts and of
2 Hazardous (Classified) Locations for Electrical Installations in Chemical Process Areas
3  NFPA 652-2019, Standard on the Fundamentals of Combustible Dust, 2019 Edition
4  NFPA 654-2020, Standard for the Prevention of Fire and Dust Explosions from the
5 Manufacturing, Processing, and Handling of Combustible Particulate Solids, 2020 Edition
6  NFPA Fire Protection Handbook, 20th Edition
7
8 The Department of Homeland Security (DHS) requirements of The Chemical Facility Anti-Terrorism
9 Standards (CFATS) requires all facilities to submit a Top Screen if they possess/store more than 100
10 pounds of aluminum or magnesium metal powder.
11 Labeling is governed by OSHA 29 CFR 1910.1200 for hazard communication. Shipping is governed by the
12 Code of Federal Regulations (CFR) Title 49 Transportation Part 173.124 Class 4, Divisions 4.1 Flammable
13 Solid, 4.2 Spontaneously Combustible Material, and 4.3 Dangerous when wet material (49 CFR
14 §173.124) for combustible metal powders. Note that other chemical hazardous material classifications
15 may be relevant to some powders as well, such as chromium. See also CFR 49 Transportation in and out
16 of the USA.
18  ASTM WK80171, New Guide for Additive Manufacturing of Metals – Feedstock Materials –
19 Measurement and Classification of Feedstock Contamination
20 New Gap PM11: Segregation of Powder. A standard practice is not yet established to homogenize
21 powder that may segregate on size or other attributes throughout the lifecycle of handling or usage
22 during an additive manufacturing workflow. This includes activities such as transportation, handling,
23 storage, and consumption within batch and closed-loop AM equipment.
25 R&D Expectations: Evaluation of the effectiveness of different blend methods
26 Recommendation: Recommended practices should be drafted to address potential scenarios where

27 segregation may occur (e.g., during transport). Techniques and tools may differ based upon those
28 scenarios. The recommended practices will work toward ensuring that the sampling and testing is
29 representative of the bulk powder.
31 Organization(s): ASTM F42, ASTM B09, MPIF, SAE
1 Lifecycle Area: ☐Design; ☒Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished
3 Repair; ☐Data

6 Material Type: ☐All/Material Agnostic; ☒Metal; ☒Polymer; ☒Ceramic; ☐Composite
7 Process Category: ☐All/Process Agnostic; ☒Binder Jetting; ☒Directed Energy Deposition; ☐Material

11 Current Alternative: None
13 ☒New
14
15 New Gap PM12: Requirements for Large Storage and Transport Vessels of Powder Feedstock. Powder
16 produced for additive manufacturing is commonly sold in small metal or plastic containers in weights
17 able to be handled by operators. However, without complicated support equipment and workflows
18 using gloveboxes, the usage of such containers requires the feedstock to be exposed to atmosphere
19 upon introduction into an AM machine. Some users are beginning to request powder be loaded into
20 larger, reusable, metal containers by a supplier, refillable upon exhaustion. These portable storage
21 vessels act as transport, storage, and loading mechanisms into AM machines. Frequently these
22 containers are purged and backfilled with inert atmosphere, sometimes with onboard environmental
23 monitoring and control. No standardization for such vessels, their interfaces, or performance
24 requirements currently exists. Language for this document must be cognizant of DOT requirements (e.g.,
25 positive pressure).
26 R&D Needed: ☐ Yes; ☒ No; ☐Maybe
28 Recommendation: Write a requirements document for large storage and transport vessels of powder
29 feedstock.
31 Organization: ASTM, SAE
3 Repair; ☐Data


10 ☐Personnel/Suppliers; ☐Other (specify) ___
13 ☒New
14 Polymers
15 Proper handling of raw material (powder, pellet, or filament) is equally important for polymers. It is
16 important to address all of the following:
17  mitigation of exposure to powder and dust;

18  emission of volatile organic chemicals (VOC) during raw material storage, delivery, pre-
19 treatment, or in-process;
20  prevention of static electricity;
21  mitigation of environmental factors such as moisture and heat;
22  proper handling of powder or filament waste; and
23  exposure to nanomaterial component of specialty compound material.
24
25 Among the standards previously listed for metals, the ones most relevant to polymers are ANSI
26 Z400.1/Z129.1-2010, and NFPA 654-2020. In addition, NFPA 652-2019, Standard on the Fundamentals of
27 Combustible Dust could also provide additional guidelines for proper handling of polymer dust.
28 See also new gap PM12 on transport of large vessels.
29 2.2.1.2.1. Environmental Conditions: Effects on Materials

30
31 AM materials can be sensitive to changes in environmental conditions including temperature, humidity,
32 and ultraviolet radiation.
33
1 Published Standards. None identified.
3  ISO/ASTM DIS 52928, Additive manufacturing of metals— Feedstock materials — Powder life
4 cycle management
5
6 Gap PM13 (was Gap PC9 in v2): Environmental Conditions: Effects on Materials. General guidance is
7 needed to ensure the environmental conditions in which material is stored and used remain within
8 acceptable ranges for all material types. Specific material packaging requirements are addressed in
9 Section 2.2.1.2.
11 R&D Expectations: See recommendation
12 Recommendation: Develop guidance on the storage of AM materials and their need for protective
13 atmospheres so that AM materials are stored and used in environments with acceptable conditions.
14 Research should be conducted to identify these ranges.
16 Organization: ASTM F42/ISO TC 261, NIST, SAE, UL, Powder Manufacturers/Suppliers

19 Repair; ☐Data


29 ☐New
30 V3 Update: As noted in the text.
1 2.2.1.3 Characterization of Powders
2 Powder characteristics which are measured for other applications may not be sufficient for additive
3 manufacturing applications. Ensuring that precursor materials are fit for purpose presents a need for a
4 comprehensive understanding of their chemical composition, physical morphology and structure, and
5 mechanical, thermal, and other properties relevant to the AM process and the manufactured product.
6 Characterization is often referred to as a broad and general process by which the composition, structure
7 and properties are probed and measured. This often incudes several analytical techniques
8 (spectroscopic, microscopic, macroscopic) appropriate to the type of materials and the intended
9 purpose of the study. Provided below are some of the material characteristics influencing their handling,
10 AM process steps, and the finished product quality and integrity. A list of applicable test methods to
11 obtain the material information is listed, and possible gaps in the test method development are
12 identified.
13 2.2.1.3.1 Chemical Composition (metals, polymers, ceramics)

14
15 AM powder chemical characterization (including elemental composition, surface chemistry, chemically
16 reactive components, intermediate phases developed during the process, and trace elemental
17 impurities) is important to define the feedstock and therefore to determine the characteristics of built
18 parts. This is applicable equally for virgin and recycled feedstock for the AM process. Chemical
19 characterization may require a combination of conventional analytical methods on samples from various
20 stages in the AM process.
21 Metals
22 Equipment and standards for determining the composition of metal powders are the same as used in
23 the traditional metals industry for products such as cast/wrought mill products and powder metallurgy.
24 Nickel base and ferrous alloy powders have been produced for decades. A typical technique for
25 determining metallic element levels is X-ray spectroscopy. Residual elements often measured in part per
26 million (PPM) use mass spectrometers. Elements such as oxygen, hydrogen, and carbon use specialized
27 analyzers. All of these chemical testing processes are used worldwide.
28 Applicable standards and specifications include:
29  ASTM E353-19e1, Standard Test Methods for Chemical Analysis of Stainless, Heat-Resisting,
30 Maraging, and Other Similar Chromium-Nickel-Iron Alloys
31  ASTM E572-21, Standard Test Method for Analysis of Stainless and Alloy Steels by Wavelength
32 Dispersive X-Ray Fluorescence Spectrometry
33  ASTM E1019-18, Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and
34 Oxygen in Steel, Iron, Nickel, and Cobalt Alloys by Various Combustion and Inert Gas Fusion
35 Techniques
36  ASTM E1085-16, Standard Test Method for Analysis of Low-Alloy Steels by Wavelength
37 Dispersive X-Ray Fluorescence Spectrometry
1  ASTM E1479-16, Standard Practice for Describing and Specifying Inductively Coupled Plasma
2 Atomic Emission Spectrometers
3  ASTM E2465-19, Standard Test Method for Analysis of Ni-Base Alloys by Wavelength Dispersive
4 X-Ray Fluorescence Spectrometry
5  ASTM E2594-20, Standard Test Method for Analysis of Nickel Alloys by Inductively Coupled
6 Plasma Atomic Emission Spectrometry (Performance-Based)
7  ASTM E2823-17, Standard Test Method for Analysis of Nickel Alloys by Inductively Coupled
8 Plasma Mass Spectrometry (Performance-Based)
9  MPIF Standard Test Method 06, Method for Determination of Acid Insoluble Matter in Iron and
10 Copper Powders
11  MPIF Standard Test Method 66, Method for Sample Preparation for the Determination of the
12 Total Carbon Content of Powder Metallurgy (PM) Materials (excluding cemented carbides)
13  MPIF Standard Test Method 67, Guide to Sample Preparation for the Chemical Analysis of the
14 Metallic Elements in PM Materials (used for inductively coupled plasma, atomic absorption,
15 optical emission, glow discharge, and X-ray fluorescence spectrometers)
16 Applications using titanium alloy powder are emerging and the volume consumed is growing rapidly.
17 Chemical analysis techniques for titanium, as in the case of nickel base and ferrous alloys, are well
18 established. It is possible that over time revisions to procedures may be required due to the large
19 relative surface area of powder and reactivity of titanium with oxygen. However, existing specifications
20 and standards are working well.
21 Applicable standards and specifications include:
22  ASTM E539-19, Standard Test Method for Analysis of Titanium Alloys by Wavelength Dispersive
23 X-Ray Fluorescence Spectrometry
24  ASTM E1409-13(2021), Standard Test Method for Determination of Oxygen and Nitrogen in
25 Titanium and Titanium Alloys by Inert Gas Fusion
26  ASTM E1447-22, Standard Test Method For Determination Of Hydrogen In Reactive Metals And
27 Reactive Metal Alloys By Inert Gas Fusion With Detection By Thermal Conductivity Or Infrared
28 Spectrometry
29  ASTM E1941-10(2016), Standard Test Method for Determination of Carbon in Refractory and
30 Reactive Metals and Their Alloys by Combustion Analysis
31  ASTM E2371-21, Standard Test Method for Analysis of Titanium and Titanium Alloys by Direct
32 Current Plasma and Inductively Coupled Plasma Atomic Emission Spectrometry (Performance-
33 Based Test Methodology)
34
35 Test methods used to analyse the chemical composition of aluminum include the following:
36  ASTM E34-11e1, Standard Test Methods for Chemical Analysis of Aluminum and Aluminum-Base
37 Alloys
1  ASTM E1251-17a, Standard Test Method for Analysis of Aluminum and Aluminum Alloys by
2 Spark Atomic Emission Spectrometry
3  DIN EN 14242, Aluminium and aluminium alloys - Chemical Analysis - Inductively coupled plasma
4 optical emission spectral analysis
5 New Gap PM14: Test Method to Assess Hydrogen Content in Aluminum Powder Feedstocks.
6 Aluminum powder is commonly prone to the accumulation of both moisture and surface salts that affect
7 produced parts via supersaturation of hydrogen upon consolidation via additive manufacturing.
8 Supersaturation of hydrogen within consolidated material may result in material defects such as
9 hydrogen pores at the time of fabrication or hydrogen pore formation with subsequent welding (or
10 other high temperature processing). Measurement of hydrogen content is one method to assess the
11 potential for such deleterious material behavior before usage of powder feedstock. Assessing the
12 hydrogen concentration within and on the surface of aluminum powders requires both a test method
13 and an available calibration standard specimen.
14 R&D Needed: ☒ Yes; ☐ No; ☐Maybe
15 R&D Expectations: Feasibility of developing a commercially available test specimen for calibrating the
16 test method. Also, determine if low concentrations are repeatably detectable. Establishing hydrogen
17 thresholding also would be desirable.
18 Recommendation: Develop a test method to spur industry to generate calibration samples and/or
19 specialized test equipment.
21 Organization: ASTM

24 Repair; ☐Data

27 Material Type: ☐All/Material Agnostic; ☒Metal; ☐Polymer; ☐Ceramic; ☐Composite
28 Process Category: ☐All/Process Agnostic; ☐Binder Jetting; ☐Directed Energy Deposition; ☐Material

31 ☐Personnel/Suppliers; ☐Other (specify) ___
2 ☒ New
3 The chemical compositions of material specifications currently lack information for non-critical elements
4 and their level of impurities.
6  ISO 17034:2016, General requirements for the competence of reference material producers
7  SAE AMS2280D, Trace Element Control Nickel Alloy Castings (2019-11-05)
8 No in development standards have been identified.
9 New Gap PM15: Identification and Quantification of Impurities in Chemical Compositions. There is a need
10 to identify the level of impurities in material chemical compositions.
13 Recommendation: Develop a standard to identify, quantify and report the level of impurities in chemical
14 composition of material specifications for critical and non-critical elements.
16 Organization(s): ISO, ASTM

19 Repair; ☐Data


2 ☒New
3 Polymers
4 Specifications and standards are well established to determine molecular weight of polymers, structure,
5 chemistry of fractions, end groups, tacticity, unreacted monomer and oligomers, co-polymer content
6 and blend composition, catalyst residues, contamination analysis, chemical trace analysis and polymers
7 volatile organic compounds. It is necessary to consider the utilization of recycled materials in AM
8 applications which use thermoplastic polymer precursors to ensure their conformance to all
9 requirements.
11  ASTM WK75265. Guide for Additive Manufacturing of Polymers -- Powder Bed Fusion --
12 Guidelines for Feedstock Recycling and Sampling Strategies
13
14 Gap PM8: Use of Recycled Polymer Precursor Materials. Feedstock/precursor material can be sourced
15 from either virgin polymer resin, recycled polymer resin, or a combination of the two. Recycled resin can
16 be obtained from a number of different sources including in-house processed product of the same
17 material which may not have met all the requirements when initially produced but is still functional,
18 commercial recyclate from commercial sources, and post-consumer recyclate. Recycled feedstock,
19 depending on its source and usage level, can introduce problems in the printing or end-use application
20 due to the recyclate’s thermal/mechanical history, consistency and composition.
22 R&D Expectations: To determine the acceptable limits and other constraints of incorporating
23 reprocessed materials. This may be machine, material, and/or application specific.
24 Recommendation: Develop a general guidance document to address best practices in regard to sources,
25 handling, and characterization of recycled materials. In some cases, such as medical and aerospace
26 applications, more stringent guidelines may need to be developed such as identification of recycled
27 material use. Complete standards development in ASTM WK75265.
29 Organization: ASTM F42/D20, SAE AMS-AM

32 Repair; ☐Data
3 Material Type: ☐All/Material Agnostic; ☐Metal; ☒Polymer; ☐Ceramic; ☐Composite

8 Current Alternative: The aerospace and medical sectors need to demonstrate compliance to
9 requirements. Organizations use their own internal practices.
11 New
12
13 Ceramics
14 Ceramic chemical composition is not a significant issue for ceramic additive manufacturing because
15 most ceramic compositions are stable and will not change during the additive manufacturing process.
16 Ceramic composition is important in post-processing, such as sintering. The sintering process is the same
17 as for a conventional ceramic process. There are no specific chemical composition issues for ceramics
18 that need to be addressed. Industries have well established their own chemical composition control
19 frameworks. Standard test methods have been used for ceramic composition determinations.
20 Most ceramics are stable during additive manufacturing, while some non oxide ceramics can be oxidized
21 during storage, the additive manufacturing process, and post-processing. However, this only affects the
22 post-processing sintering process. The oxidation behavior is like a conventional ceramic process. There is
23 no specific need to be addressed for additive manufacturing.
24 Some unmatured ceramic additive manufacturing technologies, such as laser and E-beam direct melting,
25 will be affected by ceramic compositions. The composition changes the melting temperature and that
26 affects the process significantly.
27 Since ceramic additive manufacturing involves polymer binders, the binder composition is significant for
28 the ceramic additive manufacturing process. For binder composition, refer to the polymer composition
29 section.
30 2.2.1.3.2 Flowability
31
1 The materials used in AM are often required to flow. The performance of these materials, in regards to
2 their flowability, must be characterized.

5 metallic powders
6
7 Identified published standards not specific to AM include:
8  ASTM B213-20, Standard Test Methods for Flow Rate of Metal Powders Using the Hall
9 Flowmeter Funnel
10  ASTM B855-17, Standard Test Method for Volumetric Flow Rate of Metal Powders Using the
11 Arnold Meter and Hall Flowmeter Funnel
12  ASTM B964-16, Standard Test Methods for Flow Rate of Metal Powders Using the Carney Funnel
13  ASTM D1895-17, Standard Test Methods for Apparent Density, Bulk Factor, and Pourability of
14 Plastic Materials
15  ASTM D7891-15, Standard Test Method for Shear Testing of Powders Using the Freeman
16 Technology FT4 Powder Rheometer Shear Cell
17  ISO 4490:2018, Metallic powders – Determination of flow rate by means of a calibrated funnel
18 (Hall flowmeter)
19  MPIF Standard Test Method 03, Method for Determination of Flow Rate of Free-Flowing Metal
20 Powders Using the Hall Apparatus
21
23  ASTM WK55610, New Test Methods for the Characterization of Powder Flow Properties for
24 Additive Manufacturing Applications (formerly WK49272), being jointly developed as JG 63 by
25 ISO/TC261 and ASTM F42
26  ASTM WK66030, New Guide for Quality Assessment of Metal Powder Feedstock
27 Characterization Data for Additive Manufacturing (F42.01)
28  ASTM WK71393, New Practice for Additive manufacturing -- assessment of powder spreadability
29 for powder bed fusion (PBF) processes (F42.01)
30  ISO/ASTM DTR 52913-1, Additive manufacturing — Feedstock materials — Part 1: Parameters
31 for characterization of powder flow properties
32  ISO/ASTM DTR 52952, Additive Manufacturing of metals — Feedstock materials — Correlating
33 of rotating drum measurement with powder spreadability in PBF-LB machines
34
35 Gap PM1: Flowability. Existing standards for flowability do not account for the range of conditions that
36 a powder may encounter during AM processes.
37 R&D Needed: ☒Yes; ☐ No; ☐Maybe
1 R&D Expectations: R&D is needed to collect data as a useful metric regarding flowability, especially
2 with powder bed processing. Current test methods do not represent the flow behavior inside of an AM
3 process, at best correlative but not representative. ASTM AM CoE Strategic Roadmap for Research &
4 Development (April 2020) notes that AM CoE Project 1803 (WK66030) addresses AMSC gap PM1.
5 Recommendation: Standards are needed to address test methods which encompass the variety of flow
6 regimes encountered in AM processes. Recommend completion of ASTM WK55610, New Test Methods
7 for the Characterization of Powder Flow Properties for Additive Manufacturing Applications, (not specific
8 to metal powders) which addresses dynamic flow, aeration, permeability, consolidation and
9 compressibility test procedures using, for example, a powder rheometer. See also gap PC12 on
10 precursor material flow monitoring.
12 Organization: ASTM F42/ISO TC 261, NIST, ASTM B09, ASTM E29

15 Repair; ☐Data


23 Current Alternative: There are no known alternatives.
25 ☐New
26 V3 Update: As noted in the text, ASTM WK55610 is in development. Completion of those work items
27 may partially but not fully address the gap.
28 2.2.1.3.3 Spreadability
29
30 Multiple AM processes involve the spreading of powder; however, there are no AM standards specifying
31 how to quantitatively assess powder spreadability.

3 metallic powders
4
6  ASTM WK55610, New Test Methods for the Characterization of Powder Flow Properties for
7 Additive Manufacturing Applications. This draft document addresses shear and dynamic flow
8 properties but does not directly address spreadability. In terms of shear properties, the draft
9 document points to existing ASTM standards for shear cell tests and wall friction tests (ASTM
10 D6128-22, D6773-22, and D7891-15).
13  ASTM WK71393, New Practice for Additive manufacturing -- assessment of powder spreadability
14 for powder bed fusion (PBF) processes
15  ISO/ASTM DTR 52913-1, Additive manufacturing — Feedstock materials — Part 1: Parameters
16 for characterization of powder flow properties
17  ISO/ASTM DTR 52952, Additive Manufacturing of metals — Feedstock materials — Correlating
18 of rotating drum measurement with powder spreadability in PBF-LB machines
19
20 Gap PM2: Spreadability. There is no known description of spreadability or standard for how to
21 quantitatively assess powder spreadability.
23 R&D Expectations: R&D is needed to (1) measure and quantify spreadability (direct measurement /
24 scoring value) and (2) to correlate powder characteristics with spreadability (performance metric via a
25 combination of measurements of intrinsic properties).
26 Recommendation: A standard should be created that guides the measurement of a powder’s

27 spreadability. This standard may be comprised of a series of tests that together describe a powder’s
28 spreading performance.
29 Priority: ☐High; ☒Medium (direct measurement); ☒Low (characterization aspects)
30 Organization: ASTM F42/ISO TC 261, NIST, universities, ASTM B09, ASTM E29
31 Lifecycle Area: ☐Design; ☒Precursor Materials; ☒Process Control; ☐Post-processing; ☐Finished

33 Repair; ☐Data

1 Material Type: ☒ All/Material Agnostic; ☐ Metal; ☐Polymer; ☐Ceramic; ☐Composite
2 Process Category: ☐All/Process Agnostic; ☒Binder Jetting; ☐Directed Energy Deposition; ☐Material

6 Current Alternative: None known for powder spreadability specifically. A combination of flowability
7 methods, moisture content, PSD, particle morphology could be loosely applied but is not a direct
8 alternative.
9 V3 Status of Progress: ☒Green (metals) ; ☐Yellow; ☐Red; ☒Not Started (other materials); ☐Unknown;
10 ☐Withdrawn; ☐Closed; ☐New
11 V3 Update: ASTM WK71393 is focused on the assessment of powder spreadability for metals. Polymer
12 and ceramic standards and the 2nd part of the recommendation on the performance metrics have not
13 begun.
14 2.2.1.3.4 Density (Apparent vs. Tapped)

15
16 The powder deposition has a large effect on the quality of a final AM part. Therefore, the loose
17 (apparent) density as well as the consolidated (tapped) density must be known.
19  ASTM B212-21, Standard Test Method for Apparent Density of Free-Flowing Metal Powders
20 Using the Hall Flowmeter Funnel
21  ASTM B527-20, Standard Test Method for Tap Density of Metal Powders and Compounds
22  ISO 3923-1:2018, Metallic powders - Determination of apparent density - Part 1: Funnel method
23  ISO 3953:2011, Metallic powders - Determination of tap density
24  MPIF Standard Test Method 46, Method for Determination of Tap Density of Metal Powders
25  MPIF Standard Test Method 04, Method for Determination of Apparent Density of Free-Flowing
26 Metal Powders Using the Hall Apparatus
27
28 Existing standards are likely sufficient for guiding the measurement of the tapped and apparent density
29 of AM powders. No standards in development and no gaps have been identified at this time.
30 2.2.1.3.5 Particle Size and Particle Size Distribution

31
32 Particle size and particle size distribution are critical to the outcome of the AM build. The size of
33 particles and distribution requirements are specific to the powder deposition process and to the fusion
34 mechanism.
1 The particle size will be limited to achieve the appropriate temperature at the particle core. Particle size
2 must also be chosen appropriate to the layer thickness of the build process. While some systems allow
3 for variation in the layer thickness to accommodate various sized powders (directed energy systems
4 tend to be more flexible in terms of the layer thickness than powder bed systems), thinner layers lead to
5 better resolution. Typically, finer powders do not flow as well as those with larger particle size.
7 There are a number of measurement techniques for determining particle size, including dry sieving,
8 laser diffraction, and image analysis via optical or scanning electron microscope.
9  ASTM F3049-14(2021), Standard Guide for Characterizing Properties of Metal Powders Used for
10 Additive Manufacturing Processes, addresses measurement techniques for particle size, making
11 use of references to existing powder size measurement methods that exist for powder
12 metallurgy.
13
14 AM-specific powder metallurgy standards include the following:
15
16  ASTM F3560-22 Standard Specification for Additive Manufacturing – Data – Common Exchange
17 Format for Particle Size Analysis by Light Scattering
19 metallic powders
20  SAE AMS7025, Metal Powder Feedstock Size Classifications
21
22 A number of powder metallurgy standards exist that are not AM-specific but that can be applied to AM
23 powders. Such standards include but are not limited to:
24
25  ASTM B214-16, Standard Test Method for Sieve Analysis of Metal Powders
26  ASTM B215-20, Standard Practices for Sampling Metal Powders
27  ASTM B822-20, Standard Test Method for Particle Size Distribution of Metal Powders and
28 Related Compounds by Light Scattering
29  ISO 9276 Parts 1-6, Representation of results of particle size analysis
30  ISO 13320:2020, Particle size analysis — Laser diffraction methods
31  ISO 13322-1:2014, Particle size analysis — Image analysis methods — Part 1: Static image analysis
32 methods
33  ISO 13322-2:2021, Particle size analysis — Image analysis methods — Part 2: Dynamic image
34 analysis methods
35  MPIF Standard Test Method 32, Methods for Estimating Average Particle Size of Metal Powders
36 Using Air Permeability
37
38 In Development Standards (AM-Specific)
3  ASTM WK78812, New Test Method for Measurement of Particle Size and Shape of Additive
4 Manufacturing Base Materials by Dynamic Imaging Analyzers (B09.02)
5
6 New Gap PM16: Universal Reference Standard on Size Distribution. No current product is recognized as
7 a universal reference standard to establish comparisons on precision and accuracy of measurement
8 methods and equipment when assessing particle size distribution. If no one single reference standard is
9 available, a document to relate the results of using different standards for specific, respective tools
10 should be drafted.
11
13 R&D Expectations: Validation of various measurement techniques for reliability, repeatability, and
14 correlation is required when using a proposed reference standard. If none is determined suitable, then a
15 working relationship between different standards and their corresponding measurement method should
16 be generated.
17 Recommendation: See R&D Expectations
19 Organization(s): ASTM F42, ASTM B09, MPIF

22 Repair; ☐Data


2 ☒New
4 New Gap PM17: Error Quantification of PSD Measurement Methods. Round robin and/or analytical
5 examination and uncertainty quantification related to the sources of error for different measurement
6 methods/techniques should be critically examined and documented in a guidance document or
7 standard.
9 R&D Expectations: Establish effective repeatability and systematic error associated with measurement
10 methods commonly used in industry. Understand reproducibility, i.e., the sources of error that are
11 introduced by differences in operators, equipment, and techniques.
12 Recommendation: See R&D Expectations
14 Organization(s): ASTM F42, ASTM B09, MPIF

17 Repair; ☐Data


27 ☒New
28 2.2.1.3.6 Particle Morphology
1
2 Particle shape and surface quality affect flow characteristics as well as packing density. Smooth spherical
3 particles provide less resistance to flow than non-spherical particles or those with a rough surface.
4 Light scattering techniques and image analysis can be used to observe particle morphology. These
5 techniques provide a basis for qualitative comparison of powder lots. However, they do not allow for
6 detection of hollow particles, which are important to detect as their presence may lead to porosity in
7 the built parts.
9 There are no AM-specific standards describing how to quantitatively assess particle morphology. There
10 is a specification for general powder metallurgy, ASTM B243-22, Standard Terminology of Powder
11 Metallurgy, that defines typical powder shapes. ASTM B09 is planning to add AM-specific terms to B243.
12 In addition, ISO 9276-6:2008, Representation of results of particle size analysis – Part 6: Descriptive and
13 quantitative representation of particle shape and morphology, provides rules and nomenclature for
14 describing and quantitatively representing particle morphology. Other relevant published standards
15 include:
16  ASTM F3571-22, Guide for Additive Manufacturing Feedstock Particle Shape Image Analysis by
17 Optical Photography to Identify and Quantify the Agglomerates/Satellites in Metal Powder
18 Feedstock (previously WK74905)
20 metallic powders
21  ISO 13322-1:2014, Particle size analysis — Image analysis methods — Part 1: Static image analysis
22 methods
23  ISO 13322-2:2021, Particle size analysis — Image analysis methods — Part 2: Dynamic image
24 analysis methods
25
29  ASTM WK78812, New Test Method for Measurement of Particle Size and Shape of Additive
30 Manufacturing Base Materials by Dynamic Imaging Analyzers (B09.02)
31
32 Gap PM4: Particle Morphology. There is a need for AM-specific standards describing how to
33 quantitatively assess particle morphology.
35 R&D Expectations: R&D is needed to measure and quantify particle morphology as well as determine
36 impacts to process performance. ASTM AM CoE Strategic Roadmap for Research & Development (April
37 2020) notes that AM CoE Project 1803 (WK66030) addresses AMSC gap PM4.
1 Recommendation: Based on the results of R&D, a terms, definitions and taxonomy (which can assist
2 with categorizations and define appropriate/inappropriate uses) standard may be needed for powder
3 morphology and criteria for determining acceptable powder morphology characteristics. Because
4 powder morphology may affect powder flow, powder spreadability, and density of the AM built object,
5 it could possibly be addressed indirectly by standards governing flow and spreadability requirements for
6 a powder, taking into account the density of the powder. Upon completion of this, additional
7 standardization work can be determined.
9 Organization: NIST, ASTM F42/ISO TC 261 JG 66, ASTM B09, ASTM E29

12 Repair; ☒Data

18 Q&C Category: ☒Materials; Processes/Procedures; ☐Machines/Equipment; ☐Parts/Devices;

22 ☐New
23 V3 Update: As noted, ISO/ASTM 52907 has been published.
24 2.2.1.3.7 Feedstock Sampling

25
26 Control of powder is key to obtaining consistent and predictable properties of AM objects. Metrics for
27 assessing powder characteristics depend upon testing of a representative sample. Considerations for
28 powder sampling include:
29  Methods of retrieval of a sample from a powder batch to ensure a random and representative
30 sample is taken.
31  Quantity of powder to be sampled, possibly as a function of total batch size.
1  Frequency at which to sample the powder, including how long the powder can be stored prior to
2 use before necessitating repeat sampling.
3  Requirements for sampling of reused powder and of blends/mixtures of different powder
4 batches, in the case where the original powders were sampled. See also section 2.2.1.4 on
5 precursor material handling: use, reuse, mixing, and recycling feedstock.
7  ASTM B215-20, Standard Practices for Sampling Metal Powders

9 Additive Manufacturing Processes, which references existing powder metallurgy sampling
10 practices covered in ASTM B215
12 metallic powders
13  ISO/ASTM 52925:2022, Additive manufacturing of polymers — Feedstock materials —
14 Qualification of materials for laser-based powder bed fusion of parts
15  ISO 3954:2007, Powders for powder metallurgical purposes—Sampling
16  MPIF Standard Test Method 01, Method for Sampling Metal Powders (2022), which is the
17 equivalent standard to ASTM B215
18  SAE AMS7003A, Laser Powder Bed Fusion Process (2022-08-05), contains requirements for
19 feedstock powder handling and storage plan.
20
23 Characterization Data for Additive Manufacturing
25 cycle management
26 Gap PM5: Metal Powder Feedstock Sampling. Existing powder metallurgy standards may be leveraged
27 for AM use; however, they require tailoring for AM-specific situations, such as the following:
28 1) sampling practices for a reused powder that has been through an AM build cycle are needed to
29 establish how to collect representative powder samples. These practices should take into account the
30 variation caused by build exposure on powder in multiple locations.
31 2) sampling practices for preparation of small samples (e.g., 15 mg to 20 mg for scanning by electron
32 microscopy) need to be established, including prescribing an acceptable percentage of powder lost
33 during processing. For example, the powder particles can in some cases stick to the vials depending on
34 the equipment used.
36 R&D Expectations: With respect to the reuse of powder during the build. See also gap PM18.
1 Recommendation: Standards are needed for sampling of powders used for AM, with considerations for
2 unique aspects of AM not considered in powder sampling standards for general powder metallurgy,
3 including reuse of powder.
5 Organization: NIST, SAE AMS-AM, ASTM B09, MPIF, ASTM D20 (for polymers), ASTM F42, ASTM E29

8 Repair; ☐Data


16 Current Alternative: Internally developed best practices
18 ☐New
19 V3 Update: Recently published and/or updated standards and standards in development are noted
20 above.
21 2.2.1.3.8 Hollow Particles and Hollow Particles with Entrapped Gas
22 The fitness-for-use requirements of metal powders for additive manufacturing differ from traditional
23 metal powder applications. One area is the potential impact of the presence of hollow particles and
24 hollow particles with entrapped gas that occurred during the atomization process. Hollow particles and
25 hollow particles with entrapped gas may exist in metal powder lots regardless of the powder making
26 and atomization processes and therefore may be an uncontrolled variable.
28  ASTM B311-17, Test Method for Density of Powder Metallurgy (PM) Materials Containing Less
29 Than Two Percent Porosity
30  ASTM B796-20, Standard Test Method for Nonmetallic Inclusion Content of Ferrous Powders
31 Intended for Powder Forging (PF) Applications
1  ASTM B922-22, Standard Test Method for Metal Powder Specific Surface Area by Physical
2 Adsorption
3  ASTM B923-22, Standard Test Method for Metal Powder Skeletal Density by Helium or Nitrogen
4 Pycnometry
5  ISO 13947:2011, Metallic Powders - Test Method For The Determination Of Non-Metallic
6 Inclusions In Metal Powders Using A Powder-Forged Specimen
7
8 The above standards do not address the measurement of powder inclusions or closed porosity
9 measurements for AM specific applications.
10 Other published standards include:

12 metallic powders
13
14 The following methods are currently used in R&D to determine internal powder porosity:
15  Gas and liquid pycnometry – Measurement of True Density of powders. Method suitable for
16 powders where a large fraction of the population has porosity. Also, suitable for single element
17 composition exact mixtures. Variation in alloy composition decreases measurement accuracy.
18 Do not obtain pore size distribution.
19  Metallography with image analysis – Suitable for powder where a large fraction of the
20 population has porosity. Limited by large number of measurements needed for accurate
21 statistics.
22  CT with image analysis – Bulk analysis for powder porosity.
23  Ultrasonic Non-Destructive Testing (NDT) – Suitable for bulk materials. Development of
24 experimental database for powder is needed.
25
26 Research on powder porosity measurement techniques has been conducted at NIST, industrial labs, and
27 universities.
28 There are no ASTM, ISO, or MPIF standards for measuring internal powder porosity/inclusions for AM
29 specific applications.
30 Gap PM6: Hollow Particles and Hollow Particles with Entrapped Gas. No standards exist for measuring
31 how to determine the presence and percentage of hollow particles and hollow particles with entrapped
32 gas or their impact upon part properties and in-service performance.
34 R&D Expectations: R&D is needed to establish the impact of hollow powder particles, if any.
35 Recommendation: Dependent upon R&D, a standard may be needed that specifies how to determine
36 the percentage of hollow particles and hollow particles with entrapped gas in lots of metal powders.
1 Testing may be needed to determine the level of hollow particles and hollow particles with entrapped
2 gas that are acceptable without negatively affecting the properties and performance of finished parts.
4 Organization: For R&D: NIST, ASTM, America Makes, Oak Ridge National Laboratory, universities. For
5 standards: ASTM F42/ISO TC 261, SAE, ASTM B09, ASTM E29

8 Repair; ☐Data

11 Material Type: All/Material Agnostic; ☒Metal; ☐Polymer; ☐Ceramic; ☐Composite

17 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐Not Started; ☒Unknown; ☐Withdrawn; ☐Closed;
18 ☐New
19 V3 Update: None provided
20 2.2.1.3.9 Metal Powder Specifications for Procurement Activities in Support of AM
21 Currently, most manufacturers of AM equipment also offer metal powder for purchase. In fact, they
22 provide data containing representative final material properties for parts created using both their
23 equipment and powder.
25  ASTM F2924-14(2021), Standard Specification for Additive Manufacturing Titanium-6 Aluminum-

26 4 Vanadium with Powder Bed Fusion
28 4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
29  ASTM F3055-14a(2021) Standard Specification for Additive Manufacturing Nickel Alloy (UNS
30 N07718) with Powder Bed Fusion
1  ASTM F3056-14(2021) Standard Specification for Additive Manufacturing Nickel Alloy (UNS
3  ASTM F3184-16, Standard Specification for Additive Manufacturing Stainless Steel Alloy (UNS
4 S31603) with Powder Bed Fusion
5  ASTM F3213-17, Standard for Additive Manufacturing – Finished Part Properties – Standard
6 Specification for Cobalt-28 Chromium-6 Molybdenum via Powder Bed Fusion
7  MPIFStd35, Materials Standards for PM Structural Parts
9 62Ni - 21.5Cr - 9.0Mo - 3.65 Nb (2018-06-08)
10  SAE AMS7002A, Process Requirements for Production of Metal Powder Feedstock for Use in
11 Additive Manufacturing of Aerospace Parts (2022-05-16)
12  SAE AMS7006, Nickel Alloy, Corrosion- and Heat-Resistant, Powder for Additive Manufacturing
13 52.5Ni - 19Cr - 3.0Mo - 5.1Cb (Nb) - 0.90Ti - 0.50Al - 18Fe (2022-03-21)
15 47.5Ni - 22Cr - 1.5Co - 9.0Mo - 0.60W - 18.5Fe (2019-03-26)
16  SAE AMS7012, Precipitation Hardenable Steel Alloy, Corrosion and Heat-Resistant Powder for
17 Additive Manufacturing 16.0Cr - 4.0Ni - 4.0Cu - 0.30Nb (2019-11-14)
19 60Ni - 22Cr - 2.0Mo - 14W - 0.35Al - 0.03La (2019-01-03)
20  SAE AMS7014, Titanium Alloy, High Temperature Applications, Powder for Additive
21 Manufacturing, Ti - 6.0Al - 2.0Sn - 4.0Zr - 2.0Mo (2019-03-11)
22  SAE AMS7015, Titanium 6-Aluminum 4-Vanadium Powder for Additive Manufacturing (2022-04-
23 22)
24  SAE AMS7017 Titanium 6 - Aluminum 4 - Vanadium Powder for Additive Manufacturing, Extra
25 Low Interstitial (ELI) (2022-04-07)
26  SAE AMS7018, Aluminum Alloy Powder 10.0Si – 0.35Mg (2020-05-11)
27  SAE AMS7020, Aluminum Alloy Powder 7.0Si - 0.55Mg - 0.12Ti (2021-11-09)
28  SAE AMS7021, Precipitation Hardenable Steel Alloy, Corrosion and Heat Resistant, Powder for
29 Additive Manufacturing, 15.0Cr - 4.5Ni - 3.5Cu - 0.30Nb (2020-11-19)
30  SAE AMS7023, Gamma Titanium Aluminide Powder for Additive Manufacturing, Ti - 48Al - 2Nb -
31 2Cr (2021-06-01)
32  SAE AMS7025, Metal Powder Feedstock Size Classifications (2021-04-22)
33  SAE AMS7026, Titanium Ti-5553 (Ti - 5Al - 5Mo - 5V - 3Cr) Powder for Additive Manufacturing
34 (2021-07-28)
35  SAE AMS7033, Aluminum Alloy Powder, 4.6Cu - 3.4Ti - 1.4B - 0.75Ag - 0.27Mg (2021-06-22)
36  SAE AMS7035, Precipitation Hardenable Steel Alloy, Corrosion and Heat-Resistant, Powder for
37 Binder Jet Additive Manufacturing, 16.0Cr – 4.0Ni – 4.0Cu -0.30Nb (2021-06-22)
38  SAE AMS7037, Steel, Corrosion and Heat-Resistant, Powder for Additive Manufacturing, 17Cr -
39 13Ni - 2.5Mo (316L) (2021-11-23)
40
1  SAE AMS7012A, Precipitation Hardenable Steel Alloy, Corrosion and Heat-Resistant Powder for
3  SAE AMS7045, Aluminum Alloy Powder, 5.3Zn – 3.3Mg - 1.7Zr – 1.6Cu (Composition Similar to
4 7A77.50) (2022-01-14)
5  SAE AMS7047, Low Alloy, Medium Carbon Steel Powder for Binder Jet Additive Manufacturing,
6 1.0Cr – 0.20Mo – 0.30C (Composition Similar to UNS G41300) (2022-01-14)
7  SAE AMS7054, Aluminum alloy powder A6061-RAM2 (2022-12-22)
8  SAE AMS7055, Precipitation Hardenable Steel Alloy Powder for Additive Manufacturing (2023-
9 01-18)
10
11 Gap PM7: Metal Powder Specifications for Procurement Activities in Support of AM. There is a need
12 for more specifications to inform procurement decisions and establish requirements and acceptance
13 criteria of metal powder for purposes of quality assurance.
15 R&D Expectations: R&D is needed to determine the effect of powder parameters/characteristics on final
16 part properties and on the suitability of a given powder for use in a given AM machine. Some of these
17 powder parameters may include:
18 1) Particle Size Distribution

19 2) Particle Morphology
20 3) Flow Rate
21 4) Tap Density
22 5) Angle of Repose
23 6) Shear Stress
24 7) Chemistry
25 8) Specific Surface Area
26
27 ASTM AM CoE Strategic Roadmap for Research & Development (April 2020) notes that AM CoE Project
28 1803 (WK66030) addresses AMSC gap PM7.
29 Recommendation: Develop specifications to facilitate procurement of metal powders for use in AM

30 machines.
32 Organization: ISO/ASTM, SAE AMS-AM, AWS, industry OEMs

35 Repair; ☒Data
1 Sectors: ☐All/Sector Agnostic; ☒Aerospace; ☐Automotive; ☐Construction; ☒Defense; ☐Electronics;

10 ☐New
11 V3 Update: Recently published standards and projects started are noted in the text.
12 2.2.1.4 Precursor Material Handling: Use, Reuse, Mixing, and Recycling Feedstock
13 Handling of feedstock materials during the manufacturing process must be controlled to minimize, if not
14 eliminate, the risk of contamination and product defects. Storage and shipment of feedstock material
15 should also meet the precursor material requirements and protect these properties throughout its shelf
16 life. Mixing and reuse of materials must meet the precursor material requirements. Similarly, handling of
17 unused material is a critical enabler for product quality and reuse or recycle in subsequent additive part
18 production. One cannot assume that material at the end of an additive process meets precursor
19 material requirements or is otherwise qualified for production. See also section 2.2.1.3.7 on feedstock
20 sampling.
23 Medical Applications for Additive Manufacturing Feedstock Materials
24  SAE AMS7031, Batch Processing Requirements for the Reuse of Used Powder in Additive
25 Manufacturing of Aerospace Parts (2022-03-29)
26  SAE ARP7044 - Powder History Scoring Metric and Labeling Schema (2022-11-22)
27
29  ASTM WK75184, New Guide for Additive Manufacturing of Metals -- Powder Bed Fusion --
31  ASTM WK75265, New Guide for Additive Manufacturing of Polymers -- Powder Bed Fusion --
1  ISO/ASTM DIS 52928, Additive manufacturing of Metals — Feedstock materials — Powder life
2 cycle management
3  SAE AMS7052, Continuous, Closed-Loop Process Requirements for the Reuse of Used Powder in
5
6 Gap PM18 (was Gap PC7 in v2): Recycle & Reuse of Materials. There are many practices in the
7 materials industry of how to recycle, reuse, and revert materials in production. They are also highly
8 material dependent. Processes to prepare used powder for reuse can currently only be verified against
9 precursor material specifications defined in their virgin state.
11 R&D Expectations: Research should be conducted on testing conditions, properties of concern, and
12 feedstock usage history, to understand the effects of using reused material.
13 Recommendation: Develop guidance built upon published evidence from white papers as to whether
14 and how reused material may be used when assessed for metrics such as number of build cycles, build
15 cycle exposure time, or some other metric. Parts made from this reused material should factor in such
16 aspects as part criticality, redundancy, environmental conditions, etc. Considerations should be made as
17 to whether the feedstock has been exposed to a build cycle of the AM process or exited the container it
18 was delivered in at the virgin state.
20 Organization: ASTM F42/ISO TC 261, ASTM D20, AWS, MPIF, NIST, SAE, trusted end user-group

23 Repair; ☐Data


2 ☐New
3 V3 Update: Published standards and standards in development are noted in the text.
4 2.2.1.4.1 Terminology Related to Reuse of Feedstock Materials
5 Industry tends to use terms interchangeably and inconsistency when it comes to powder reuse.
6 Conformance to requirements is key regardless of whether or not powder has been used.
8 General terminology standards include:

9
12  ISO/ASTM 52900:2021, Additive manufacturing – General principles – Terminology, contains the
13 following terms and definitions: Material supplier; Feedstock; Part cake; Batch; Powder blend;
14 Lot; Used powder.
17
19  ASTM WK75184, New Guide for Additive Manufacturing of Metals -- Powder Bed Fusion --
21  ASTM WK75265, New Guide for Additive Manufacturing of Polymers -- Powder Bed Fusion --
23  ISO/ASTM DIS 52928, Additive manufacturing of Metals — Feedstock materials — Powder life
24 cycle management
27
28 New Gap PM19: Terminology Related to Reuse of Feedstock Materials. Define terms that today are in
29 practice that may establish a common vocabulary for metallic, polymer, ceramic feedstock materials. A
30 dictionary may include different definitions for the same terms based on the material class.
1 Recommendation: Do a side by side comparison between existing published standards on how to
2 interpret terms and definitions as they relate to their corresponding documents and why they are
3 different.
5 Organization(s): ISO/ASTM, SAE, MPIF

8 Repair; ☐Data


16 Current Alternative: Individual documents where defined. For example, ISO/ASTM 52900, SAE
17 AMS7031, SAE AMS7044
19 ☒New
20 2.2.1.5 Characterization of Material Extrusion Feedstock (Filaments & Pellets)
21 Filaments are produced by extruding plastic pellets or powders (generally derived from ground pellets)
22 into the appropriate filament geometry required for the AM process in which the filaments are
23 reheated, melted, and deposited onto the build. Pellet feedstock for AM processing is a variant which
24 eliminates the need to produce filaments and relies on the direct feeding, heating, and melting of the
25 plastic as part of the AM process. In most cases, these are fully formulated materials containing
26 appropriate stabilizers and other components as required. The chemical requirements for filament
27 feedstock and pellet feedstock could be identical but the physical requirements are different.
28 2.2.1.5.1 Chemical Composition
29 Chemical characterization (including composition, molecular weight of polymers, chemical structure, co-
30 polymer content and blend composition, impurity content, formulation, and polymers volatile organic
1 compounds) is important to define the feedstock and therefore to determine the characteristics of built
2 parts. This is applicable equally for virgin and recycled feedstock for the AM process, see gap PM8.
4  ASTM D4000-20, Standard Classification System for Specifying Plastic Materials

5  Specific ASTM Material classification documents (per D4000), for example:
6  ASTM D6779-21, Standard Classification System for and Basis of Specification for Polyamide
7 Molding and Extrusion Materials (PA)
8  ASTM D4101-17e1, Standard Classification System and Basis for Specification for
9 Polypropylene Injection and Extrusion Materials
10  SAE AMS7101A, Material for Fused Filament Fabrication (2022-07-08)
11
12 2.2.1.5.2 Geometry
13 The geometry of the filament or pellets can affect how well the material will process and can affect the
14 final AM part density and fill, as well as the potential for defects. The geometry needed is very
15 dependent and will be defined by the individual OEM machine.
16 2.2.1.5.3 Melt Flow
17 The materials used in material extrusion are required to melt and flow through a nozzle to be deposited
18 on the build. The performance of these materials, in regards to their flow, must be characterized. They
19 are typically characterized by their rheological (melt) and thermal properties.
21  ASTM D1238-23, Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion
22 Plastometer
23  ASTM D3418-21, Standard Test Method for Transition Temperatures and Enthalpies of Fusion
24 and Crystallization of Polymers by Differential Scanning Calorimetry
25  ASTM D4440-15, Standard Test Method for Plastics: Dynamic Mechanical Properties Melt
26 Rheology
27  ASTM D7028-07(2015), Standard Test Method for Glass Transition Temperature (DMA Tg) of
28 Polymer Matrix Composites by Dynamic Mechanical Analysis (DMA)
29  ISO/ASTM 52903-1:2020, Additive manufacturing – Material extrusion-based additive
30 manufacturing of plastic materials – Part 1: Feedstock materials
32
33 Gap PM9: Characterization of Material Extrusion Feedstock (Filaments & Pellets). There are many
34 classification systems and test procedures that are available and applicable to characterizing the
35 feedstocks used for filaments or pellets. However, these are based on “conventional” processes and
1 requirements and, in many cases, will need to be adapted to AM requirements and, in some cases, new,
2 more specific systems and procedures may be required.
3
4 Conventional rheometry is usually torsional while the behavior in AM systems is more accurately
5 represented by capillary rheometry. While a few standards exist for this, their scope is often limited.
6 ASTM D1238 for example only uses a 2.095 mm die while extrusion systems have a wide variety of
7 orifice diameters. Research will need to be done to determine the effect of this difference, as well as
8 other differences in the stress state like potential for back flow, and new standards should be developed
9 accordingly.
11 R&D Expectations: To define the specific requirements and evaluate if these can be addressed by
12 existing systems and procedures and, if not, to develop new ones.
13 Recommendation: Since this will be very dependent on specific materials and process requirements,
14 existing documents need to be evaluated on a case-by-case basis and, if necessary, new documents
15 need to be developed. This is another aspect that needs to be considered by a possible ASTM F42 and
16 D20 collaboration.
18 Organizations: ASTM F42/D20, SAE AMS-AM

21 Repair; ☐Data

24 Material Type: ☐All/Material Agnostic; ☐Metal; ☒Polymer; ☐Ceramic; ☒Composite
25 Process Category: ☐All/Process Agnostic; ☐Binder Jetting; ☐Directed Energy Deposition; ☒Material

29 Current Alternative: N/A
31 ☐New
1 V3 Update: Standards published or new projects started since v2 are noted in the text.
2 2.2.1.5.4 Moisture Content
3 The moisture content of the material extrusion feedstock must be characterized. Moisture within the
4 feedstock has a large effect on potential defects within the AM part.
6  ASTM D6980-17, Standard Test Method for Determination of Moisture in Plastics by Loss in
7 weight
8  ASTM D7191-18, Standard Test Method for Determination of Moisture in Plastics by Relative
9 Humidity Sensor
13
14 2.2.1.5.5 Thermal Stability
15 Since these processes involve exposure to elevated temperatures in their production and in the melting
16 or softening of the material in the AM process, the thermal stability is critical as excessive temperatures
17 or exposure times can result in degradation and changes in the composition and material properties.
19  ASTM D3012-19, Standard Test Method for Thermal-Oxidative Stability of Polypropylene Using a
20 Specimen Rotator Within an Oven
21  ASTM D3895-19, Standard Test Method for Oxidative-Induction Time of Polyolefins by
22 Differential Scanning Calorimetry
25
26 2.2.1.6 Characterization of Liquid Feedstock
27 Liquid feedstock is often produced by mixing a variety of monomers, oligomers, initiators, pigments,
28 stabilizers, etc. These materials are chemically reactive and need to be carefully characterized to ensure
29 the liquid feedstock has not begun to react and is still viable for use within the additive manufacturing
30 process.
31 2.2.1.6.1 Chemical Composition
32 Chemical characterization (including composition, molecular weight of oligomers, chemical structure,

33 and impurity content) is important to define the feedstock and therefore to determine the
1 characteristics of built parts. Specifications and standards are well established to determine molecular
2 weight, structure, end groups, and degree of conversion.
3 2.2.1.6.2 Viscosity
4 The viscosity of the liquid feedstock is extremely important to how well the material can be processed
5 through the specific AM technique (SLA or Material Jetting). It is often monitored throughout the
6 process to indicate the liquid precursor health. Large changes in the viscosity can indicate a change in
7 chemical composition (material be slowly polymerized, filler content increasing of stratifying) and can
8 affect how well the material is processed, the final AM part density and mechanical strength.
9 Characterization may require samples from various stages in the AM process.
10 Identified published standards not specific to AM include:
11  ASTM D1084-16(2021), Standard Test Methods for Viscosity of Adhesives

12  ASTM D4212-16, Standard Test Method for Viscosity by Dip-Type Viscosity Cups
13
14 2.2.1.6.3 Feedstock Sampling
15 Control of liquid feedstock is key to obtaining consistent and predictable properties of AM objects.
16 Metrics for assessing liquid material characteristics especially in an open system depend upon testing of
17 a representative sample. Considerations for liquid sampling include:
18  Methods of retrieval of a sample to ensure a random and representative sample is taken.

19  Quantity of liquid to be sampled, possibly as a function of total batch size.
20  Frequency at which to sample the liquid, including how long the liquid can be stored or in use
21 before necessitating repeat sampling.
22 Gap PM10: Sampling of Open Liquid Feedstock System. There is a need to develop a standard for
23 monitoring and sampling open liquid feedstock systems to ensure the consistent chemical composition
24 and mechanical properties in the final AM part.
26 R&D Expectations: R&D is needed to determine how much the viscosity can change before having a
27 significant effect on the mechanical and chemical properties of the final AM part, how fast the change
28 can happen and the frequency and method for sampling the open liquid feedstock system.
29 Recommendation: Develop a process-specific standard to indicate how often the liquid feedstock
30 viscosity must be monitored throughout the feedstock’s lifetime (both in storage and in an open
31 system).
33 Organization: ISO/ASTM, Industry OEMs
3 Repair; ☒Data

6 Material Type: ☐All/Material Agnostic; Metal; ☒Polymer; ☐Ceramic; ☒Composite

13 ☐New
14 V3 Update: None provided.
15 Other Precursor Materials Standards Activity Since Roadmap v2 - Relevance to Sections/Gaps

16 Not Yet Determined

18  SAE AMS7037, Steel, Corrosion and Heat-Resistant, Powder for Additive Manufacturing, 17Cr –
19 13Ni – 2.5Mo (316L), (2021-11-23)
20  SAE AIR7352, Additively Manufactured Component Substantiation (2019-10-31)

22  ASTM WK69730, Specification for Additive Manufacturing -- Wire for Directed Energy Deposition
23 (DED) Processes in Additive Manufacturing
24  ASTM WK74302, Specification for Additive Manufacturing for construction – process
25 characteristics and performance – specification for manufactured Polymeric Ultraviolet (UV)-
26 Cured Structures for Residential applications
27  ASTM WK78093, Guide for Additive Manufacturing -- Feedstock Materials -- Guide for Testing
28 Moisture Content in Powder Feedstock. This is AM CoE project 2010 being developed in F42.01.
29  ASTM WK83145, New Practice for Additive Manufacturing -- Feedstock Materials -- Assessing
30 the effect of moisture
31  SAE AMS7045, Aluminum Alloy Powder,5.3Zn – 3.3Mg - 1.7Zr – 1.6Cu (Composition similar to
32 7A77.50), (2022-01-14)
33  SAE AMS7103 - Material for High Performance Laser Sintering (2019-01-15)
1 2.2.2 Process Control
2 2.2.2.1 Introduction
3 For purposes of this document, process control refers to the control of variables that affect the quality
4 of parts fabricated via AM. These variables are encountered in every step of the AM process, including
5 creation and control of the 3D part model, selection and characterization of feedstock material,
6 operator training, selection of machine parameters used for the part build, calibration and maintenance
7 of equipment, and part post-processing. Control of such a wide range of variables is particularly
8 important in the AM industry because inspection techniques that are commonly used to verify part
9 quality can be challenging to apply to AM parts and must be taken into consideration when factoring in
10 the qualification of a given component. This section discusses various aspects of AM process control and
11 describes the standards that already exist or that are needed to ensure that acceptable AM parts can be
12 consistently fabricated. Operator training and qualification is addressed in the Qualification and
13 Certification section.
14 Published Standards and Specifications
15  API Standard 20S, Additively Manufactured Metallic Components for Use in the Petroleum and
16 Natural Gas Industries, First Edition (2021-10-01)
17  API Standard 20T Additively Manufactured Polymer-Based Components for Use in the
18 Petroleum and Natural Gas Industries, First Edition (2022-08-01)
19  ASTM F3091/F3091M-14, Standard Specification for Powder Bed Fusion of Plastic Materials
20  ASTM F3187-16, Standard Guide for Directed Energy Deposition of Metals
21  AWS D17.1/D17.1M:2010-AMD1, Specification for Fusion Welding for Aerospace Applications -
22 AMD
23  AWS D20.1/D20.1M:2019 Specification for Fabrication of Metal Components using Additive
24 Manufacturing
25  DIN 65124, Aerospace series - Technical specifications for additive manufacturing of metallic
26 materials with the powder bed process
27  DNV-ST-B203 Additive manufacturing of metallic parts Edition 2022-10
28  ISO/ASTM 52903-2:2020, Additive manufacturing — Material extrusion-based additive
29 manufacturing of plastic materials — Part 2: Process equipment (reviewed/confirmed in 2022)
30  ISO/ASTM 52904:2019, Additive manufacturing — Process characteristics and performance —
31 Practice for metal powder bed fusion process to meet critical applications
32  NCAMP NPS 89085 Rev D ULTEM 9085 April 18, 2021 (NCAMP Process Specification)
33  SAE AMS7003A, Laser Powder Bed Fusion Process (2022-08-05)
34  SAE AMS7005, Wire Fed Plasma Arc Directed Energy Deposition Additive Manufacturing Process
35 (2019-01-31)
36  SAE AMS7007, Electron Beam Powder Bed Fusion Process (2020-07-01)
37  SAE AMS7010A, Laser Directed Energy Deposition Additive Manufacturing Process (L-DED)
38 (2021-10-28)
1  SAE AMS7022, Binder Jet Additive Manufacturing (BJAM) Process (2020-11-19)
2  SAE AMS7027, Electron Beam Directed Energy Deposition-Wire Additive Manufacturing Process
3 (EB-DED-Wire) (2020-11-18)
4  SAE AMS7100, Fused Filament Fabrication, Process Specification for (2019-10-09)
5  VDI 3405-2 Blatt 2:2013, Additive manufacturing processes, Rapid Manufacturing, Beam Melting
6 of Metallic Parts, Qualification, Quality Assurance and Post Processing
7 Another published document is ASME PTB-13-2021: Criteria for Pressure Retaining Metallic Components
8 Using Additive Manufacturing (May 31, 2021). It was prepared by the ASME Board on Pressure
9 Technology Codes and Standards (BPTCS)/Board on Nuclear Codes and Standard (BNCS) Special
10 Committee on Use of Additive Manufacturing. The criteria provided in this Pressure Technology Book
11 (PTB) address the construction of pressure retaining components by means of the AM Powder Bed
12 Fusion process (PBF) using both Laser and Electron Beam energy sources. This is not a standard; rather it
13 is a criteria document meant to be used in conjunction with the construction codes that may wish to
14 address components constructed with additive manufacturing. The Special Committee is currently
15 discussing direct energy deposition, but it is too early to estimate if there will be a second document, or
16 a revision of this PTB.
17 Also, not a standard but relevant is the auditing checklist AC7110/14, Nadcap Audit Criteria for Laser and
18 Electron Beam Metallic Powder Bed Additive Manufacturing.
19 2.2.2.2 Digital Format and Digital System Control
20 Process control of digital format throughout CAD, CAM, and additive programming systems is critical to
21 maintain production quality. In the event of software revisions and upgrades, the complexity of the
22 systems requires the user to confirm that parts produced maintain the same level of quality: form, fit,
23 and function/material properties. Inexperienced operators may not be aware of automated or OEM
24 installed system upgrades and may assume status quo when restarting operations.
25
27  3D Manufacturing Format (3MF)

29 Manufacturing. Paragraph 7.2 requires that a contractor have a digital control plan in place and
30 defines the items that must be included in such a plan.
31  ISO/ASTM 52904:2019, Additive manufacturing – Process characteristics and performance –
33  ISO/ASTM 52915:2020, Specification for Additive Manufacturing File Format (AMF) Version 1.2.
34  ISO 14649-17:2020 Industrial automation systems and integration — Physical device control —
35 Data model for computerized numerical controllers — Part 17: Process data for additive
36 manufacturing
37  NCAMP NPS 89085 Rev D ULTEM 9085 April 18, 2021 (NCAMP Process Specification)
3 (2019-01-31)
6 (2021-10-28)
9 (EB-DED-Wire) (2020-11-18)
12  ISO/ASTM DIS 52904, Additive manufacturing of metals — Process characteristics and performance
13 — Metal powder bed fusion process to meet critical applications
14  ISO/AWI 10303-238 E4 Industrial automation systems and integration — Product data
15 representation and exchange — Part 238: Application protocol: Model based integrated
16 manufacturing
17 Gap PC1: Digital Format and Digital System Control. Existing process control standards do not
18 adequately address digital format and digital system control.
20 R&D Expectations: NIST is putting R&D into the ISO 10303 AP 238 E4 that aims to support (to an extent)
21 process control for PBF AM processes.
22 Recommendation: Leverage ongoing NIST research and work with SDOs to ensure that AM process
23 control standards include digital format and digital system control.
25 Organization: NIST, ISO/ASTM JG 56, ISO TC 184 SC4, SAE, IEEE-ISTO PWG, AWS
26 Lifecycle Area: ☐Design; ☐Precursor Materials; ☒Process Control; ☐Post-processing; ☐Finished

28 Repair; ☒Data


7 ☐New
9 2.2.2.3 Machine Calibration and Preventative Maintenance
10 Machine calibration and preventative maintenance can impact output quality and require periodic
11 measurement in addition to any OEM maintenance. Users must confirm that an AM machine continues
12 to generate products which meet all quality requirements after maintenance is performed. For example,
13 the requalification process can range between a full first article to a subset thereof and may include
14 metallographic analysis.
15 Additionally, routine maintenance and performance checks of machine components vary between OEMs
16 and are often not open to the end user. Standard tests of machine components, however, can allow end
17 users to regularly assess machine performance. This will create confidence that a machine is functioning
18 as expected and allow the end user to alert the OEM of required maintenance prior to build failures.
19 Research is required to determine how, and at what magnitude, errors in machine components affect
20 output quality so that machine calibration and preventative maintenance checks with appropriate
21 tolerances can be developed.
22 For example, in the case of laser-based powder bed fusion, the motion control components are trusted
23 to provide accurate positioning. Scanner calibration, which measures galvanometer-driven mirror
24 performance, is currently performed at installation of the machine by the OEM, but not all OEMs
25 perform this test and calibration at the time of maintenance. Errors in the scanner system can lead to
26 reductions in build quality and, at a minimum scanner calibration should be performed annually. The
27 OEMs currently will not allow users to calibrate the scanner, but a standardized test could quantify any
28 changes and flag when a calibration would be needed. In addition to the scanner calibration, “fine
29 tuning” may address this requirement. Fine tuning is a quick build that is run to check many different
30 inputs from process parameters. After measuring the “fine tuning” build, adjustments could be made or
31 the OEM could be alerted of required adjustments to improve the quality of the builds that follow.
32 As another example, in ink-based powder bed fusion, part accuracy and powder health depend on lamp
33 irradiance and ink-deposition accuracy. Irradiance is calibrated at installation. Ink-deposition is also
34 calibrated at installation. Actual ink deposition is monitored during part manufacturing to determine if
35 the print will continue as expected. In addition to process calibration and monitoring, part quality can be
1 monitored using current quality and process control (QPC) methods. Standardized methods could be
2 developed to enable a better QPC method specific to additive manufacturing, which can often include
3 high-mix, low-volume applications. In addition, for low-mix, high-volume applications, the QPC standard
4 may be extended to take advantage of the flexibility of additive manufacturing.
5 This issue is closely linked to digital format and digital system control, and machine qualification. See
6 also section 2.5.2 on maintenance and sustainment of machines.

9 Manufacturing
12  ISO/ASTM 52910:2018, Additive manufacturing — Design — Requirements, guidelines and
13 recommendations
14  ISO/ASTM 52941:2020, Additive manufacturing — System performance and reliability —
15 Acceptance tests for laser metal powder-bed fusion machines for metallic materials for aerospace
16 application
18 SAE AMS7032, Machine Qualification for Fusion-Based Metal Additive Manufacturing (2022-08-
19 17)
21  SAE AMS7100/1, Fused Filament Fabrication Process - Stratasys Fortus 900mc Plus with Type 1,
22 Class 1, Form 1, Grade 0 Natural Color Material for (2022-07-06)
23
25  ASTM WK65929, New Specification for Additive Manufacturing-Finished Part Properties and
26 Post Processing - Additively Manufactured Spaceflight Hardware by Laser Beam Powder Bed
27 Fusion in Metals
29 Hardware made by Laser Beam Powder Bed Fusion Process
32  ASTM WK78092, New Practice for Additive Manufacturing -- Powder Bed Fusion -- Condition-
33 defined Maintenance for Optical Systems
34  ISO/TC 261/JG 52, Joint ISO/TC 261-ASTM F 42 Group: Standard test artifacts
35  ISO/ASTM DIS 52904, Additive manufacturing of metals — Process characteristics and performance
36 — Metal powder bed fusion process to meet critical applications
37  ISO/ASTM DIS 52945, Additive manufacturing for automotive — Qualification principles —
38 Generic machine evaluation and specification of key performance indicators for PBF-LB/M
39 processes
1  SAE AMS7100/2 - Fused Filament Fabrication – Markforged X7 with Onyx FR-A Type, Class,
2 Grade, Black (2021-10-21)
3  SAE AMS7104, Continuous Fiber Reinforced Fused Filament Fabrication (2021-10-21)
4  SAE AMS7104/1, Continuous Fiber Reinforced Fused Filament Fabrication Markforged (2021-10-
5 21)
6  SAE ARP7064, Machine Requalification Considerations for Fusion-Based Metal Additive
7 Manufacturing (2022-07-22)
8
9 Gap PC2: Machine Calibration and Preventative Maintenance. Standards are needed to explain how to
10 address machine calibration and preventative maintenance for additive manufacturing in a way that
11 does not inhibit innovation. A challenge is that there may be different process variables by machine and
12 so machine OEM recommended practices are relied upon. Current users may not have established best
13 practices or their own internal standards and often assume that the machine OEM maintenance
14 procedures are sufficient to start/restart production. Additionally, AM machines have many mechanical
15 components that are similar to conventional subtractive machinery. The motion control components are
16 trusted to provide accurate positioning and it is currently unknown how errors in these systems affect
17 the output quality. This is important during machine qualification and could be addressed in a standard.
19 R&D Expectations: Research is required to determine how errors in machine components affect output
20 quality so that tolerances can be developed for machine calibration and preventative maintenance
21 checks
22 Recommendation: Complete work on standards in development (e.g., ISO/ASTM 52945) addressing

23 machine calibration and preventative maintenance. In addition, machine OEM and end user best
24 practices should ensure adequate and recommended calibration and maintenance intervals that have
25 been documented with data from different materials and process control documents (PCDs). Machine
26 OEMs and SDOs should develop technical reports that incorporate case studies related to machine
27 restart after maintenance.
28 Priority: ☒High; ☐Medium; ☐Low / There is an urgent need to develop guidelines on day-to-day
29 machine calibration checks.
30 Organization: AWS D20, ASTM F42/ISO TC 261, SAE AMS-AM, NIST, OEMs, end users, experts in
31 machine metrology

33 Material Properties; ☐Qualification & Certification; ☐Nondestructive Evaluation; ☒Maintenance and
34 Repair; ☐Data


8 ☐New
10
11 Gap PC3: Machine Health Monitoring. Standards are needed to address AM machine health monitoring.
12 Machine health monitoring is a process of observing the machinery to identify changes that may
13 indicate a fault. The use of a machine health monitoring system allows maintenance to be scheduled in a
14 timely manner so as to prevent system failure.
16 R&D Expectations: ASTM AM CoE Strategic Roadmap for Research & Development (April 2020) notes
17 that AM CoE Project 1901 (WK71395) under F42.01 addresses AMSC gap PC3.
18
19 Recommendation: Adapt existing health monitoring (diagnostics and prognosis) standards for use in the
20 additive manufacturing industry. Examples of such standards are the semiconductor industry “Interface
21 A” collection of standards and ISO 13379-1:2012, Condition monitoring and diagnostics of machines -
22 Data interpretation and diagnostics techniques - Part 1: General guidelines and ISO 13381-1:2015,
23 Condition monitoring and diagnostics of machines - Prognostics - Part 1: General guidelines. Additional
24 information can be found in NISTIR 8012, Standards Related to Prognostics and Health Management
25 (PHM) for Manufacturing. Further research/guidelines/specifications may be needed. For example, NIST
26 may be able to identify critical indicators that need to be documented or controlled to assist end users
27 with quality assurance. See also gap M6 on Tracking Maintenance.
29 Organization: NIST, ISO, ASTM, AWS, IEEE-ISTO PWG, ASME

32 Repair; ☐Data

10 ☐New
11 V3 Update: ASME has a non AM-specific project concerning Advanced Monitoring, Diagnostics, and
12 Prognostics for Manufacturing Operations which is being conducted by the ASME Prognostics and
13 Health Management (PHM) Subcommittee. Current efforts are focused on the development of a
14 guideline that manufacturers can use to identify opportunities and implement advanced monitoring,
15 diagnostic, and prognostic technologies within their facilities. The guideline is being written in an
16 agnostic manner such that it could be applied to operations involving subtractive machine tools,
17 robotics, or additive processes. The draft guideline will cover: baseline metrics and identification of pain
18 points, PHM readiness characterization, where to deploy and improve existing PHM deployments, and
19 the determination of a PHM business case for manufacturing systems. The PHM guideline is targeted to
20 be published in 2023.
21 2.2.2.4 Machine Qualification
22 To ensure repeatability in AM builds, it is necessary to ensure that the machine is qualified. Machine
23 qualification encompasses installation (IQ), operation (OQ), and performance (PQ). From a pure machine
24 qualification standpoint, it is OQ. PQ comes into play in ensuring that the machine is building the part
25 you want.
27 Some of these documents may only cover aspects of IQ, OQ, PQ):
28  API Standard 20S, Additively Manufactured Metallic Components for Use in the Petroleum and
29 Natural Gas Industries, First Edition (2021-10-01)
30  API Standard 20T Additively Manufactured Polymer-Based Components for Use in the
31 Petroleum and Natural Gas Industries, First Edition (2022-08-01)
32  ASTM F3301-18, Standard for Additive Manufacturing – Post Processing Methods – Standard
33 Specification for Thermal Post-Processing Metal Parts Made Via Powder Bed Fusion
2 Manufacturing
3  DNV-ST-B203 Additive manufacturing of metallic parts Edition 2022-10
4  SAE AMS7003, Laser Powder Bed Fusion Process
5  SAE AMS7032, Machine Qualification for Fusion-Based Metal Additive Manufacturing
6  SAE AMS7100, Fused Filament Fabrication, Process Specification for
7  ISO/ASTM 52903-2:2020, Additive manufacturing — Material extrusion-based additive
8 manufacturing of plastic materials — Part 2: Process equipment (reviewed/confirmed in 2022)
11  ISO/ASTM 52930:2021, Additive manufacturing — Qualification principles — Installation,
12 operation and performance (IQ/OQ/PQ) of PBF-LB equipment
16  NASA-STD-6030, Additive Manufacturing Requirements for Spaceflight Systems
17  NASA-STD-6033, Additive Manufacturing Requirements for Equipment and Facility Control
18  NAVSEA S9074-A2-GIB-010/AM-PBF - Requirements For Metal Powder Bed Fusion Additive
19 Manufacturing
20  NAVSEA S9074-A4-GIB-010/AM-WIRE DED - Requirements For Metal Directed Energy Deposition
22
24  ASTM WK71395, New Practice for Additive manufacturing -- accelerated quality inspection of
26  ASTM WK72659, New Guide for Guideline for Material Process Validation for Additive
27 Manufacturing of Medical Devices
28  ASTM WK73231, Additive manufacturing -- System performance and reliability -- Acceptance
29 tests for laser metal powder-bed fusion machines for metallic materials for aerospace
30 application
31  ASTM WK73688, New Specification for Additive manufacturing -- Qualification principles --
32 Generic machine evaluation and KPI Definition for LPBF-M Processes in Automotive Applications
33  AWS is developing D20.2 for wire processes. D20.1 is being revised to only cover metal powder
34 processes (PBF, blown powder DED).
35  ISO/ASTM CD 52904, Additive manufacturing of metals — Process characteristics and
36 performance — Metal powder bed fusion process to meet critical applications (revision of 2019
37 version)
38  ISO/ASTM DIS 52945, Additive manufacturing for automotive — Qualification principles —
39 Generic machine evaluation and specification of key performance indicators for PBF-LB/M
40 processes
1  SAE ARP7064, Machine Requalification Considerations for Fusion-Based Metal Additive
2 Manufacturing (2022-07-22)
3
4 Gap PC4: Machine Qualification. There have been advances in developing standards related to machine
5 qualification (e.g., SAE AMS7032 and ISO/ASTM 52930), largely focused on powder bed fusion and
6 metals. Additional standards may be needed to address machine qualification for different AM
7 processes, materials, and applications.
9 R&D Expectations: In relation to test artifacts, evaluating process monitoring against NDE. More
10 developed machine performance characterization tests (e.g., through test artifacts that enable machine-
11 to-machine comparison of performance, and day-to-day performance of the same machine).
12 Recommendation: Develop standards for machine qualification for different AM applications, processes,
13 and materials (primarily polymers and ceramics) where they do not currently exist.
15 Organization: NIST, AWS, SAE AMS-AM, ASTM F42, NAVSEA, NASA

18 Repair; ☐Data


28 ☐New
1 2.2.2.5 Parameter Control
2 Parameter control is integrally linked to software, maintenance, and machine qualification protocols.
3 Parameters are typically controlled through software but also require that calibrations be within
4 periodic measurement to ensure part quality.
5 Variability within and among AM parts has been widely reported in the AM industry. Variability has been
6 noted among parts with different inter-layer (i.e., interpass) times, along the z-direction within a single
7 part, within a part that contains features of varying thickness, among parts built in different locations on
8 the same build platform, among parts built with different surroundings on the build platform, between
9 as-built and machined parts, between parts built with different AM machines of the same model, etc.
10 Most material property variability within and among AM parts is the result of varying thermal histories
11 and their effect on local material microstructures and defect formation. Recognition of these build
12 anomalies also has been widely mitigated in industry best practices.
13 As has been widely noted in the AM industry, there are a vast number of process parameters that are
14 either programmed by the operator via AM machine software or are controlled by the AM machine
15 without operator input. In some instances, AM machines are manufactured such that the buyer cannot
16 know or control all of the process parameters. This is an intellectual property (IP) issue that is a barrier
17 to the full understanding of the effects of process parameters on AM part performance. Additionally,
18 many AM part producers treat process parameters that they have developed as IP in order to maintain a
19 competitive advantage in the AM industry.
20 Most material specifications identify the need to have parameter control. Those listed below are limited
21 to those that discuss how to specifically control process parameters.

24 Manufacturing
31
33
34  ISO/ASTM CD 52904, Additive manufacturing of metals — Process characteristics and
35 performance — Metal powder bed fusion process to meet critical applications (revision of 2019
36 version)
37
1 Gap PC5: Parameter Control. As a result of the many sources of variability within and among AM parts,
2 and because a complete understanding of the specific effects of so many build process parameters on
3 AM part performance is not currently available in the AM industry, standards are needed to identify
4 requirements for demonstrating that a set of build process parameters produces an acceptable part,
5 and for ensuring that those build process parameters remain consistent from build to build.
8 that AM CoE Projects 1804/1907 (WK65937, WK65929) address AMSC gap PC5. Develop and establish a
9 set of verifiable, accurate, and unambiguous process parameters for different materials and processes
10 where this is not already available.
11 Recommendation: Develop a standard(s) that identifies what key build process parameters need to be
12 controlled for AM, taking into account the different processes, materials, industry-specific applications,
13 and machines involved. Parameter control may require detailed standards describing calibration or
14 elements of the equipment such as gas flow, meter, position indicator accuracy, etc. Such a standard(s)
15 would not necessarily describe how to control the parameters due to intellectual property
16 considerations. Some documents already exist, e.g., AWS D20.1, that address process parameters for
17 PBF and DED. It is important to develop standards addressing parameter controls for polymer AM (nylon
18 powder bed fusion, material extrusion, binder jetting, vat photopolymerization). See also gap QC3 on
19 harmonizing Q&C terminology for process parameters.
21 Organization: AWS D20, ISO/TC 261-ASTM F42, SAE AMS-AM, IEEE-ISTO PWG

24 Repair; ☐Data


2 ☐New
4 2.2.2.6 Adverse Machine Environmental Conditions: Effect on Component Quality
5 AM machines may be used in environments where they are subject to vibration, minor seismic activity,
6 roll and pitch (e.g., shipboard), or gradients in temperature, pressure, humidity, dew point, etc. AM
7 machines need to be qualified not only for the manufacture of a set population of parts, but also to
8 operate in the requisite environment. For example, a machine could reside in a plant where other
9 machines are constantly in operation or heavy trucks drive past. The vibrations that could carry through
10 structures and/or the floor/ground need to be sufficiently mitigated during manufacturing. Otherwise,
11 the machine should only be used when those types of adverse factors are not present. The final product
12 must not be adversely impacted due to environmental conditions.
13 For the defense industry, the forwardly deployed environment (e.g., in theatre or shipboard) has unique
14 impacts on AM processes that are not fully understood at this point. Usage of AM machines in these
15 environments needs to be performed by or under the guidance of qualified AM operators, using
16 qualified machines.

20 (2019-01-31)
23 (2021-10-28)
26 (EB-DED-Wire) (2020-11-18)
29
31  SAE AMS7029, Cold Metal Transfer Directed Energy Deposition (CMT-DED) Process (2020-02-03)
32  SAE AMS7034 - Hybrid Laser Arc Directed Energy Deposition (HLA-DED) (2020-08-31)
33
1 Gap PC6: Adverse Machine Environmental Conditions: Effect on Component Quality. There is a need
2 for more research as well as standards or specifications that address AM machines being able to work in
3 adverse environmental conditions.
5 R&D Expectations: An investigation needs to be conducted to assess the effect and significance of all
6 expected environmental conditions on AM processes. This would likely be limited to one technology but
7 could include several different machines. Such investigation might need to be multivariate- in nature.
8 Recommendation: Develop standards and specifications to address external environmental factors that
9 could negatively impact component quality.
11 Organization: OEMs, DoD for military-specific operational environments, ASTM

14 Repair; ☐Data
15 Sectors: All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☒Defense; ☐Electronics;

20 Q&C Category: ☒Materials; ☒Processes/Procedures; ☒Machines/Equipment; ☒Parts/Devices;

22 Current Alternative: None Specified.
24 ☐New
25 V3 Update: Published standards and standards in development are noted in the text.
26 2.2.2.7 Stratification
27 Metal powders used in additive manufacturing are composed of a distribution of attributes (e.g., particle
28 size, morphology, moisture, chemistry, etc.) which can be unique based on supplier and process.
29 Stratification involves generation of non-homogenized powder lots that may occur with the use of
1 powder during batch or closed loop equipment. Users must be aware of the existence of stratification
2 and its potential impact on traceability to precursor materials used to produce parts. Powder
3 specifications and their associated requirements may still apply but how that applies to stratification is
4 application specific.
10
13 cycle management
16
17 Gap PC8: Stratification.11 There is currently a lack of guidance regarding stratification in virgin and
18 reused metal powder scenarios.
20 R&D Expectations: Research should be conducted to understand the effect of stratification on particle
21 size distribution and other metal powder attributes of as-received powder and mixed/blended powder
22 prior to being put into service.
23 Recommendation: Develop guidelines on how to maintain traceability of metal powder feedstocks or

24 create new lots of powder feedstock across stratification boundaries or gradients throughout the build
25 cycle(s) impacted.
27 Organization: ISO/ASTM, SAE

30 Repair; ☐Data
11
Gap PC8 was substantially overhauled from what appeared in roadmap v2, retaining only the same number and
topic. Issues of powder use and reuse are generally discussed in the precursor materials section of this roadmap.
5 Extrusion; ☒Material Jetting; ☒Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photopolymerization

10 ☐New
11 V3 Update: Published and in-development standards are noted in the text
12 2.2.2.8 Powder Blending and Powder Mixing Terminology
13 During discussion of stratification, it was noted that there are differences in terminology on powder
14 blending and powder mixing in relevant industry documents from ISO/ASTM and SAE. Definitions are
15 noted below.
16 From ISO/ASTM 52900:2021, Additive manufacturing — General principles — Fundamentals and

17 vocabulary, section 3.8, Processing: powder bed fusion:
18 3.8.6
19 powder blend, noun
20 quantity of powder made by thoroughly intermingling powders originating from one or several
21 powder lots (3.6.2) of the same nominal composition
22 Note 1 to entry: A common type of powder blend consists of a combination of virgin (3.6.4)
23 powder and used powder (3.8.9). The specific requirements for a powder blend are typically
24 determined by the application or by agreement between the supplier and end-user.
25 Note 2 to entry: A distinction is made between blended powders and mixed powders, in which
26 case blended powders are combinations of powders with nominally identical composition,
27 whereas mixed powders are combinations of powders with different compositions.
28 3.8.7
29 powder mix, noun
30 powder mixture
31 quantity of powder made by thoroughly intermingling powders of different nominal composition
1 Note 1 to entry: A distinction is made between blended powders and mixed powders, in which
2 case blended powders are combinations of powders with nominally identical composition,
3 whereas mixed powders are combinations of powders with different compositions.
4
5 From SAE AMS7031, Batch Processing Requirements for the Reuse of Used Powder in Additive
6 Manufacturing of Aerospace Parts, section 8.2.1, Definitions:
7
8 POWDER BLENDING: The process of combining powder of the same nominal size, chemistry, and
9 physical attributes in such a way that the characteristics of the powder are uniform throughout.
10 The powder to be blended may be from a single machine or multiple machines, originating from
11 a single or set of nominally similar lots of feedstock and with similar process history. Powder
12 blending is limited to powder lots, in-process and/or virgin, where each constituent is
13 conforming to the same specification for all compositional and morphological requirements. See
14 4.5 for implementation.
15
16 POWDER MIXING: The process of combining two or more different batches of powder with
17 distinctly different chemical compositions, original particle size ranges, AM process histories, or
18 other physical characteristics in such a way that makes the resultant mixture homogenous and
19 uniform throughout. Powder mixing describes the combining of lots of powder, in-process
20 and/or virgin, where each constituent is described by powder specifications with different
21 (uncommon; not shared/overlapping) compositional and morphological requirements. (Note:
22 Powder mixing is not allowed in this specification as inhomogeneities, potentially detrimental to
23 properties, may not be detectable through bulk testing alone. The controlled process history
24 requirements of powder blending are intended to improve consistency)
25 New Gap PC18: Powder Blending and Powder Mixing Terminology. Differences exist in definitions of
26 powder blending/mixing in industry standards such as ISO/ASTM 52900:2021 and SAE AMS7031:2022.
29 Recommendation: Develop a technical report (TR) to clarify for the industry the terminology differences
30 in industry standards on powder blending and powder mixing.
32 Organization(s): ISO/ASTM, SAE

35 Repair; ☐Data


7 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☐Closed; ☒
8 New
9 2.2.2.9 Precursor Material Flow Monitoring
10 Directed Energy Deposition (powder)

11
12 For a DED process, it is critical to have some method to monitor powder flow during the build process as
13 it will have an influence on melt pool dynamics as well as geometry of the part.
14 ASTM F3187-16, Standard Guide for Directed Energy Deposition of Metals relates to this topic. No
15 standards in development have been identified.
16 Gap PC12: Precursor Material Flow Monitoring. There is no known standard for defining:
17  Method of DED process powder flow monitoring

18  Location of monitoring
19  Accuracy of flow monitoring
20  Standardized calibration process of flow
21
24 Recommendation: Develop a standard for DED process powder flow monitoring so that operators/users
25 will have a way to ensure the powder flow is coming out consistently and with minimal fluctuations so
26 as to not alter the desired build and its properties. See also gap PM1 on flowability.
28 Organization: NIST, ISO/ASTM
3 Repair; ☐Data

7 Process Category: ☐All/Process Agnostic; ☐Binder Jetting; ☒Directed Energy Deposition; ☐Material

11 Current Alternative: None Specified.
13 ☐New
15 Inkjet (Material Jetting)
16 Monitoring and control of all flow-related parameters for material jetting are critical to maintain the
17 high quality of the parts as well as the reliability of the printer.
18 Gap PC13: Flow Parameters for Material Jetting. No published standards or standards in development
19 have been identified for monitoring and control of all flow related parameters for material jetting.
22 Recommendation: Develop a standard for monitoring and controlling all flow parameters for material
23 jetting such as flow rate, temperature, viscosity, pressure level, wetting of the orifice plate, etc. This
24 standard should include:
25  Monitoring and controlling similar flow in different material feeding channels. This is needed to
26 allow multi-material printing while minimizing cross talk or non-uniformity between channels
27 keeping quality of all printed materials.
28  Controlling the thickness of the printed layer. In material jetting, the material flows to the surface
29 and controlling the thickness of each layer is clearly critical to maintain quality. The layer thickness
1 can be controlled by controlling the material flow within the system and within the printing heads as
2 well as by direct measurement after deposition.
3  Expanding the performance envelope to enable more degrees of freedom for the flow of material.
4 For example, to enable a wider range of temperatures, humidity control, oxygen level control, ink
5 recirculation in the print heads, etc. All this can allow using more viscous materials, with larger filler
6 particles and exotic materials that might not be compatible with the print head materials in a
7 standard environment.
8
10 Organization: NIST, OEMs, ASTM, IEEE-ISTO PWG

13 Repair; ☐Data

18 Extrusion; ☒Material Jetting; ☐Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photopolymerization

23 ☐New
25 2.2.2.10 Environmental Health and Safety: Protection of Machine Operators
26 Environmental health and safety (EHS) is a key aspect of AM process control. It includes protection of
27 the operators from materials (hazardous and non-hazardous), protection of the materials from operator
28 contamination, disposal of materials, and general operator health and safety in machine operation. The
29 potentially significant weight of the materials, and accessory equipment to move materials, is also a
30 consideration.
1 Typical hazards to be addressed when operating AM systems include: guarding from moving parts that
2 are not protected from contact; guarding from thermal injury; chemical handling (liquids, powders,
3 wires); housekeeping (surface contamination); air emissions (dusts, vapors, fumes); noise (cleaning
4 apparatus); electrical (water wash systems, electro-static systems); flammable/combustible cleaning
5 materials; solid waste; laser use (sintering processes); and UV light (may require eye and skin protection
6 based on design).
7 There are general OSHA standards for machine guarding,12 and for hand protection13 but more specific
8 standards are needed for AM processes. OSHA 1910.95 addresses noise exposure. OSHA, NIOSH, ASTM
9 and other standard air sampling and analysis methods for gases and dusts exist, and new standards for
10 AM are not needed for these analyses. Areas where standards are lacking that are important for AM
11 include particle-number based exposures to ultrafine particles and skin exposure to chemicals.
12 Research on indoor air quality, health, and human effects is underway between Underwriters
13 Laboratories, Inc. (UL), Georgia Tech, and Emory University. The National Institute for Occupational
14 Safety and Health (NIOSH) has laboratory- and workplace-based research programs that focus on
15 understanding emissions from AM machines, levels of emissions in workplace atmospheres, engineering
16 controls to reduce or eliminate emissions from AM machines, and toxicology studies to understand the
17 impact of exposures. NIOSH has freely available information resources on their website for protection of
18 machine operators engaged in various types of AM processes. Other Government agencies involved in
19 EHS research related to AM processes include the Environmental Protection Agency (EPA). OSHA and
20 EPA guidance with respect to handling of powders applies, and it is necessary to have proper chemical
21 hygiene in facilities where machine operations are taking place.
22 General industry standards related to industrial hazards include:
23  ANSI/ASSP Z9 series of standards that address industrial ventilation by scope and are specifically
24 written to address dusts, vapors, and fumes
25  ANSI/ASSP Z10.0-2019, Occupational Health and Safety Management Systems
26  ANSI/ASSP Z244.1-2016 (R2020), The Control of Hazardous Energy Lockout, Tagout and
27 Alternative Methods, that addresses the issue of moving parts and accidental release of energy
12
1910.212(a)(1) Types of guarding. One or more methods of machine guarding shall be provided to protect the
operator and other employees in the machine area from hazards such as those created by point of operation,
ingoing nip points, rotating parts, flying chips and sparks. Examples of guarding methods are - barrier guards, two-
hand tripping devices, electronic safety devices, etc.
13
1910.138(a) General requirements. Employers shall select and require employees to use appropriate hand
protection when employees' hands are exposed to hazards such as those from skin absorption of harmful
substances; severe cuts or lacerations; severe abrasions; punctures; chemical burns; thermal burns; and harmful
temperature extremes.
1  ANSI/ASSP Z590.3:2021, Prevention Through Design Guidelines For Addressing Occupational
2 Hazards And Risks In Design And Redesign Processes
3  ANSI/ASSP/ISO Standards for risk management and risk assessment (see below)
4 o ANSI/ASSP/ISO 31000-2018 Risk Management - Guidelines (digital only)
5 o ASSP/ISO TR-31000-2022 Risk Management – A Practical Guide (digital only)
6 o ANSI/ASSP/ISO/IEC 31010-2019 Risk Management - Risk Assessment Techniques (digital
7 only)
8 o ASSP TR-31010-2020 Technical Report: Risk Management - Techniques for Safety
9 Practitioners (digital only)
10 o ANSI/ASSP/ISO 31073-2022 Risk Management - Vocabulary (digital only)
11  ANSI B11 series of standards for machine tools safety
12  ANSI Z136 series of standards for laser safety
13  ISO 11553-1:2020, Safety of machinery - Laser processing machines - Part 1: Laser safety
14 requirements
15  ISO 45001:2018, Occupational Health And Safety Management Systems - Requirements With
16 Guidance For Use
17  See section 2.2.1.2 of this roadmap for additional health and safety considerations related to
18 storage, handling, and transportation.
19
21
22  UL 3400 Ed.1-2017, Outline of Investigation for Additive Manufacturing Facility Safety
23 Management, for the evaluation and certification of any additive manufacturing facility that
24 uses powder feedstock to print parts.
25
27
28 ASTM WK73227, New Guide for Additive Manufacturing (AM) – Investigation for Additive Manufacturing
29 (AM) – Facility Safety Management. ASTM and UL have signed an MOU to transpose UL 3400 to an
30 ASTM format and this work item is nearing completion.
31 ISO/TC 261 has a Working Group on Environment, health and safety (ISO/TC 261/WG 6), and three Joint
32 Groups with ASTM F42 on AM: EH&S for 3D printers (JG68), EH&S for use of metallic materials (JG69),
33 and harmonization of safety requirements for PBF-LB machines using metallic feedstock (JB78).
34  ISO/ASTM FDIS 52931, Additive manufacturing of metals – Environment, health and safety –
35 General principles for use of metallic materials (aka ASTM WK72391). This document is based on
36 a French national standard XP E67-006 Additive manufacturing - Safety, health and
37 environment - Requirements relating to metallic materials.
38  ISO/ASTM AWI 52938-1, Additive manufacturing of metals – Environment, health and safety –
39 Part 1: Safety requirements for PBF-LB machines (aka ASTM WK74933)
1
2 Gap PC14: Environmental Health and Safety: Protection of Machine Operators. There is a need for
3 standards to address environmental health and safety (EHS) in the AM process.
6 Recommendation: Develop standards addressing EHS issues relative to additive manufacturing

7 machines and processes.
9 Organization: ASTM F42/ISO TC 261, UL, ASSP, B11, LIA (Z136), ISO/TC 262

12 Repair; ☐Data


20 Current Alternative: General industry standards
22 ☐New
23 V3 Update: As noted in the text
24 2.2.2.11 Configuration Management
25 Configuration management includes software version control for the digital file and additive system (i.e.,
26 machines/equipment) controls.
27 Cybersecurity issues that arise with respect to AM process control include loss of intellectual property,
28 risk of unqualified aftermarket components, unauthorized modification of build files, and attacks on
29 machine software impacting part quality. Documented cases of malware intrusion in the software of
1 OEM machines have been shown to impact product quality and in some cases destruction of
2 manufacturing equipment. Intellectual property theft through counterfeiting is a growing international
3 concern, with the ease of copying AM process files only increasing this risk. Any modification to the
4 aftermarket components or build file can have significant impact to the part integrity and quality.
5 Published Standards and Guidance
6  ABS Volume 1, Guidance Notes on the Application of Cybersecurity Principles to Marine and
7 Offshore Operations
8  ABS Volume 2, Guide for Cybersecurity Implementation for the Marine and Offshore Industries
9  ABS Volume 3, Guidance Notes on Data Integrity for Marine and Offshore Operations
10  ABS Volume 4, Guide for Software Systems Verification
11  ABS Volume 5, Guidance Notes on Software Provider Conformity Program
12  IEEE-ISTO PWG 5199.10-2019: IPP Authentication Methods v1.0
13  IETF Internet Printing Protocol (IPP) over HTTPS Transport Binding and the 'ipps' URI Scheme –
14 RFC 7472
15  NIST Special Publication 800-82 Revision 2, Guide to Industrial Control Systems (ICS) Security
16  NIST Cybersecurity for Smart Manufacturing Systems project
17  ANSI/CAN/UL (UL 2900-1), Standard for Software Cybersecurity for Network-Connectable
18 Products, Part 1: General Requirements
19  UL 2900-2-1, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular
20 Requirements for Network Connectable Components of Healthcare and Wellness Systems
21  UL 2900-2-2 Ed. 1-2016, Outline of Investigation for Software Cybersecurity for Network-
22 Connectable Products, Part 2-2: Particular Requirements for Industrial Control Systems
23  ANSI/CAN/UL (UL 2900-2-3), Standard for Software Cybersecurity for Network-Connectable
24 Products, Part 2-3: Particular Requirements for Security and Life Safety Signaling Systems
25
27  ASTM WK78322, New Guide for Additive Manufacturing -- General Principles -- Guidelines for
28 AM Security
29  IEEE-ISTO PWG, IPP Encrypted Jobs and Documents v1.0
30  ISO/TC 261-ASTM F 42 Joint Group JG73: Digital product definition and data management
31
32 Gap PC15: Configuration Management. Best practices for maintaining and controlling the programming
33 environment for additive processes are needed to ensure repeatable product quality.
36 Recommendation: Develop best practices to protect digital files and equipment used in the AM process.
2 Organization: ISO/ASTM JG73, America Makes, NIST, UL, IEEE-ISTO PWG

5 Repair; ☐Data


15 ☐New
16 V3 Update: There are a number of published and in development standards as noted in the text.
17 2.2.2.12 In-Process Monitoring
18 In-process monitoring here refers to measurement systems applied during the fabrication process, and
19 includes measurements of the part(s) being built, process signatures such as melt pool emissions, as well
20 as AM machine conditions such as oxygen, chamber temperature, etc. Machine condition monitoring is
21 relatively high technology readiness level (TRL). In-process monitoring directed at the part fabrication
22 (e.g., melt pool monitoring) is generally at a lower TRL compared to more established NDE methods
23 used to inspect parts after build (see gap NDE3). While systems are emerging and much research is
24 being conducted, an analysis of in-process monitoring data will need to take into account the process
25 engineer’s level of knowledge, maturity of the monitoring method, the process design complexity of the
26 build, the requisite rigor needed for in-process monitoring of the component being manufactured, and
27 the ability to incorporate the necessary sensor-based technologies into a given process without
28 interfering with the build.
29 When feedstock supply, process conditions, or process parameters are monitored during a build, the
30 goal is to have machines that are self-monitoring and self-calibrating, and can self-correct and control
31 important equipment performance parameters during the build.
2  ASTM E3353-22, Standard Guide for In-Process Monitoring Using Optical and Thermal Methods
3 for Laser Powder Bed Fusion (previously WK73289 and WK62181)) published by ASTM E7.10
4
5 ASTM E3353-22 does not cover conversion of monitoring data to a 3D file (e.g., data alignment/
6 registration, which is anticipated to be covered by ASTM WK74390). It does cover commercial melt pool
7 monitoring and layer-wise imaging systems, as well as some aspects of machine health monitoring and
8 statistical process control. It does not provide specific details or methodology for linking indications to
9 defects, but provides general guidelines based on the current state of art at time of publication.
10 The guide E3353-22 covers the general methods by which commercial in-process monitoring systems
11 may be applied (e.g., process development vs. product development), overview of some important
12 related concepts (e.g., data alignment or registration, statistical process control, and machine learning).
13 The guideline provides sections on specific technology categories with more details, including melt pool
14 monitoring, layer-wise imaging, and machine condition monitoring technologies. Details for each
15 technology category include general operating principles, instrument design considerations, potential
16 observable flaws, and other pertinent aspects. It is anticipated that additional process monitoring or in-
17 process NDE technologies will be added to future versions of the standard.
19 of Data Pedigree. Published by F42.08, this standard lists a set of attributes or metadata that are
20 required to accompany in-process monitoring datasets.
21
23  ASTM WK73978, New Specification for Additive Manufacturing – General Principles –

24 Registration of Process-Monitoring and Quality-Control Data (being developed in F42.08)
25  ASTM WK74390, New Practice for Additive Manufacturing of Metals – Data – File structure for
26 in-process monitoring of powder bed fusion (being developed in F42.08)
27  ASTM WK76983 (AKA ISO/ASTM52958) Practice for Additive Manufacturing -- Powder Bed
28 Fusion – Best Practice for In-situ Defect Detection and Analysis. (being developed in F42.05)
29  ASTM WK82605, New Specification for Additive Manufacturing – General Principles – Metal
30 Laser Beam Powder Bed Fusion Machines for Spaceflight Applications (being developed in
31 F42.07).
32
33 As a result of the ASTM CoE Specialty Workshop on In-situ Technology Readiness for Applications in AM
34 Qualification and Certification, ASTM WK82605 was registered in ASTM and subsequently accepted for
35 ISO/ASTM development. This work item identifies significant in situ monitoring categories in section
36 5. They include build chamber oxygen, build chamber temperature and humidity, build chamber
37 pressure, build platform temperature, image capture camera, closed loop control of Z axis controller,
38 recoater motor torque (if applicable), laser power, laser window debris detection, spatter detection, and
1 melt pool monitoring. As illustrated, melt pool monitoring is only one aspect of in situ monitoring. By
2 combining all the in-situ sensor data, the quality of the build cycle can be assessed.
3 Gap PC16: In-Process Monitoring. Few published standards directly address in-process monitoring
4 technologies. More than likely, there will be no “one size fits all” standard for any given additive process,
5 piece of equipment, or material. It would be highly dependent on end user analytics of OEM or
6 internally developed sensing systems.
7 In-process monitoring instrument design, particularly those that have been commercialized, are
8 relatively high TRL, whereas the processing and analysis of the measurement data results (e.g.,
9 identifying flaws) are lower TRL. As such, standards focused on the instrument calibration for
10 repeatability or relating to absolute values such as temperature, or characterization of sensitivity, range,
11 resolution, etc., may likely be developed earlier than those that instruct users on how to process and
12 analyze the measurement data. Additionally, AM in-process monitoring largely utilizes existing
13 instruments (e.g., thermal imagers, machine vision, pyrometry, etc.) which may refer to associated
14 standards developed outside the scope of AM applications (e.g., thermographic standards from ISO/TC
15 135/SC 8, ASTM E20.02, ASTM E07.10, or BSI Group GEL/65/2, or machine vision standards from ISO/TC
16 42 on Photography, European Machine Vision Association (EMVA), Association for Advancing
17 Automation (A3)).
18 Some concepts regarding in-process data preprocessing or organization are known to be critical and can
19 be potentially standardized sooner than guidelines or methods on data analysis. These include
20 alignment or registration of in-process data (e.g., WK74390 and WK73978), and necessary metadata or
21 schema for transferring or archiving in-process data (e.g., F3490-21).
24 Recommendation: For AM machine condition monitoring, issue standards on in-process monitoring.

25 Aspects to explore include but are not limited to the following examples (not a comprehensive list): the
26 feedstock (supply ratios and other metrics), process conditions (atmosphere, humidity), and
27 performance of systems to achieve accurate process parameters (beam diagnostics such as location,
28 laser power, scan width, scan rate).
29 For part quality monitoring, issue standards on alignment and registration of in-process measured data
30 with other data (design geometry, post-fabrication NDE, or other in-process data), methods for
31 calibration or characterization of in-process monitoring instruments, methods for evaluating
32 performance or sensitivity of in-process monitoring systems, guidelines for identifying or labelling
33 certain flaws or anomalies within specific in-process monitoring technologies. Issue guidelines or
34 methods on how to determine critical flaw size, magnitude, or concentration thresholds, or statistical
35 process variables and control limits. See also gap DE9 on the use of physics-based models and simulation
36 tools (analytics).
1 Priority: ☐High; ☒Medium; ☐Low, given the relatively TRL state of the art
2 Organization: ASTM E07.10, F42

5 Repair; ☐Data



14
16 ☐New
17
19 2.2.2.13 Anti-Counterfeiting
20 Quality is compromised when a counterfeit substitutes for a genuine product. Cybersecurity, addressed
21 in Section 2.2.2.11, protects the digital file, but as AM scale-up creates a supply chain, separate
22 measures are necessary for validating physical additively manufactured objects. Industries with concerns
23 about brand protection may wish to consider incorporating identification features into components to
24 deter counterfeiting.
25 Counterfeiting, either economically motivated or for the purpose of sabotage, is facilitated through the
26 ubiquity of 3D printers and the ease of 3D scanning. Anti-counterfeiting measures that rely on surface
27 security features (color, texture, patterns, codes) are vulnerable to a counterfeiter with a 3D scanner,
28 and therefore are not secure choices to protect AM. Covert features, including internal patterns,
29 physical or chemical, and electronic tags, avoid those vulnerabilities. Authentication must strike a
30 balance: easy and inexpensive enough to be viable, but not so easy as to facilitate copying. Care should
31 be taken to align quality management goals so that intentional tagging for anti-counterfeiting purposes
32 is permitted, rather than viewed as contaminated material, and so that testing goals are coordinated
33 where possible.
1 Discontinuities and even voids may be intentionally introduced in order to address the concern of
2 counterfeiting, e.g., by inserting other materials or varying internal texture as a hidden signature. Best
3 practices include:
4  Provision of objective evidence for authentication

5  Good supply chain procedures for added material such as taggants or RFID tags (e.g., multiple
6 suppliers, multiple countries)
7  Non-destructive evaluation for authentication, preferably portable to enable authentication of
8 parts before installation into larger systems
9  The placement of an anti-counterfeiting feature so that it does not compromise structural
10 integrity, e.g., where a void or label would otherwise be acceptable. The feature also needs to
11 survive post-processing.
12
13 See section 2.1.7 Design for Anti-counterfeiting (gap DE29) and section 2.4 on NDE (gaps NDE2 and
14 NDE7).
15 Other Process Control Standards Activity Since Roadmap v2 - Relevance to Sections/Gaps Not
16 Yet Determined
18  ASTM WK72317, Additive Manufacturing -- Powder Bed Fusion -- Multiple Energy Sources
19  ASTM WK77008, Guide for Additive Manufacturing -- Laser Powder Bed Fusion -- Guide for
20 Benchmarking of Powder Bed Density. This is AM CoE project 2102 being developed in F42.01.
21  ASTM WK77236, Specification for Additive manufacturing for aerospace -- Process
22 characteristics and performance -- Part 2: Directed energy deposition using wire and arc (aka
23 ISO/ASTM 52943-2)
24  ASTM WK78110, Guide for Additive Manufacturing -- General Principles -- Development and
25 Roadmapping of Additive Construction Standards
26  ISO/ASTM DTR 52917, Additive manufacturing — Round Robin Testing — General Guidelines
27 (previously ISO 17296-3:2014)
28  ISO/ASTM CD 52927, Additive manufacturing — General Principles – Main characteristics and
29 corresponding test methods
30  ISO/ASTM PWI 52943-1, Additive manufacturing — Process characteristics and performance —
31 Part 1: Standard specification for directed energy deposition using wire and beam in aerospace
32 applications
33  ISO/ASTM PWI 52943-3, Additive manufacturing — Process characteristics and performance —
34 Part 3: Standard specification for directed energy deposition using laser blown powder in
35 aerospace applications
36  ISO/ASTM PWI 52944, Additive manufacturing — Process characteristics and performance —
37 Standard specification for powder bed processes in aerospace applications
1  SAE AMS7102 - High Performance Laser Sintering Process for Thermoplastic Parts for Aerospace
2 Applications (Jan 2019)
3 2.2.3 Post-processing
5 Additive manufacturing consists of a complex series of operations that are required to make a fit-for-use
6 production part. Among the many critical steps are operations that occur after a part is built and before
7 it is ready for qualification, inspection, testing, and certification. These operations as a group are called
8 post-processing. Post-processing differs depending upon the material and part being built and the
9 process used. Considerations include but are not limited to: removing support structures and excess
10 material from the newly built part’s external and internal surfaces, freeing the part from the build plate,
11 heat treatment operation(s) in the case of metal and some polymeric parts, machining of the part to
12 final dimensional tolerances, processing to attain the desired surface finish, and imparting compressive
13 residual stresses on the surface to improve fatigue resistance.
14 ISO/ASTM 52900:2021, Additive manufacturing — General principles — Fundamentals and

15 vocabulary, defines post-processing as a: “process step, or series of process steps, taken after the
16 completion of an additive manufacturing build cycle in order to achieve the desired properties in the final
17 product.” Post-processing procedures include post-build thermal heat treatments, hot isostatic pressing,
18 sealing, chemical treatments, and surface engineering and finishing. Most post-processing methods and
19 standards likely apply to AM materials, though some may not apply to surface finishing due to the thin,
20 complex features that can be fabricated using AM.
21 Post-processing of metal AM components is frequently performed to reduce residual stresses, achieve a

22 more desirable microstructure compared to the as-built part, improve surface finish, reduce internal
23 porosity, meet geometric tolerance requirements, and/or establish desired metallurgical characteristics
24 and mechanical properties.
25 A work item in development is ISO/ASTM DIS 52908, Additive manufacturing — Finished part properties
26 — Post processing, inspection and testing of parts produced by powder bed fusion. Designed to
27 complement ISO/ASTM 52900, this standard covers the testing of components manufactured from
28 metallic materials using additive technologies. It sets requirements for the qualification, quality
29 assurance and post processing for metal parts made by powder bed fusion.
30 Post-processing of polymeric AM components is frequently performed to complete chemical reactions,

31 homogenize microstructure and/or residual stresses compared to the as-built part, improve surface
32 finish, reduce surface porosity, and/or meet geometric tolerance requirements.
33 Post-processing of ceramic AM components is required for improved properties. There are three key
34 factors when considering post-processing in 3D printed ceramics – density, surface quality, and
35 microstructure, which affect the part properties. For binder jetting printed ceramics, the typical post
1 heat treatment process includes binder curing stage, polymeric binder burnout stage, followed by
2 sintering stage for densification.
3 Post-processing is essential to transforming an additively manufactured part into a finished part. In

4 summary, post-processing takes a configured shape, refines its features, and imparts mechanical
5 properties and structure in the case of metal parts.
6 In terms of process control, post-processing must be applied identically from build-to-build to achieve
7 consistent performance for a given AM part. Additionally, post-processing methods used during
8 development and qualification of the AM procedure parameters must be sufficiently representative of
9 the final component post-processing to ensure that the performance data generated during
10 development and qualification are consistent with the final component.
11 Given its effects on the consistency of material and part performance, post-processing should be a key
12 feature of calibration and qualification artifacts. Due to the various means of building AM parts and the
13 unique effects each may have on the final materials, ensuring a consistent method of post-processing
14 calibration articles will provide a method of correlating these artifacts across machines and AM
15 methodologies. This application encompasses all the topics discussed in this section, and for this reason
16 the need for a common post-processing methodology for test artifacts is considered the first gap in this
17 section.
19 Metals

21 Manufacturing. AWS D20.1 requires that the same post-processing operations that will be
22 performed on the production component be performed on the qualification builds (5.2.1.4 -
23 PBF, 5.2.2.4 - DED). Post-build processing parameters are listed as qualification variables in Table
24 5.2 (PBF) and Table 5.3 (DED).
25  SAE AMS7000A, Laser-Powder Bed Fusion (L-PBF) Produced Parts, Nickel Alloy, Corrosion- and
26 Heat-Resistant, 62Ni - 21.5Cr - 9.0Mo - 3.65Nb Stress Relieved, Hot Isostatic Pressed and
27 Solution Annealed (2022-05-16)
31 Metals
32  SAE AMS7016, Laser-Powder Bed Fusion (L-PBF) Produced Parts, 17-4PH H1025 Alloy (Oct 2018)
33  SAE AMS7024, Inconel 718 L-PBF Material specification (Jun 2019)
34  SAE AMS7028, Laser-Powder Bed Fusion (L-PBF) Produced Parts, Titanium Alloy, Ti-6Al-4V Stress
35 Relieved, and Hot Isostatic Pressed (Jan 2020)
1  SAE AMS7030, Laser- Powder Bed Fusion (L-PBF) Produced Parts of AlSi10Mg (Feb 2020)
2  SAE AMS7036, Laser-Powder Bed Fusion (L-PBF) Produced Parts, Steel, Corrosion and Heat
3 Resistant 17Cr – 13Ni – 2.5Mo (316L), Hot Isostatic Pressed (Initiated Mar 09, 2021)
4  SAE AMS7038, Laser-Powder Bed Fusion (L-PBF) Produced Parts, Nickel Alloy, Corrosion and
5 Heat-Resistant -52.5Ni - 19Cr - 3.0Mo - 5.1Cb (Nb) - 0.90Ti - 0.50AI - 18Fe Stress Relieved, Hot
6 Isostatic Pressed, (Initiated Mar 02, 2021)
8 Resistant 17Cr – 13Ni – 2.5Mo (316L), Stress Relief and Anneal (Initiated Apr 19, 2021)
9 Polymers
10  ISO/TC 261/JG 55, Joint ISO/TC 261-ASTM F 42 Group: Standard Specification for Extrusion Based
11 Additive Manufacturing of Plastic Materials [STANDBY]
12 Gap P1: Post-processing Qualification, Validation, and Production Builds. Standards are needed that
13 require post-processing to be applied consistently for qualification, validation, and production builds of
14 AM parts. While a number of standards have been published or are in development that address this
15 issue especially for metals, additional standards work may be needed for other materials and AM
16 processes, to address required part performance.
18 R&D Expectations: Develop scientific basis for best practices
19 Recommendation: New standards and revisions to existing standards should require post-processing for
20 the various materials and AM processes to be applied consistently for qualification, validation, and
21 production builds of AM parts. These standards should be process and material specific and should seek
22 to define minimum best practices for qualification, validation and production builds, along with
23 reporting requirements.
25 Organization: AWS D20, ASTM F42/ISO TC 261 JG 55, SAE, ASME
26 Lifecycle Area: ☐Design; ☐Precursor Materials; ☐Process Control; ☒Post-processing; ☐Finished

28 Repair; ☐Data


5 Current Alternative: Each company is setting their own controls with varying degrees of consistency.
7 ☐New
8 V3 Update: For metals, AWS D20.1 and SAE AMS7000A and AMS7004 have been published and SAE has
9 a number of standards in development. ASME code case 3020 uses the same post weld processing for
10 qualification of additive build procedures (heat treatment, peening, etc.) rules as are used for welds. For
11 polymers, ASTM F42/ISO TC 261 JG 55 is in development for material extrusion but appears to be in
12 Standby according to the ISO/TC 261 website.
13 2.2.3.2 Heat Treatment (metals, polymers)
14 Metals
15 Introduction
16 Post-build heat treatment (HT) subjects the part to specific thermal cycles involving heating and cooling
17 to a specific time/temperature profile at a specified rate. Multiple heat treatments may be sequenced
18 with other post-processing operations such as rough machining and final machining. Heat treatment
19 may be used to reduce residual stresses induced in the part by the AM building process to minimize
20 warping and improve dimensional stability and machinability. It is also used to achieve the desired
21 properties by changing the metallurgical structure (such as improving strength by precipitation
22 hardening), and to create a part with isotropic properties. Heat treatment is frequently done in an inert
23 atmosphere or vacuum, depending on the material involved, to prevent oxidation and deterioration of
24 the properties of the materials.
25 Standards for Heat Treatment of AM Parts
26 Numerous heat treatment standards exist for alloys, many of which can be used for additively
27 manufactured parts, either as-is or with modifications. Existing HT standards specifically address all
28 forms of an alloy such as wrought, forged, cast, etc. but most do not include an additively manufactured
29 variant. The layered build process, fine grain, unique microstructure, and directionally-dependent
30 characteristics may require modified HT schedules to achieve the desired microstructure and properties
31 depending on the material, the AM build process, and the desired properties.
1 Standards on heat treating process equipment, procedures, and HT cycles for various metals currently
2 exist that are specific to wrought or cast metals. There are several standards that give simplified thermal
3 cycles for additively manufactured metal parts of specific materials produced by powder bed fusion
4 (PBF). For example,
5  ASTM F2924-14(2021) - Standard Specification for Additive Manufacturing Titanium-6

6 Aluminum-4 Vanadium with Powder Bed Fusion
8 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
13 However, more standards are needed for other materials and other processes. SAE AMS4999A, Titanium
14 Alloy Direct Deposited Products 6Al - 4V Annealed (2016-09-26) includes thermal processing
15 information. Additional published heat treatment standards which may be applicable for heat treating
16 additively manufactured parts include:
17  ASTM F3301-18a, Standard for Additive Manufacturing – Post Processing Methods – Standard
19  SAE AMS2750G, Pyrometry
20  SAE AMS2759G, Heat Treatment of Steel Parts General Requirements
21  SAE AMS2759/3J, Heat Treatment Precipitation-Hardening Corrosion-Resistant, Maraging, and
22 Secondary Hardening Steel Parts
23  SAE AMS2770R, Heat Treatment of Wrought Aluminum Alloy Parts
24  SAE AMS2771F, Heat Treatment of Aluminum Alloy Castings
25  SAE AMS2774G, Heat Treatment, Wrought Nickel Alloy and Cobalt Alloy Parts
26  SAE AMS2801C, Heat Treatment of Titanium Alloy Parts
31 Manufacturing on Substrate, Ti-6Al-4V, Stress Relieved (Jan 2019)
32  SAE AMS-H-6875C, Heat Treatment of Steel Raw Materials (Stabilized Sep 2020)
33 Another committee with relevant published standards is ISO/TC 17/SC 4, Heat treatable and alloy steels.
10 Resistant 17Cr – 13Ni – 2.5Mo (316L), Stress Relief and Anneal (Initiated Apr 19, 2021)
11  SAE AMS7049, Binder Jet Additive Manufacturing (BJAM) Produced Parts, Steel, 1.0Cr – 0.20Mo
12 – 0.30C, Austenitized, Quenched and Tempered (Composition Similar to UNS G41300) (2022-01-
13 14)
14  SAE AMS7051, Binder Jet (BJAM) Printed Parts, Precipitation Hardenable Steel Alloy, Corrosion
15 and Heat-Resistant, 16.0Cr - 4.0Ni - 4.0Cu - 0.30Nb Solution Annealed and H900 Aged (2022-06-
16 20)
17 Gap P2: Heat Treatment (HT)-Metals. Many of the existing and in-development standards for HT of
18 metals built using PBF state the requirements for a specific metal within the standard, but not all metals
19 have been addressed, and stress relief heat treatments in these standards may not be optimized for AM.
20 In addition, differences between laser-based and electron beam-based PBF processes are insufficiently
21 addressed in the existing standards. Both processes are considered to be the same regarding HT
22 requirements, when in reality PBF-EB is performed at much higher temperature and produces a more
23 uniform microstructure so it may require less or no residual stress relief.
24 Heat treatment requirements for metals made with non-powder processes such as directed energy
25 deposition (DED) using wire feedstock, sheet lamination, etc., are currently not addressed in any
26 standards except for titanium-6Al-4V via DED (SAE AMS7004).
27 HT standards for parts produced using binder jetting are also needed. There are multiple steps to go
28 from the printed part to the sintered part and additional heat treatment cycles. Starting microstructures
29 may be different than for an L-PBF part and may require additional research. The starting microstructure
30 and ending microstructure need to be understood. That will depend on the technology used to print the
31 part.
32 In cases where AM material requires HIP processing, the process may be modified to meet HT
33 requirements as well, negating the need for additional HT standards.
35 R&D Expectations: R&D is needed to determine the optimized heat treatments for AM materials as a
36 function of materials and process.
1 Recommendation: As the need arises for new metals, new standards will have to be written for each
2 one, containing specific HT information. Also, as differences are found in required HT for laser versus
3 electron beam processes, these differences should be added to the existing standard for that metal.
4 Standards for metals made with non-powder (e.g., wire, sheets) or non-melting (e.g., ultrasonic, cold
5 spray, friction stir) processes need to be developed that contain HT requirements specific to that metal
6 and optimized for the appropriate production process. As heat treatments are found to reduce
7 anisotropy in properties for particular metals, these should be added to the existing standards for those
8 metals.
10 Organization: R&D: universities, OEMs, government research labs, and others. Standards development:
11 ASTM F42, SAE AMS-AM, MPIF.

14 Repair; ☐Data


24 ☐New
25 V3 Update: A number of standards have been published and or are being developed since the
26 publication of AMSC roadmap v2.
27 Polymers
28 Introduction
29 Post-build heat treatment (HT) for polymeric materials involves heating and cooling to a specific
30 time/temperature profile at a specified rate. Heat treatment of polymeric materials generally involves a
31 single thermal cycle. In the case of thermoset materials, heat treatment, also known as post-curing (see
1 section 2.2.3.6), is intended to ensure that the reactive chemical components are either consumed by
2 the polymerization reaction or driven from the completed part. In some systems, this heat treatment
3 may also be accompanied by irradiation. In the case of semi-crystalline thermoplastic polymeric
4 materials, heat treatment (annealing) is intended to reduce residual stresses induced in the part by the
5 AM building process to minimize warping and improve dimensional stability and machinability. This is
6 accomplished by allowing the time/temperature profile necessary for the maturation of the crystalline
7 domains in the printed part.
8 Standards for Heat Treatment of AM Parts

9
10 There are currently no identified published or in-development standards on specific heat treatments
11 (heating and cooling rates, anneal conditions) which could guide the AM practitioners to arrive at an
12 optimum anisotropic structure and properties for the polymer parts. ASTM and ISO mechanical test
13 standards which have been commonly-used by various research groups to test the properties of the AM
14 built parts such as tensile and compressive strengths, bending, mechanical fatigue, crack propagation
15 and impact, may have to include a consideration of the influence of microstructure. The physical and
16 mechanical properties of the finished part can be considerably affected by the degree of crystallization
17 of polymers which can be controlled by the change of cooling rate during and after the AM process. A
18 better understanding of the microstructure of the as-deposited polymer is necessary to arrive at the
19 mechanical properties most suited for a given application.
20 Gap P7: Heat Treatment (HT)-Polymers. Heat treatment is an effective method to modify the properties
21 of AM built polymer parts. Presence of fillers, as in the case of composites, can alter the nucleation rate
22 causing significant increase in tensile strength and hardness of the finished part. It also becomes
23 essential to consider the variation of morphology of the polymer parts and layers because of the
24 difference in the cooling rate from the surface to the center. The outer surface could end up less
25 crystalline due to a rapid solidification rate and result in less resistance to wear. The contraction of
26 volume due to crystallization in the bulk could increase the residual stresses at the interface. Standards
27 are needed on specific heat treatments (heating and cooling rates, anneal conditions) which could guide
28 the AM practitioners to arrive at an optimum anisotropic structure and properties for the polymer parts.
30 R&D Expectations: R&D is needed to determine the conditions for optimized heat treatments of AM
31 built parts as a function of materials (semi-crystalline polymers, composites, etc.) and AM post process
32 parameters.
33 Recommendation: As AM expands to include new and high performance semi-crystalline polymers,

34 polymer nanocomposites and thermosets, advanced machine design and processing, the standards for
35 the measurement of mechanical properties will have to describe specific HT information on the test
36 samples. These HT requirements (slow cooled vs. quenched vs. gradient cooled) will be specific to the
37 polymer and the production process. A guideline on HT treatment procedures followed by sampling for
38 testing would enable achieving optimum polymer microstructure and properties.
2 Organization: R&D: NIST, universities, OEMs, government research labs, and others. Standards
3 development: ASTM F42, SAE AMS-AM.

6 Repair; ☐Data


16 ☐New
18 2.2.3.3 Hot Isostatic Pressing (HIP) (metals and ceramics)
19 Introduction
20 Post-build hot isostatic pressing (HIP) involves subjecting the part to a specific thermo-mechanical
21 treatment cycle involving heating it at a specific ramp rate to a specific temperature for a specific period
22 of time, while applying positive isostatic pressure (often in the range of 100-200 MPa) utilizing an inert
23 atmosphere and then cooling it. The HIP cycle is unique to each material and can be optimized
24 depending on the desired properties for the material.
25 HIP is used to reduce porosity and heal defects in metals, effectively increasing the alloy’s bulk density.
26 HIPing can improve the alloy's mechanical properties and workability. HIP is important for additively
27 manufactured parts. HIP improves the fatigue properties by healing internal discontinuities, i.e., not
28 extended to the surface, such as lack of fusion, voids, porosity, and cracks. HIP can often improve the
29 ductility and fracture toughness of the material as well. HIP temperature and soak time can be
30 optimized for producing parts with lower residual stress, uniform microstructure, recrystallized grain
31 size, and morphology closer to the equiaxed grain structure.
1 In modern HIP systems there is the possibility to rapidly cool or quench inside the HIP furnace making it
2 possible to combine the HIP step and the heat treatment for a material in the same cycle in the HIP.
3 With this combined process, it is not only possible to eliminate internal defects in the AM part with
4 HIPing but also to modify the microstructure of the material as desired for optimal mechanical
5 properties just like conventional heat treatment.
6 For ceramics, densification processes, such as warm and hot isostatic pressing are preferred
7 densification methods over uniaxial hot pressing, because of their application to complex-shaped parts,
8 while hot pressing is only suitable for regular-shaped blocks. Another method commonly employed to
9 increase the density of porous ceramics is infiltration. Gas- or liquid-phase infiltration methods include
10 slurry infiltration, sol–gel infiltration, reactive melt infiltration, polymer infiltration and pyrolysis, and
11 chemical vapor infiltration.
12 Density and microstructure are directly influenced by the processing parameters in the post-debinding
13 and sintering, such as heating/cooling rate, maximum temperature, holding duration, atmosphere, and
14 pressure.
15 Standards for HIP of AM Parts
16 There are a number of HIP standards for metals, some of which can be used for additively manufactured
17 parts, either as is or with modifications. These standards are designed for cast, forged metals, billets,
18 and preforms produced by powder metallurgy technology, sintered components, or metal injection
19 molded parts, and should not therefore be automatically considered for additively manufactured parts.
20 In order to maximize AM material integrity without compromising microstructure properties
21 relationships, the HIP parameters need to be optimized, especially for structural, flight safety parts, and
22 other demanding applications.
24 ASTM Committee F42 standards that contain specific HIP process parameters14 for specific metals
25 include:

31 Additive Manufacturing Processes
14
HIP parameters for Titanium, Aluminum, and superalloys (which includes Inconel) are classified as export
controlled. Transfer of these parameters from companies to SDOs to include in standards is a matter of concern for
some U.S. companies.
5  ASTM F3301-18a, Standard for Additive Manufacturing – Post Processing Methods – Standard
7 Other ASTM standards include:
8  ASTM A988/A988M-17, Standard Specification for Hot Isostatically-Pressed Stainless Steel

9 Flanges, Fittings, Valves, and Parts for High Temperature Service
10  ASTM B998-17, Standard Guide for Hot Isostatic Pressing (HIP) of Aluminum Alloy Castings
11 SAE AMS-AM standards that contain specific HIP process parameters for specific metals include:
12  SAE AMS4999A, Titanium Alloy Direct Deposited Products 6Al - 4V Annealed (2016-09-26)
17 Manufacturing on Substrate, Ti-6Al-4V, Stress Relieved (Jan 2019)
19  SAE AMEC AM2750/2, Pyrometry for Hot Isostatic Pressing

31 – 0.30C, Hot Isostatic Pressed, Austenitized, Quenched and Tempered (Composition Similar to
32 UNS G41300) (2022-01-14)
33 Gap P3: Hot Isostatic Pressing (HIP). Just as for heat treatment and gap P2, the existing HIP standards
34 do not fully address AM material-related issues such as: slow cooling rate and its effect on formation of
35 prior particle boundaries and carbide precipitation at grain boundaries, as well as the effect of thermal
36 exposure on excessive grain growth, carbide size, incipient melting, and the effect of removing the part
1 from the base plate before HIP (in the case of PBF). The HIP parameters in the existing AM standards are
2 often developed for castings, forgings and sintered parts and may not be optimal for AM material since
3 the thermal history, as-printed microstructure and property requirements often is a lot different from
4 materials processed with the conventional manufacturing methods. Generally, the existing standards
5 provide guidance for interpretation of processing parameters, tolerances, and conformance to industry
6 accepted practices such as pyrometry, cleanliness, traceability, etc.
9 Recommendation: Develop material specific standards based on R&D defined HIP parameters for AM
10 with acceptance criteria for internal discontinuities. Some examples are listed below. It is recognized
11 that this will be difficult to achieve as each material will have parameters that are applicable and those
12 could change as a result of application requirements that are related not just to pores but also to
13 microstructure. It should be possible to develop a standard that defines acceptable end results defined
14 by some of the attributes listed here.
15  Effect of max thermal exposure on microstructure evolution (X temperature for more than X hours)
16  Effect of cooling rate
17  Discontinuities extended to the surface
18  Incipient melting with and without voids
19  Discontinuities larger than X inches depending on location
20  Lack of fusion
21  Interconnected porosity
22  Nonmetallic contamination
23  Cross contamination due to processing of different customer parts in commercial HIP vessels
24  Grain morphology
25  Material dependent microstructure (e.g., in 718 laves phase, delta phase morphology, etc.)
26  Number of discontinuities larger than X in per certain view area (e.g., within 1 sq. inch)
27  Number of discontinuities in subsurface area (X microns from the surface) larger than X inch
28  Linear formation of discontinuities (other than interconnected porosity) and minimum distance of X
29 inches between adjacent discontinuities
31 Organization: R&D: various entities. Standards: ASTM F42, SAE AMS-AM, possibly SAE AMEC

34 Repair; ☐Data

10 ☐New
11 V3 Update: Some R&D is taking place in the commercial sector and at the university level. In terms of
12 standards development, the referenced ASTM F42 work items may address the gap. SAE AMS7000A was
13 published in 2022 and SAE AMS AMEC is working on a HIP spec, as noted in the text.
14 2.2.3.4 Surface Texture (Surface Finish) (metals, polymers, and ceramics)
15 Introduction
16 Sometimes referred to as surface finish or topography, surface texture15 is defined in ASME B46.1-2019,
17 Surface Texture (Surface Roughness, Waviness, and Lay), as: “the composite of certain deviations that
18 are typical of the real surface. It includes roughness and waviness.” Surface texture is a very important
19 consideration for AM post processing as most processes create unique surface textures that may require
20 post-build finishing, depending on the application. These include as-built surface asperities such as
21 partially fused powder, a degree of striation or stair-stepping typical of layered deposition on an inclined
22 surface, and/or visible layer lines along vertical surfaces. Moreover, components may present different
23 types of surfaces based on their orientation with respect to the build plate. For example, top surfaces at
24 0° with respect to the build plate will have the characteristic features of the applicable fusing method
25 such as a source pass pattern. At the same time, the overhang or downskin regions can show significant
26 material accumulation, dross formation or the remains of fused support structures. In addition, non-
27 optimized surface parameters, such as a mismatch between core and surface (e.g., contour, upskin,
28 downskin) beam scanning patterns could potentially produce very small voids or areas filled with un-
29 melted powder or un-reacted resin, resulting in subsurface porosity and/or lack of fusion. Some
30 processes, such as DED processes using wire feedstock, display a surface typical of weld-clad surfaces
31 often requiring 100% machining to achieve a finished component. Material selection also significantly
32 impacts surface texture, especially in polymer parts. For example, ABS typically prints in a dull finish,
15
Not to be confused with crystallographic texture
1 while polylactic acid (PLA) is semi-transparent, often resulting in a glossy and smooth finish. Ultimately,
2 final surface texture is a complex function of material and process parameters including: type of AM
3 process, process parameters (such as beam power, build speed, hatch distance), material type,
4 characteristics of feedstock (such as powder particle size distribution and morphology), layer thickness,
5 and build orientation.
6 Both surface asperities and subsurface porosity significantly reduce fatigue and fracture properties.
7 Metals, such as Ti-6Al-4V, manufactured using PBF have exhibited reduced fatigue life with increased
8 surface roughness. This is a direct consequence of higher stress concentrations at surface features that
9 can act as micro-notches. Surface defects (such as surface asperities, surface breaking porosity, or
10 poorly fused particle boundaries) and complex internal passages can also entrap fluid or gas during
11 service which can significantly contribute to corrosion. Similarly, these features can entrap solvents,
12 abrasive slurry, abrasive pastes, or chemical etchants used for post processing, thereby complicating the
13 surface finishing process. While these concerns are relevant to most AM materials and properties, low
14 surface roughness can be especially important to ceramic parts as it minimizes the potential of surface
15 crack initiation under mechanical load. Unfortunately, because of the high hardness of sintered
16 ceramics, direct machining or grinding of sintered ceramics is challenging and expensive and optimizing
17 the surface finish of the as-built part may be necessary. One potential solution is to use fine ceramic
18 particles, as particle size significantly affects the surface texture.
19 Standards for Surface Finish of AM Parts
20 The unique surfaces of AM parts create many challenges to the standardization of surface finishing
21 techniques. Many conventional surface measurement techniques struggle to measure rapid changes in
22 surface height and cannot be run on some AM parts without significantly reduced speed, resolution, or
23 risk to the machine. More importantly, most techniques are only capable of measuring the highest point
24 of the surface and are therefore incapable of measuring overhangs or some internal features. These are
25 often the most critical aspect of surface texture for AM parts, however, as they contribute the most to
26 part properties. But, even if one manages to measure these overhangs, current equations for calculating
27 surface texture parameters do no not allow for such data. Current standards should be expanded to
28 allow for these calculations but until then producers may need to remove overhangs through sufficient
29 surface finishing for parts where that is critical. Standards for reliable NDT methods, such as CT scan
30 with high resolution for evaluation of internal passages’ surface roughness, are also needed.
31 Complex curved surfaces, re-entrant features, or lattice structures, easily designed and produced by AM
32 processes, can challenge common finishing methods. The amount of material removed around these
33 features will likely not be uniform but there are currently no standards to either ensure it is or to
34 account for this difference in part design. For many applications, a significant amount of material
35 removal is necessary. For instance, in PBF, the total thickness of material removal that includes both
36 surface asperities and subsurface porosity can be estimated to exceed 250 microns or ~0.010 inch;
37 however, it can be higher. Ensuring this does not deteriorate material integrity, such as through
38 intergranular attack (IGA)/Integranular Oxidation (IGO), can be challenging, especially for internal
1 surface polishing of surface asperities and subsurface porosity which often require chemical polishing
2 methods. Standards capable of striking this balance are necessary. Other important considerations
3 include edge retention, surface roughness variation throughout the length of internal passages, extent
4 of bell mouthing in internal passages, and achieving the required final surface roughness values.
5 Methods to minimize or account for these concerns are needed.
7 Definitions and interpretations of surface finish specifications are included in the standards listed
8 below.
Standard Title
ASME B46.1-2019* Surface Texture (Surface Roughness, Waviness, and Lay)
ASME Y14.36-2018 Surface Texture Symbols
ISO 21920-1:2021 Geometrical Product Specifications (GPS) - Surface Texture: Profile - Part
1: Indication Of Surface Texture
ISO 21920-2:2021 Geometrical Product Specifications (GPS) - Surface Texture: Profile - Part 2:
Terms, Definitions And Surface Texture Parameters
ISO 25178-1:2016 Geometrical Product Specifications (GPS) – Surface Texture: Areal – Part
1: Indication of surface texture
2: Terms, definitions and surface texture parameters
SAE AS291F-2014 Surface Texture, Roughness, Waviness and Lay (Stabilized: Sep 2014)
9 *Contains additional information beyond definitions, such as measurement methods, instrument

10 classification, etc.
11 There are numerous methods available for measuring the texture of a surface, including non-contact
12 and contact approaches. Present standard test methods and guides for measuring surface finish are
13 listed in the table below. These are applicable to a variety of materials, though none are specific to
14 those produced via AM.
15 Validation of surface finish may be particularly difficult on wire-like features. The list below will likely
16 apply to planar or wide surfaces; thin wires do not lend themselves to stylus techniques, and other
17 methods may be required.
Standard Title
ASME B46.1-2019 Surface Texture (Surface Roughness, Waviness, and Lay)
ASTM D4417-21 Standard Test Methods for Field Measurement of Surface Profile of Blast
Cleaned Steel
ASTM D7127-17 Standard Test Method for Measurement of Surface Roughness of
Abrasive Blast Cleaned Metal Surfaces Using a Portable Stylus Instrument
ISO 8503-2:2012 Preparation of steel substrates before application of paints and related
products - Surface roughness characteristics of blast-cleaned steel
substrates - Part 2: Method for the grading of surface profile of abrasive
blast-cleaned steel - Comparator procedure
ISO 21920-3:2021 Geometrical Product Specifications (GPS) - Surface Texture: Profile - Part
3: Specification Operators
3: Specification operators
6: Classification of methods for measuring surface texture
NACE SP0287-2016 Field Measurement of Surface Profile of Abrasive Blast-Cleaned Steel
Surfaces Using a Replica Tape
MPIF Standard Test Method for Determination of Surface Finish of Powder Metallurgy (PM)
Method 58 Products
SAE AMS 03-2C-2020 Cleaning and Preparation of Metal Surfaces
SAE J911 Surface Texture, Roughness (Ra), Peak Count (Pc), and Mean Profile
Spacing, (Rsm) Measurement of Metallic Coated and Uncoated Steel
Sheet/Strip to be Formed and/or to be Painted
1
2  Additionally, ISO 25178-601, -602, -603, -604, -605, -606 and -607 define nominal characteristics
3 of various types of instruments for surface texture measurement. ISO 16610-1, -20, -21, -30, -31,
4 and -40 define various methods for filtering data.
5  ASME B5 Technical Committee 65 on Micromachining also is working on post-processing.
6  To physically achieve a specific surface texture, there are numerous methods available. These
7 include mechanically abrasive techniques, electro-chemical polishing, micro-machining,
8 chemical and thermal techniques.
9  Mechanical techniques such as shot peening or media blasting (e.g., ASTM B851-04(2020) and
10 F1330-91(2018), respectively and SAE AMS2430U:2018, Shot Peening, Automatic) can likely be
11 applied easily to AM materials, but may require investigation into their effects on fatigue life
12 when the work hardening effects become significant.
13  Non-abrasive methods, such as electropolishing, chemical etching, or chemical-mechanical
14 polishing may also be applicable to AM materials, as these are more dependent on material
15 chemistry. The specifications available for these methods are extensive, and the individual
16 standards will not be listed here; see publications from ASTM Committee B08 and ISO/TC 107,
17 both on metallic and inorganic coatings, for more information.
18  Solvent vapor smoothing may be applied to some polymeric AM materials. The process is highly
19 dependent on the solvent and material chemistry. Vapor smoothing can address many
1 geometries that abrasive methods cannot, however it can cause warping in thin areas of the
2 piece.
3  Organic coatings, (primers, paints, dyes, etc.) can be employed to improve the aesthetics, or
4 provide enhanced textures such as rubberized painted. There are currently no standards
5 associated with these finishing properties.
6  Requirements for surface finish in ASTM standard specifications (e.g., ASTM F2924-14(2021),
7 F3001-14(2021), F3055-14a(2021), and F3056-14e1(2021) leave surface finish to agreement
8 between the component supplier and purchaser and lack specific recommendations.
10  AMPP TR21522, Corrosion Testing for Additive Manufacturing

11  ASTM WK66682, Evaluating Post-processing and Characterization Techniques for AM Part
12 Surfaces (initiated 01-22-2019)
13 Gap P4: Surface Texture (Surface Finish). Unique features, such as helixes, spirals, lattice structures, and
14 internal surfaces and cavities, can be manufactured using AM versus subtractive machining. However,
15 the applicability of current measurement methods to the surface of these features is not clear or
16 captured in standards. For example, features such as helixes or lattices may produce wire-like structures
17 that are not as easily measured using stylus instruments as flat surfaces.
18 Also, the suitability of current specification methods must be investigated for AM.
19  ASME Y14.36-2018, Surface Texture Symbols may be sufficient, but further investigation is required
20 to determine if AM-specific symbols are necessary (e.g., to control stair-stepping or allowable
21 surface porosity).
22  Furthermore, although there are methods available for finishing AM materials, many lack standard
23 practices. Some methods require material removal, such as chemical polishing or abrasive
24 techniques, and it is not known at this time how to accommodate this in AM product specifications
25 in a standard form. Other methods require the addition of material, such as electroplating and
26 coatings but it is also unknown how to accommodate these into AM standards.
27  Lastly, as the effects of surface finish on performance become more apparent, material specification
28 recommendations must go beyond “supplier and purchaser agreement,” specifically for as-built,
29 non-machined surfaces.
32 that AM CoE Project 1802 (WK66682) addresses AMSC gap P4.
33  Standards for reliable NDT, such as XCT, for evaluation of internal passages
34  Guidance for validation of surface finish on complex features (such as wires or non-planar surfaces).
35 This is a big gap. How is the surface finish or residual stress determined on a surface that is not
36 accessible?
1  Investigation of mechanical techniques such as shot peening or media blasting and their effect on
2 fatigue life for AM materials. There is some work already performed in this area. As expected,
3 compressive stresses are beneficial with respect to fatigue life/limits and corrosion resistance. This
4 is a subject that is being addressed in the AMPP TR21522 report with respect to corrosion fatigue.
5
6 Recommendation: Verify if there are certain measurement methods more appropriate to AM-unique
7 features than a stylus approach such as optical 3D scanning. If so, they should be reviewed for their use
8 on AM materials and appropriate standards written.
9  The applicability of existing surface texture symbols to AM materials should be investigated.

10  Available finishing methods should be reviewed for their effects on final material properties, and
11 improved with standardized practices or guidelines where none exist.
12  An AM standard is needed to improve the surface roughness of very complex internal passages like
13 heat exchanger cores but also for uniform material removal of the internal passages to remove
14 partially melted particles and surface asperities.
16 Organization: ISO/ASTM; ASME (B46 project team 53 on surface finish), IEEE-ISTO PWG, NIST

19 Repair; ☐Data

22 Material Type: ☐All/Material Agnostic; ☒Metal; ☒Polymer; ☐Ceramic; ☐Composite

28 V3 Status of Progress: ☒Green for R&D (metals); ☐Yellow; ☐Red; ☐Not Started; ☒Unknown for
29 Standards (metals and polymers); ☐Withdrawn; ☐Closed; ☐New.
30 V3 Update: The ASME B46 committee, through their project team on Surface Finish for AM (PT53),
31 continues to assess the latest research, knowledge gaps, and industry needs as they evolve with the
32 rapidly growing AM technologies. The latest edition of the ASME B46.1 standard, which was approved
33 by ANSI in 2019, contains subsection B-5 “Surface Texture of Parts Fabricated by Additive
1 Manufacturing” as part of Nonmandatory Appendix B focusing on control and production of surface
2 texture. Current priorities for PT53 are clarifying terminology in the B46.1 standard to create a better
3 measurement and data handling procedures when working with AM surfaces, educating the research
4 community on the methods described, and increasing the range of measurement instruments described
5 (e.g., x-ray computed tomography (XCT)).
6 2.2.3.5 Machining (metals, polymers)
7 The specifications and standards for machining of AM parts are comparable to those for machining
8 other semi-finished parts such as castings. This being the case, existing standards are adequate for
9 machining AM parts. As new “designed for AM” parts become a reality, standards may require
10 modification or new ones may have to be written. No gaps have been identified at this time.
11 2.2.3.6 Post-curing Methods (polymers)
12 Some AM processes produce cured polymers that require a secondary post-cure operation to further
13 advance crosslinking and reduce outgassing (thermal vacuum stability) and offgassing (toxicity). The
14 increased crosslinking from post-curing can result in improved properties of polymer parts. These
15 include increased stiffness, better chemical resistance, higher temperature stability, reduced toxicity
16 (due to reduction of unreacted constituents), or increased strength. The reduced outgassing of the
17 polymer parts influences their dielectric properties (e.g., relative permittivity and loss factor) by directly
18 influencing plastic density, ion viscosity, or increasing dipole relaxation.
19 Unlike the many traditional polymer processing methods AM cures the deposited plastics selectively
20 layer by layer using various methods such as heated jets, binders, focused ultraviolet radiation, or laser
21 heating. In these processes the polymerization reaction can be incomplete affecting the final part
22 performance (i.e., degradation or warpage), especially if these materials are exposed to sunlight or
23 other radiation sources during use or storage.
24 Before post-curing, polymer parts are often rinsed to remove unreached resin from the surface.
25 Typically, this is done to improve the surface finish and remove “sticky” resin, making the parts safer to
26 handle. The effect of the rinse, due to the absorption of solvent on mechanical properties and
27 dimensional accuracy, is unknown, and insufficient post-rinse drying is known to affect dimensional
28 accuracy.
29 In addition, an evaluation of the toxicity resulting from uncured reagents in liquid resins used during
30 processes such as Vat Photopolymerization (e.g., SLA) would also be warranted to ensure product and
31 environmental safety during and after production.
32 Ultimately, these unique risks warrant special post-cure considerations for polymers produced using
33 AM.
34 The Methods
1 Post-curing methods ultimately depend on the underlying chemical processes (photo polymerization,
2 thermosetting) used to initiate polymerization. Manufacturers commonly provide recommendations for
3 post-cure conditions, which are based on the cure kinetics of the polymer and desired end properties.
4 While it is desirable to measure the total degree of cure and hence the cross-link density of the finished
5 part, almost all methods (physical, chemical, mechanical and dielectric) depend on a destructive
6 sampling scheme. These methods include glass transition temperature (Tg), differential scanning
7 calorimetry (DSC), thermogravimetric analysis (TGA), thermomechanical analysis (TMA), dynamic
8 mechanical analysis (DMA), and dielectric response. Many of the standards applicable to the traditional
9 polymer industry are also applicable to AM. These are listed in the following section.
10 For a non-destructive testing of the cured state of the manufactured part, optical density measurements
11 or surface fourier transform infrared (FTIR), as used in certain cases of cross-linked polymers, may be
12 applied. Optical measurements would also help to characterize voids and void density and entrapments.
13 A full implementation of this technique, however, would depend on the overall thickness/diameter of
14 the parts and requires further R&D.
15 Published Standards and Guidance Documents
16 Methods for measuring the above properties are listed below. Often, these methods require a reference
17 standard for comparison to gauge cure completion. Also included are methods aimed at the storage of
18 plastics that undergo photopolymerization, which may impact the handling of AM materials.
Committee Standard Title

ASTM MNL45-
ASTM D01 Radiation Curing of Coatings (Koleske JV)
EB
ASTM D3732- Standard Practice for Reporting Cure Times of Ultraviolet-Cured
ASTM D01.55
82(2017) Coatings
ASTM D5403- Standard Test Methods for Volatile Content of Radiation Curable
ASTM D01.55
93(2021) Materials
Standard Test Methods for AC Loss Characteristics and Permittivity
ASTM D09.12 ASTM D150-22
(Dielectric Constant) of Solid Electrical Insulation
ASTM D257- Standard Test Methods for DC Resistance or Conductance of
ASTM D09.12
14(2021)e1 Insulating Materials
ASTM D4473- Standard Test Method for Plastics: Dynamic Mechanical Properties:
ASTM D20.10
08(2021) Cure Behavior
ASTM D20.10 ASTM D638-22 Standard Test Method for Tensile Properties of Plastics
Standard Test Method for Thermal Flow, Cure, and Behavior
ASTM D3795-
ASTM D20.30 Properties of Pourable Thermosetting Materials by Torque
20
Rheometer
ASTM D4526- Standard Practice for Determination of Volatiles in Polymers by
ASTM D20.70
20 Static Headspace Gas Chromatography
Standard Test Method for Glass Transition Temperature (DMA Tg)
ASTM D7028-
ASTM D30.04 of Polymer Matrix Composites by Dynamic Mechanical Analysis
07(2015)
(DMA)
ASTM E595- Standard Test Method for Total Mass Loss and Collected Volatile
ASTM E21.05
15(2021) Condensable Materials from Outgassing in a Vacuum Environment
ASTM E1559- Standard Test Method for Contamination Outgassing
ASTM E21.05
09(2022) Characteristics of Spacecraft Materials
ASTM E2160- Standard Test Method for Heat of Reaction of Thermally Reactive
ASTM E37.01
04(2018) Materials by Differential Scanning Calorimetry
ASTM E2550-
ASTM E37.01 Standard Test Method for Thermal Stability by Thermogravimetry
21
Standard Test Methods for the Assignment of the Glass Transition
ASTM E2602-
ASTM E37.01 Temperature by Modulated Temperature Differential Scanning
22
Calorimetry
ASTM E1356- Standard Test Method for Assignment of the Glass Transition
ASTM E37.10
08(2014) Temperatures by Differential Scanning Calorimetry
ASTM E37.10
22 Temperature by Thermomechanical Analysis
ASTM E37.10
18 Temperature By Dynamic Mechanical Analysis
ASTM E1824- Standard Test Method for Assignment of a Glass Transition
ASTM E37.10
19 Temperature Using Thermomechanical Analysis: Tension Method
ASTM F2042- Standard Guide for Silicone Elastomers, Gels, and Foams Used in
ASTM F04.11
18 Medical Applications Part II – Crosslinking and Fabrication
ISO/TC 51/SC ISO Plastics - Epoxy Resins - Determination Of Degree Of Crosslinking Of
12 14322:2018 Crosslinked Epoxy Resins By Differential Scanning Calorimetry (DSC)
Pipes And Fittings Made Of Crosslinked Polyethylene (Pe-X) -
ISO/TC 138/SC ISO
Estimation Of The Degree Of Crosslinking By Determination Of The
5 10147:2011
Gel Content
1
2 Published Standards that are specific to additive manufacturing include:
3  ASTM F3091/ F3091M-14(2021), Standard Specification for Powder Bed Fusion of Plastic
4 Materials
5  ISO/ASTM 52903-1-20 Additive manufacturing — Material extrusion-based additive
6 manufacturing of plastic materials — Part 1: Feedstock materials
7  ISO/ASTM 52903-2-20 Additive manufacturing — Material extrusion-based additive
8 manufacturing of plastic materials — Part 2: Process equipment
10 Gap P5: Use of Post-cure to Reduce Toxic Gases from Uncured Polymer Feedstock. An evaluation of the
11 toxic gases resulting from uncured reagents in liquid resins used during processes such as Vat
12 Photopolymerization (e.g., SLA) would be warranted to ensure product and environmental safety during
13 and after production.
2 Recommendation: Augment existing standards with AM-specific recommendations for processes that
3 utilize liquid resins. Evolved gas analysis, an analytical method by which the amount and characteristics
4 of the volatile products released by an AM-built part under controlled temperature variation, is
5 recommended for finished product safety and toxicity. To analyze evolved gas quantitatively,
6 parameters such as sample chamber volume, thermal/vacuum conditions for releasing/analyzing the
7 volatiles and the techniques for the analysis need to be specified.
9 Organization: ASTM D20, ISO/TC 261/ASTM F42

12 Repair; ☐Data

17 Extrusion; ☐Material Jetting; ☐Powder Bed Fusion; ☐Sheet Lamination; ☒Vat Photopolymerization

22 ☐New
23 V3 Update: Standards that have been published or reapproved since the release of version 2 are noted
24 in the text.
25
26 Gap P6: Guidelines for Post-curing AM Plastics to Address Outgassing and Offgassing. Guidelines for
27 evaluating the degree of polymerization and outgassing in AM parts, its effect on part properties, and
28 the effects of post-polymerization treatments on them, have not been established specifically for AM
29 materials. The voids and entrapments that can form in these technologies likely warrant greater testing
30 or modified procedures compared to traditional methods.
1 R&D Expectations: Standard procedures for measuring the degree of polymerization and outgassing
2 (thermal vacuum stability) and performance data for some materials may be archived in NASA’s
3 Materials and Processes Technical Information System (MAPTIS). In space systems, materials typically
4 undergo outgassing testing for use in external environments and offgassing testing for use in crewed
5 environments.
6 Recommendation: Extend existing methods with AM-specific recommendations.
8 Organization: ASTM E21.05, ASTM D20, ISO/TC 138, ISO/TC 261/ASTM F42

11 Repair; ☐Data


20 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☒Not Started; ☒Unknown; ☐Withdrawn; ☐Closed; ☐
21 New

23
24 2.2.3.7 Environmental, Health, and Safety (EHS) Hazards of Post-Processing
25 It is unknown whether there are any environmental, health, or safety hazards that are unique to
26 additive manufacturing post-processing tasks.
28 While there are some existing general standards for health and safety (e.g., machine guarding), it is
29 unknown if these are sufficient to cover environmental, health, and safety issues related to any unique
30 post-processing tasks.
2  ISO/ASTM FDIS 52931 Additive manufacturing of metals — Environment, health and safety —
3 General principles for use of metallic materials. This standard that deals with metal powder
4 addresses limited aspects of post-processing tasks for PBF processes.
5 New Gap P8: EHS Hazards Related to Post-Processing Tasks. In general, there are some existing general
6 standards for health and safety (e.g., machine guarding), but it is unknown if these are sufficient to
7 cover environmental, health, and safety issues related to any unique post-processing tasks encountered
8 in additive manufacturing.
10 R&D Expectations: Detailed hazard assessments are needed for all post-processing tasks to determine
11 whether there are environmental, health, and safety issues for post-processing tasks that are unique to
12 additive manufacturing.
13 Recommendation: Conduct post-processing task hazard analyses and determine the need to develop
14 standards for any hazards that are unique to additive manufacturing.
16 Organization(s): Gov’t agencies: NIOSH, EPA (for R&D). ASTM F42.06, ISO TC 261 (for standards).

19 Repair; ☐Data


29 ☒New
1 2.2.4 Finished Material Properties
3 Finished materials properties characterization for AM parts is necessary in order to meet the required
4 performance. This final characterization stage is focused on the result of significant due diligence
5 employed in every aspect of the AM process chain (i.e., precursor material, process control, post-
6 processing). As such, establishing standards to quantify the final products’ properties/performance is
7 crucial for the wider implementation of AM technology. The expected deployment of AM to produce
8 low volumes of complex products emphasizes the need for standards that are less dependent on large-
9 scale testing, the assumptions of homogenous location-specific properties, or isotropic material
10 behavior. Rather, embracing the inherent heterogeneities in AM and developing standards that can
11 quantify various properties and such heterogeneities before and after post-processing is key and
12 enables wider utilization of the unique characteristics of AM parts/components. Towards this goal, the
13 discussion in this section identifies various areas that can be used to define the characteristics of
14 finished AM parts/components and hence provide recommendations for future standards development
15 through a gap analysis.
16 The following topics are addressed within this section: material properties, component testing;
17 biocompatibility of medical AM parts; removal of AM feedstock from medical AM parts; chemistry;
18 material allowables; microstructure; and AM defect structures.
19 2.2.4.1.1 Finished Material Properties Terminology
20 The terms Material Allowable and Design Value are used throughout this section of the roadmap. Below
21 are some definitions of how these terms are defined for in key aerospace industry documents.
22 For metals, the following definitions have been approved by the MMPDS General Coordination
23 Committee for inclusion in MMPDS Volume II, Appendix A, targeted for publication on/about 1 July
24 2023.
25 Material Allowable —A bulk material property derived from the statistical reduction of data
26 from a stable process. The amount of data required to derive these values is governed by the
27 statistical significance (or basis) and methods defined in Chapter 9. Application of material
28 allowables may require additional considerations for use in design.
29 Design Value —A material property that is established to represent the finished part property.
30 These numbers are typically based on material allowables and adjusted, using building block
31 tests as necessary to account for the range of part geometric features (e.g., holes, notches,
32 surface finish) and in-service environmental conditions (e.g., temperature, moisture, and fluid.)
33 Design values are used in analysis compute structural design margin (i.e., margin of safety.)
34 Influence Factor —Use-case specific factors that affect the mechanical performance of a
35 material. Examples include, but are not limited to, build direction, load orientation, surface
36 condition (as-built, machined, shot peened, surface finish, et.al.) temperature, humidity, coating
1 (anodized, plated, et.al.), etc. Volume II will publish information and guidance on specific
2 Influence Factors similar to the precedent of MMPDS Volume I. Some documents call this a Scale
3 Factor.
4 Similarly, the following definitions appear in the Aerospace Industries Association’s Recommended
5 Guidance for Certification of AM Components (February 2020) which deals with metal AM components
6 fabricated using PBF and DED:16
7 Material Allowable: Material values that are determined from test data of the bulk material on
8 a statistical basis. Allowable development approaches are established via industry standards
9 such as MMPDS or company specific methodology and are based on testing conducted using
10 accepted industry or company standards.
11 Design Value: Material properties that are established from test data on a statistical basis and
12 represent the finished part properties. These values are typically based on material allowables
13 and adjusted, using building block tests as necessary, to account for the range of part specific
14 features and actual conditions. Design values are used in analysis to compute structural design
15 margin (e.g., margin of safety).
16 For non-metallic and composite materials, CMH-17 does not have the same set of definitions as MMPDS
17 but generally agrees on them. Currently, CMH-17 has adopted the following definitions (Volume 1,
18 revision H, 2022):
19 Allowables – Material values that are determined from test data at the laminate or lamina level
20 on a probability basis (e.g., A or B basis values, with 99% probability and 95% confidence, or 90%
21 probability and 95% confidence, respectively). The amount of data required to derive these
22 values is governed by the statistical significance (or basis) needed.
23 CMH17 Clarifying Note: The definition presumes a stable and repeatable fabrication process.
24 Further, the percentage probability, for a given statistical distribution, defines the
25 percentage of the population that will fall above the calculated allowable value. The
26 confidence percentage is based on the number of observations (test data points) available to
27 determine the distribution. In general, the more observations, the more confidence there is
28 in the derived allowable, and therefore the higher the calculated allowable value.
29 Design Values – Material, structural elements, and structural detail properties that have been
30 determined from test data and chosen to assure a high degree of confidence in the integrity of
31 the completed structure. These values are most often based on allowables adjusted to account
32 for actual structural conditions and used in analysis to compute margins-of-safety.
16
Aerospace Industries Association, Recommended Guidance for Certification of AM Component, AIA Additive
Manufacturing Working Group, February 2020, Appendix A, page 36, Accessed 2/16/2023 https://www.aia-
aerospace.org/wp-content/uploads/AIA-Additive-Manufacturing-Best-Practices-Report-Final-Feb2020.pdf
1 CMH17 Clarifying Note: This definition presumes that structural configurations, damage, and
2 environmental criteria that are program-unique are also covered.
3 It is recognized that there are differences in how terms are used between industry sectors and some
4 sectors (e.g., medical) may not use these same terms at all.
5 For purposes of this roadmap, a Material Allowable is the result of analyzing data for bulk material
6 based on test coupons and a Design Value is the number that is used to compute the final margin of
7 safety and includes all the application specific Influence Factors. Design Values are a function of Material
8 Allowables and Influence Factors.
9 New Gap FMP6: Finished Material Properties Terminology. There is inconsistency in how terms (e.g.,
10 material allowable, design value, material strength properties) are defined and used to describe design
11 decisions that will inform finished material properties for metallic and non-metallic additively
12 manufactured parts across industry sectors.
15 Recommendation: Encourage greater consistency in terminology used to establish finished material

16 properties for metallic and non-metallic additively manufactured parts in future revisions of industry
17 standards and guidance materials. The MMPDS and CMH-17 handbooks are accepted industry resources
18 for the aerospace sector.
20 Organization: SDOs
21 Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☒Finished

23 Repair; ☒Data

25 ☐Energy; ☐Medical; ☒Spaceflight; ☐Other (specify) ______________________
29 Q&C Category: ☒Materials; ☐Processes/Procedures; ☐Machines/Equipment; ☒Parts/Devices;

1 V3 Status of Progress: Green; ☐Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☐Closed; ☒
2 New
3 2.2.4.2 Material Properties
4 Introduction
5 Mechanical properties include: yield strength, ultimate tensile strength, reduction in area, elongation,
6 Young’s modulus, compression strength, shear strength, bearing strength, fracture toughness, fatigue
7 strength, fatigue crack growth rate, creep strength, and many others. Depending on the geometry of the
8 component, a difference in properties between the test piece and the component may exist. The load
9 bearing capabilities of a part/component must meet certain mechanical properties limits for certain
10 applications. Most commercial forms of wrought metal products and composites are manufactured to
11 specifications that require lot-release minimum mechanical properties, while most plastics have typical
12 mechanical properties reported by their manufacturers. Because properties of plastics are not
13 guaranteed, typical design practice uses a larger safety factor for plastic parts than for metal. Therefore,
14 for AM parts it would be ideal to have standards with guaranteed mechanical properties rather than
15 with typical properties. However, determining guaranteed properties usually requires an assumption of
16 uniform chemistry, uniformity of bulk material structure, uniformity of post-processing, and the
17 variation in the microstructure. Defects (percentage, distribution, and morphology) in AM metal
18 deposits defies these typical assumptions of uniformity in the bulk material. The material chemistry and
19 AM processing conditions (including post-processing) drives the microstructure and defect levels, and
20 the microstructure and defect levels drive the properties. The processing conditions of each individual
21 build can be unique, based on variations associated with feedstock, AM system design, AM system
22 software, AM system parameter settings, AM build layout (location and number of parts on the build
23 platform), and the individual parts’ build geometries. In many instances, adequate access to the details
24 of these processing conditions is not available. A thorough, industry-wide understanding of the
25 processing conditions and resulting materials is difficult to achieve but is needed. Because of this,
26 performing enough testing of the finished materials – so that proper statistics can be applied to the test
27 data to ensure a low probability of the actual material properties being less than those guaranteed in a
28 specification – is extremely difficult, and in some cases may be unachievable. In some cases, the ability
29 for a given AM material to achieve minimum mechanical properties may need to be demonstrated for
30 each unique AM system/AM build geometry combination. More information can be obtained in the
31 section on material allowables and design values below.
32 Mechanical properties such as fracture toughness, fatigue strength, and fatigue crack growth are
33 typically not listed as guaranteed minimums in specifications, even those for metals. Instead, typical
34 data are determined and it is the responsibility of the design engineer to add the appropriate safety
35 factors to ensure that the part will have a low probability of failure in service. The more typical data that
36 exists, the more accurate will be the determined probability of failure of the part, so that, in general, the
37 more testing that is done, the better.
1 Thermal properties, including thermal expansion, thermal conductivity and specific heat capacity, of
2 additively manufactured materials are often required for applications. Reliable thermal properties
3 should be available to the end user to allow for an accurate assessment of the thermal conductivity and
4 specific heat capacity of the material after manufacturing. Data are generally available on the powder
5 thermal properties, but limited data are available on the anisotropic nature of thermal properties.
6 Corrosion properties are also a concern. Additional information appears under the Test Methods section
7 below.
8 For the medical device sector, biocompatibility and toxicology are concerns. See section 2.2.2.4.
9 2.2.4.2.1 Specification Content Requirements
10 Public specifications often include numerical values for “minimum” properties; however, the method for
11 determining these numbers is inconsistent across SDOs. Not all specifications include statistically-based
12 minimums. Note: In aerospace, regulators do not generally accept specification minimum properties as
13 meeting requirements for design.
15 SAE AMS recently revised SAE AMS AM Metals General Agreement Data Submission Guidelines
16 (12/3/2022).17 All SAE AMS AM Metal specifications include lot-release minimum mechanical properties
17 based on data analyzed by Battelle Memorial Institute to be compatible with MMPDS, Volume II, Section
18 9.2.2. There is a separate SAE AMS Data Submission Guideline for Non-metal AM specifications. Note:
19 CMH-17 and MMPDS are considered by the FAA, DoD, and NASA as the primary sources for both static
20 allowables and methods for allowables generation for non-metals and metals, respectively, in
21 aerospace.
23 ASTM WK78636 – Additive Manufacturing – General Principles – Standard Practice for Creating Data
24 Sets Used in Metal Additive Manufacturing Standards in ASTM F42.07. The work item as presented in
25 the most recent ballot may produce lot-release minimum values that may be considered inadequate for
26 aerospace users.
27 New Gap FMP7: Material Properties: Specification Content Requirements. Specifications for materials
28 and processes intended for a particular audience need to include minimum material properties that
29 meet that industry’s basic requirements. They also need to consider other requirements such as
30 macro/microstructure for metals, and porosity for polymers. In aerospace, the SAE AMS AM data
31 submission requirements are aligned with the primary material allowable references (CMH-17 and
32 MMPDS) to ensure that material submitted to those programs support aerospace regulations and
17
These Guidelines are available to AMS-AM committee members in conjunction with developing SAE standards.
1 requirements. At least within an industry, specification content requirements would simplify the
2 material selection process knowing that the framework for specification development is consistent and
3 the output from different specifications are comparable.
5 R&D Expectations: Review existing data generation and analysis methods and document appropriate
6 standard practices at an industry level for minimum material properties, and for microstructure. This
7 could include a literature survey to review the approaches across different industries. R&D is needed to
8 establish what test should be done as a lot release in AM. (Machined ASTM E8 bars are not sensitive to
9 many LPBF specific processes failures.)
10 Recommendation: Coordinate activity between SDOs, including the AM data generation and/or data
11 management consortia groups SAE-ITC Additive Manufacturing Data Consortium (AMDC) and ASTM
12 Consortium for Materials Data Standardization (CMDS), so that specifications for specific industries
13 produce comparable content. Each industry may need to have its own standard. The aerospace industry
14 generally complies with CMH-17 and MMPDS.
16 Organization(s): ASTM International, SAE AMS, CMH-17, MMPDS for aerospace, defense, and space.
17 Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☒Finished

19 Repair; ☒Data


27 Current Alternative: Each user must verify that a public specification meets the requirements of
28 cognizant regulators. This can be cost prohibitive, restricting the opportunities for use of AM.
30 New
1 2.2.4.2.2 Metals
2 Defining a set of minimum properties for AM products is difficult because properties are dependent on
3 the process, the process parameters, the direction of the test sample relative to the build direction, the
4 location on the build plate, the type of machine used for the build, the geometry, the post-AM thermal
5 processes, and the operator, among other factors. Since the relationship between these variables and
6 properties is not currently well known, and since the method of qualifying minimum properties may be
7 application dependent, developing a well-supported set of minimum properties is a challenge.
8 Standards that contain minimum properties for AM parts are primarily for specific metals produced by
9 laser powder bed fusion and directed energy deposition. These do so by leaving the method of
10 qualification up to an agreement between the purchaser and the supplier. Many other factors, not all of
11 which are currently known or understood, can interact in a way that creates highly complex processing
12 conditions. To get test data that are valid for a given process, all process parameters must be fixed
13 under controlled conditions, including post-build treatments. The resultant data are then only useful for
14 that specific process. Standardizing an optimized process therefore significantly lowers the amount of
15 testing required to determine guaranteed mechanical properties, but this standardization is likely to be
16 machine-specific, at least in the near future. Any major change to the fixed process requires the
17 substantiation that the critical mechanical properties do not detrimentally change. See the section
18 below on material allowables and design values.
19 Published Standards (Metals)
20 There are several specifications for metal AM materials that cover the manufacturing process and state
21 minimum properties of specific materials produced primarily by powder bed fusion, with standards for
22 other processes beginning to emerge. In many cases, these properties are currently derived from metal
23 casting properties.
24 ASTM F42

33  ASTM F3184-16, Standard Specification for Additive Manufacturing Stainless Steel Alloy (UNS
34 S31603) with Powder Bed Fusion
35  ASTM F3302-18 Standard for Additive Manufacturing – Finished Part Properties – Standard
36 Specification for Titanium Alloys via Powder Bed Fusion
1  ASTM F3318-18 Standard for Additive Manufacturing – Finished Part Properties – Specification
2 for AlSi10Mg with Powder Bed Fusion – Laser Beam
3 ASTM F42/ISO TC 261
4  ISO/ASTM 52909:2022, Additive manufacturing of metals — Finished part properties —

5 Orientation and location dependence of mechanical properties for metal powder bed fusion
6
7 SAE AMS-AM
8  SAE AMS4999A, Titanium Alloy Direct Deposited Products 6Al - 4V Annealed (2016-09-26)
14  SAE AMS7011, Electron Beam-Powder Bed Fusion (EB-PBF) Produced Preforms and Parts,
15 Titanium Alloy, 6Al - 4V, Hot Isostatically Pressed (2022-11-22)
16
17 In Development Standards (Metals)
18 There are several new standards under development that discuss minimum properties for metal AM
19 parts of specific materials produced by powder bed fusion or other processes as listed below, although
20 they may not state exactly how to determine these properties.
21 ASTM F42
22  ASTM WK65929, Specification for Additive Manufacturing-Finished Part Properties and Post
23 Processing - Additively Manufactured Spaceflight Hardware by Laser Beam Powder Bed Fusion
24 In Metals
27  ASTM WK66637, Specification for Additive Manufacturing -- Finished Part Properties --
28 Specification for 4340 Steel via Laser Beam Powder Bed Fusion for Transportation and Heavy
29 Equipment Industries
30  ASTM WK77186, New Specification for Additive Manufacturing -- Finished Part Properties
31 -- Specification for Niobium-Hafnium Alloy UNS R04295 via Laser Beam Powder Bed
32 Fusion for Spaceflight Applications
33  ASTM WK78636, New Practice for Additive Manufacturing -- General Principles -- Standard
34 Practice for Creating Data Sets Used in Metal Additive Manufacturing Standards
35  ASTM WK82659, New Specification for Additive manufacturing -- Powder bed fusion -- Standard
36 specification for maraging steel (UNS K93120)
1
2 ASTM F42/ISO TC261
3  ISO/ASTM DIS 52924, Additive manufacturing of polymers — Feedstock materials —

4 Qualification of materials for laser-based powder bed fusion of part
5
6 SAE AMS-AM
7  SAE AMS7009, Additive Manufacturing of Titanium 6Al4V with Laser-Wire Deposition - Annealed
8 and Aged (2018-01-06)
9  SAE AMS7016, Laser-Powder Bed Fusion (L-PBF) Produced Parts, 17-4PH H1025 Alloy (2018-10-
10 24)
11  SAE AMS7024, Inconel 718 L-PBF Material specification (2019-06-19)
13 Relieved, and Hot Isostatic Pressed (2020-01-31)
14  SAE AMS7030, Laser- Powder Bed Fusion (L-PBF) Produced Parts of AlSi10Mg (2020-02-19)
16 Resistant 17Cr – 13Ni – 2.5Mo (316L), Hot Isostatic Pressed (2021-03-09)
19 Isostatic Pressed (2021-03-02)
21 Resistant 17Cr – 13Ni – 2.5Mo (316L), Stress Relief and Anneal (2021-04-19)
22  SAE AMS7046, Laser Powder Bed Fusion Produced Parts, Aluminum Alloy, 5.3Zn – 3.3Mg - 1.7Zr
23 – 1.6Cu (Composition Similar to 7A77.60), SR + HIP + T7 (2022-01-14)
24  SAE AMS7047, Low Alloy, Medium Carbon Steel Powder for Binder Jet Additive Manufacturing,
25 1.0Cr – 0.20Mo – 0.30C (Composition Similar to UNS G41300) (2022-01-14)
27 – 0.30C, As-Sintered (Composition Similar to UNS G41300) (2022-01-14)
29 – 0.30C, Austenitized, Quenched and Tempered (Composition Similar to UNS G41300) (2022-01-
30 14)
32 – 0.30C, Hot Isostatic Pressed, Austenitized, Quenched and Tempered (Composition Similar to
33 UNS G41300) (2022-01-14)
34  SAE AMS7051, Binder Jet (BJAM) Printed Parts, Precipitation Hardenable Steel Alloy, Corrosion
35 and Heat-Resistant, 16.0Cr - 4.0Ni - 4.0Cu - 0.30Nb Solution Annealed and H900 Aged (2022-06-
36 20)
37  SAE AMS7051/1, Binder Jet (BJAM) Printed Parts, Precipitation Hardenable Steel Alloy, 16.0Cr -
38 4.0Ni - 4.0Cu - 0.30Nb Solution Annealed and H900 Aged, Desktop Metal – Production System P-
39 1 (2022-06-20)
40
1 Gap FMP1: Material Properties (Metals). Standards that address thermal properties, minimum
2 mechanical properties, and degradation properties, and that also contain qualification procedures, are
3 needed for metallic AM materials. Many metals used in aerospace applications have standardized tables
4 in MMPDS, Volume II.
6 R&D Expectations: Developing these standards will require generating data that currently may not exist
7 or may not be in the public arena. The ASTM AM CoE Strategic Roadmap for Research & Development
8 (April 2020) notes that AM CoE has several projects aimed at addressing this gap. A material
9 specification, ASTM WK82659 for maraging steel, is under development in F42.05 and through an AM
10 CoE project 2006.
11 Recommendation: Develop standards that identify the means to establish material properties and
12 qualification procedures for metals made using a given AM process, set of parameters, and build design.
13 Qualification requirements to establish minimum mechanical properties for AM parts need to be
14 developed.
16 Organization: ASTM F42/ISO TC 261, SAE AMS-AM, MMPDS, NIST, ASME, ASTM AM CoE
17 Lifecycle Area: ☐Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☒Finished

19 Repair; ☐Data


29 New
30 V3 Update: ASME research project 0183 has been completed, and shows statistical correlations of some
31 critical properties and property interactions with respect to the essential variables of ASME code case
32 3020. (ASME code case 3020 provides assumptions of which base metal can be compared to get other
1 properties that weren’t tested.) Round robin testing by multiple parties is ongoing. Results from ORNL
2 have been received and the data needs to be incorporated into a report.
3
4 The National Center for Advanced Materials Performance (NCAMP) and Joint Metals Additive Database
5 Definition (JMADD) qualification program funded by America Makes and FAA, led by Wichita State
6 University National Institute for Aviation Research (NIAR) is working to develop material property data
7 for Ti-6-4 on laser powder bed fusion process. The program started in early 2021.
8 2.2.4.2.3 Non-Metals
9 Published Standards (Non-Metals)
10 SAE AMS-AM
11  SAE AMS7100/1, Fused Filament Fabrication Process - Stratasys Fortus 900mc Plus with Type 1,
12 Class 1, Form 1, Grade 0 Natural Color Material for (2022-07-06)
13  SAE AMS7101/1, Fused Filament Fabrication, Type 1, Class 1, Form 1, Grade 0, Natural Color
14 Material for (2022-07-06)
15  SAE AMS7101A, Fused Filament Fabrication, Material for (2022-07-08)
16
17 In Development Standards (Non-Metals)
18 ASME
19  ASME is working to form a Working Group on this topic for polymers.

20
21 SAE AMS-AM
22  SAE AMS7100/1A, Fused Filament Fabrication Process - Stratasys Fortus 900mc Plus, with Type
23 1, Class 1, Form 1, Grade 0, Natural Color Material for (2022-10-04)
24  SAE AMS7100/3, Fused Filament Fabrication Process – Stratasys F900 with Type 3, Class 1, Form
25 3, Grade 3CNT, Black Color Material for (2022-07-11)
26  SAE AMS7100/4, Fused Filament Fabrication Process – Stratasys F900 with Type 3, Class 1, Form
27 3, Grade 0, Natural Color Material for (2022-07-11)
28  SAE AMS7101/2, 1Fused Filament Fabrication Process- Markforged X7 with Onyx FR-A a Type 1
29 Form 1 PACF15FR15 filament (2021-10-21)
30  SAE AMS7101/3, Fused Filament Fabrication, Type 3, Class 1, Form 3, Grade 3CNT, Black Color
31 Material for (2022-07-11)
32  SAE AMS7101/4, Fused Filament Fabrication, Type 3, Class 1, Form 3, Grade 0, Natural Color
33 Material for (2022-07-11)
34  SAE AMS7101B, Fused Filament Fabrication, Material for (2022-07-11)
35  SAE AMS7103, Material for High Performance Laser Sintering (2019-01-15)
36  SAE AMS7104, Continuous Fiber Reinforced Fused Filament Fabrication
1  SAE AMS7104/1, Continuous Fiber Reinforced Fused Filament Fabrication Markforged
2  SAE AMS7105, Continuous Carbon Fiber Reinforced Fused Filament Fabrication - Markforged
3  SAE AMS7105/1,Continuous Carbon Fiber Reinforced Fused Filament Fabrication, material
4 Carbon Fiber FR-A
5
6 New Gap FMP8: Material Properties (Non-Metals). Standards that address thermal properties,
7 minimum mechanical properties, and degradation properties, and that also contain qualification
8 procedures, are needed for non-metallic AM materials. Non-metals are addressed in CMH-17 Volume
9 VII.
12 or may not be in the public arena.
13 Recommendation: Develop standards that identify the means to establish material properties and
14 qualification procedures for non-metals made using a given AM process, set of parameters, and build
15 design. Qualification requirements to establish minimum mechanical properties for AM parts need to be
16 developed.
17 Priority: ☒High; ☐Medium; ☐Low (Polymers) / ☐High; ☐Medium; ☒Low (Ceramics)
18 Organization: ASTM F42/ISO TC 261, SAE AMS-AM, CMH-17, NIST, ASME

21 Repair; ☐Data

24 Material Type: ☐All/Material Agnostic; ☐Metal; ☒Polymer; ☒Ceramic; ☒Composite

31 New
1 V3 Update: The NCAMP Polymer AM qualification program includes HexPEKK and Markforged
2 continuous fiber composite material. Both programs started in 2020. NCAMP released public
3 specifications and a material property database of ULTEM 9085/Fortus 900MC in 2018.
4 The CMH-17 Non-Metallic Additive Manufacturing Coordination Group was formed in October 2018. A
5 CMH-17 committee is drafting tables of material properties to be included in the first release of the non-
6 metallic handbook. Properties are based on NCAMP qualification of ULTEM 9085.
7 2.2.4.2.4 Test Methods (Metals and Non-Metals)
8 There is currently a need for standards on mechanical property test methods that are specific for AM
9 parts.
11 There is currently a guide for determining the types of existing mechanical tests that should be used for
12 evaluating mechanical properties of AM materials (ASTM F3122-14(2022), and a standard on how to
13 report data (ASTM F2971-13(2021). MMPDS (metals) and CMH17 (non-metals) include a listing of
14 thermal and mechanical tests.
16 AMPP
17 AMPP TR21522, Corrosion Testing for Additive Manufacturing, was formed in July 2021 with the goal of
18 assessing the state of the art with respect to corrosion testing of additive manufactured materials and
19 preparing a summary report with recommendations. A group of about 35 subject matter experts were
20 assembled to accomplish the goals. An assessment of the open literature resulted in the selection of
21 about 340 relevant references that were evaluated with respect to corrosion mechanism, material and
22 additive manufacturing process.
23 The corrosion mechanisms investigated included general and localized corrosion, environmental
24 cracking (such as SCC, SSC and HISC) and high temperature oxidation. The scope was limited to metallic
25 materials of construction.
26 As of November 2022, the assessment of the open literature is complete and the compilation of the
27 gems gleaned from the literature is largely complete. TR21522 has started drafting the report with
28 Scope and Introduction sections completed. The timeline for completion of the report and submittal for
29 peer review has recently been updates and has been set to April 2023.
30 ASTM F42
31  ASTM WK66029, Guide for Mechanical Testing of Polymer Additively Manufactured Materials
1  ASTM WK70164, Practice for Additive Manufacturing -- Finished Part Properties -- Standard
2 Practice for Assigning Part Classifications for Metallic Materials
3  ASTM WK71391, Guide for Additive Manufacturing -- Static Properties for Polymer AM
4 (Continuation)
7  ASTM WK73340, Test Method for Additive Manufacturing – Dynamic Properties of Polymer
9  ASTM WK75901 Test Method for Additive Manufacturing -- Test Artifacts -- Miniature Tension
10 Testing of Metallic Materials
11  ASTM WK78224, Test Method for Additive Manufacturing -- Vat Photopolymerization -- Next
12 Generation Tensile Test Method
13
14 MPIF
15 The Metal Powder Industries Federation (MPIF) is working on material standards MPIF Std 35 for Metal
16 AM Components. MPIF has completed tensile testing for SS-316L and 17-4PH annealed condition from
17 binder jet and LPBF processes. MPIF has out for testing 17-4PH H900 for both processes. Upon
18 completion of the 17-4PH H900 testing a standard will be issued (Spring 2023). Samples are tested per
19 MPIF Test Std 74 or 75 and samples are from 3 to 6 commercial process vendors. Data will include
20 tension min and typ., properties, typ. hardness, typ. density and chemistry limits. MPIF Test Stds 74 and
21 75 describe the exact geometry and method of producing the tension bars.
22 New Gap FMP9: Material Properties: Test Methods (Metals and Non-Metals). Existing mechanical test
23 methods for traditionally-manufactured parts are used as needed for AM, and are acceptable for many
24 purposes. Unique testing standards that take into consideration characteristics that are unique to AM
25 parts such as those that use multiple materials (i.e., heterogenous/nonhomogeneous), gradients in
26 composition and/or microstructure, and anisotropy are needed.
29 or may not be in the public arena.
30 Recommendation: Develop standards on mechanical property test methods that are specific for AM
31 parts
32 Priority: ☒High; ☐Medium; ☐Low (Metals, Polymers) / ☐High; ☐Medium; ☒Low (Ceramics)
33 Organization: ASTM F42/ISO TC 261, SAE AMS-AM, CMH-17, MMPDS, NIST, ASME, AMPP, MPIF
3 Repair; ☐Data


13 New
14 2.2.4.3 Component Testing
15 Introduction
16 Component testing using currently available test methods needs to consider the problem with building
17 standard coupon geometries that are then machined to dimensions. Any post-processing or machining
18 of the key areas could influence the results of mechanical testing (for example, machining (?) all the
19 material processed with contour parameters) and as a result may not be representative of a part that is
20 put into service in the as-built condition or only lightly finished.
21 Additive Part Qualification: Aerospace Perspective
22 Once form and fit have been established, the end user of an AM component must validate the
23 systematic functionality of the AM component. In addition to basic, foundational knowledge about
24 fundamental material properties and production processing effects, reasonable component level
25 destructive tests and nondestructive testing methods performed by ISO/IEC 17025 accredited testing
26 laboratories should be used to qualify the AM component function.
27 Examples of component-level destructive tests could include: part cut-ups to validate dimensional and
28 critical material morphology, static or fatigue/damage tolerance strength evaluations from a configured
29 part, lug or crippling strength/stability evaluations, etc. Non-destructive examples could include X-
30 ray/computed tomography, pressure, eddy current, etc.
1 Note that these non-destructive functionality tests may evolve into a statistically-based plan for ongoing
2 validation of AM part quality in production.
3 Additive Part Qualification: Medical Device Perspective
4 Mechanical properties testing for components and coupons is integral to the qualification and approval
5 process. For any given part, different aspects may be critical to its function. In the medical field, AM
6 devices can be used to match a patient’s anatomy or create an implant that would otherwise be
7 impossible to manufacture. Some applications require long fatigue life and strength as the primary
8 mechanical properties (e.g., a hip implant). Others require flexibility, and the ability to degrade over
9 time in a way that maintains geometric stability (e.g., a tracheal splint).
10 In medicine, the diversity of applications and complexity of geometric shapes means there are many
11 different aspects that may be tested for any given part. It is often difficult to determine what can be
12 tested with coupons and what must be tested on the part. In addition, the quality of the part can be
13 strongly influenced by the other parts in the build volume or positioning of parts in the space, meaning
14 that careful coupon planning is imperative. Clear guidelines are not yet available for these aspects of
15 coupon use in AM for the medical field; however, some general guidelines do exist.
17 Guidelines for validation methods for manufacturing methods are available from the FDA through the
18 Quality System regulations and current Good Manufacturing Practices documentation. Other industries
19 have similar practices. These sets of documents provide a framework to help manufacturers establish
20 internal methods for verifying a production process, determining the appropriate quality controls, and
21 validating it to reduce testing burden over time.
22 In terms of published standards, the requirements for testing and validation are described in FDA's
23 Design Control Guidance for Medical Device Manufacturers (relates to FDA 21 CFR 820.30 and Sub-
24 clause 4.4 of ISO 9001) and also in ISO 13485. Other published standards include ASTM F3127-22,
25 Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices.
26 General testing standards can also be applied.
27 2.2.4.4 Biocompatibility of Medical AM Parts
28 It is generally thought that biocompatibility standards such as ANSI/AAMI/ISO 10993-1:2018 have

29 already been developed to address a broad range of materials and therefore should still be sufficient to
30 assess the biocompatibility of AM materials. Biocompatibility is done on a final, finished, sterilized
31 device. The final finished device is extracted in polar, mid-polar and non-polar solvents and substances
32 identified by analytical tests and the biocompatibility of these substances determined through testing in
33 biocompatibility assays. Depending on the patient contact site and duration of exposure to a device, it
34 might also be necessary to conduct animal testing for biocompatibility.
35 Published Standards and Guidance
1  ANSI/AAMI/ISO 14971:2019, Medical devices – Application of risk management to medical
2 devices
3  ANSI/AAMI/ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And
4 Testing Within A Risk Management Process
5 o Use of International Standard ISO 10933-1, "Biological evaluation of medical devices – Part
6 1: Evaluation and testing within a risk management process," Guidance for Industry and
7 Food and Drug Administration Staff (September 2020)
8  ISO 10993-18:2020, Biological evaluation of medical devices – Part 18: Chemical characterization
9 of medical device materials within a risk management process
10  ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
11 applications — Part 1: Evaluation and testing within a risk management process
12  ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
13 applications — Part 4: Tests for leachables in condensate
14
15 No gaps have been identified with respect to biocompatibility.
16 2.2.4.5 Removal of AM Feedstock from Medical AM Parts
17 It can be very difficult to clean parts of remaining raw AM material. Cleaning protocols can vary
18 significantly between AM technologies and between manufacturers because of the wide range of
19 materials and applications combinations that are possible. Several nondestructive measurement
20 techniques such as computed tomography (CT) or ultrasound scans are already being adopted by part
21 producers. A potentially small number of measurement and evaluation techniques could likely assess a
22 large proportion of AM parts.
24  ASTM F3127-22, Standard Guide for Validating Cleaning Processes Used During the Manufacture
25 of Medical Devices
26  ASTM F3208-20, Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for
27 Reusable Medical Devices
28  ASTM F3275-22, Standard Guide for Using a Force Tester to Evaluate Performance of a Brush
29 Part Designed to Clean the Internal Channel of a Medical Device
30  ASTM F3335-20, Standard Guide for Assessing the Removal of Additive Manufacturing Residues
31 in Medical Devices Fabricated by Powder Bed Fusion
32  ISO 19227:2018, Implants for Surgery - Cleanliness of Orthopedic Implants- General
33 Requirements
34  ISO/TS 19930:2017, Guidance on Aspects of a Risk-Based Approach to Assuring Sterility of
35 Terminally Sterilized, Single-Use Health Care Product That Is Unable to Withstand Processing to
36 Achieve Maximally A Sterility Assurance Level Of 10-6
37  United States Pharmacopeia-National Formulary (USP-NF), General Chapter 788 Revision,
38 Particulate Matter in Injections
1
3  ASTM WK82776 - Additive Manufacturing for Medical - PBF - Assessment of Residual Powder
4
5 Gap FMP3: Removal of AM Feedstock from Medical AM Parts. Like many medical devices, medical AM
6 parts must be cleaned of manufacturing residues and contact materials prior to packaging or final use.
7 The cleaning process should ensure that AM materials such as powder are removed before use. Residual
8 AM feedstock left on the parts may include but is not limited to cooling fluids or AM materials (powder
9 or uncured monomer), that may be stuck within small geometric features or lattice structures. There is a
10 need to reproducibly measure and evaluate the residual AM feedstock of a part with relevant, risk-
11 based acceptance criteria.
13 R&D Expectations: R&D is needed to establish standards which discern clean from uncleaned parts in
14 terms of AM residual feedstock; specifically, to reliably distinguish unsintered, unmelted, and uncured
15 material from the intended part.
16 Recommendation: Develop standard test methods, metrics, and acceptance criteria for measuring
17 cleanliness of complex 3D geometries that are based on existing standards but focus on AM-specific
18 considerations. ASTM F42 already has work in progress.
20 Organization: AAMI, ASTM F04, ASTM F42/ISO TC 261, ISO/TC 150, ISO/TC 194, ISO/TC 198

23 Repair; ☐Data


2 ☐New
3 V3 Update: A number of ASTM F04.15 (material test methods) standards have been updated.
4
5 2.2.4.6 Chemistry
6 Introduction
7 Chemistry of materials (i.e., chemical composition) is the foundation that drives material performance
8 such as mechanical properties and corrosion resistance. Ensuring the proper chemical composition of
9 materials throughout the manufacturing process is essential in the certification of products used in
10 industry. It is essential for product specifications to contain rigorous chemistry requirements as well as
11 standard chemical analysis test methods to ensure that delivered product meets the intended design
12 requirements. Most additive manufacturing processes rapidly melt and solidify materials, thus having
13 the ability to lead to unusual behavior in some material systems compared to traditional manufacturing
14 methods. Some unusual behavior has been noted in changes from pre-build chemistry to post-build
15 chemistry. Therefore, it is essential for additive manufacturing standards to contain chemistry
16 requirements and standard chemical analysis test methods for both feedstock (precursor) materials and
17 as-built parts (finished materials).
19 There are several specifications for metal AM parts fabricated using powder bed fusion that have
20 requirements for chemical composition of the as-built part. Generally, these specifications require both
21 the feedstock (precursor) material and the as-built part to meet required chemical composition
22 requirements defined in the specification.
23 There are currently well-established standards for chemical analysis test methods for metal materials
24 (examples include ASTM E34, E353, etc.).
25 Existing Specifications Including Chemical Composition Requirements for AM Parts

ASTM F42 F2924- Standard Specification for Additive Manufacturing Titanium-6
14(2021) Aluminum-4 Vanadium with Powder Bed Fusion
F3001- Standard Specification for Additive Manufacturing Titanium-6
14(2021) Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed
Fusion
F3055- Standard Specification for Additive Manufacturing Nickel Alloy (UNS
14a(2021) N07718) with Powder Bed Fusion
F3056- Standard Specification for Additive Manufacturing Nickel Alloy (UNS
14e1(2021) N06625) with Powder Bed Fusion
F3184-16 Standard Specification for Additive Manufacturing Stainless Steel
Alloy (UNS S31603) with Powder Bed Fusion
F3213-17 Standard for Additive Manufacturing – Finished Part Properties –
Standard Specification for Cobalt-28 Chromium-6 Molybdenum via
Powder Bed Fusion
F3318-18 Standard for Additive Manufacturing – Finished Part Properties –
Specification for AlSi10Mg with Powder Bed Fusion – Laser Beam
SAE AMS-AM AMS7000A Laser-Powder Bed Fusion (L-PBF) Produced Parts, Nickel Alloy,
Corrosion and Heat-Resistant, 62Ni – 21.5Cr – 9.0Mo – 3.65 Nb
Stress Relieved, Hot Isostatic Pressed and Solution Annealed (2022-
05-16)
AMS7004 Titanium Alloy Preforms from Plasma Arc Directed Energy Deposition
Additive Manufacturing on Substrate, Ti-6Al-4V, Stress Relieved
(2019-01-31)
AMS7011 Electron Beam-Powder Bed Fusion (EB-PBF) Produced Preforms and
Parts Titanium Alloy, 6Al - 4V Hot Isostatically Pressed (2022-11-22)
1
3 Specifications in Development Including Chemical Composition Requirements for AM Parts
Work Item
Committee Title
Number
SAE AMS-AM AMS7009 Additive Manufacturing of Titanium 6Al4V with Laser-Wire
Deposition - Annealed and Aged
4
5 While no gaps have been identified, SDOs (e.g., ASTM, SAE, etc.) should continue to include chemical
6 composition requirements in AM part (finished materials) specifications. Standards also should continue
7 to require both the feedstock (precursor) material and as-built part (finished material) to conform to
8 their specific chemistry requirements unless otherwise determined necessary.
9 2.2.4.7 Material Allowables
10 Material allowables are statistically derived static material properties based on a defined set of data and
11 statistical analysis methods. Users must apply appropriate influence factors to material allowables in
12 order to compute design values that are accepted by government procuring and/or certification
13 agencies for the development and manufacture of aerospace products. Design values, although critical
14 for certification, are typically highly proprietary and application dependent and therefore are not
15 expected to be published in standards. Public standards may identify some possible influence factors to
16 consider, but they will not include any design values. For the widespread adoption of AM for the
17 aerospace industry, reliable material allowables must be developed which can be used by industry to
18 compute design values that may be considered for acceptance by the various procuring and certification
19 agencies.
1 The development of standard test methods, specifications, and best practice guides will allow for the
2 standardization of additively manufactured materials property data that can be used to generate
3 material allowables, which are needed for computing design values for acceptance by government
4 procuring and certification agencies. The data obtained through these standards and specifications can
5 be used for statistical analysis of material allowables (typically T90 or T99 values). Once these material
6 allowables are established, the application of AM components can be accelerated.
7 For metals, MMPDS has approved data generation and analysis procedures for calculating material
8 allowables that may be adopted for metallic additive manufacturing. See section 2.3.2.4 in the Q&C
9 chapter for more details on MMPDS.
10 For polymers, CMH-17 has approved data generation and analysis procedures for calculating material
11 allowables that may be adopted for non-metallic additive manufacturing. The user remains responsible
12 for determining influence factors that satisfy their customer. See section 2.3.2.4 in the Q&C chapter for
13 more details on CMH-17.
14 Although several material specifications have been published for use with AM materials, they are not
15 sufficient enough in detail to support the development of material allowables. The minimum mechanical
16 properties values may not always be statistically derived and, therefore, cannot be used to develop S-
17 basis, T90, and T99 values. In many cases, these properties are currently derived from metal casting
18 properties.
19 The standard terminology, practices, and guides may be of some use in developing a standard method
20 to describe various AM processes and testing methods.
21 An alternative to the allowables approach for additive processes is documented in the NASA standard
22 NASA-STD-6030. Rather than a one-time, comprehensive allowables development campaign that
23 attempts to account for all future variability in one large sampling, the method of NASA-STD-6030
24 requires a lower initial investment that is bolstered by continuous statistical process control. For
25 additive manufactured materials there is heightened concern for future variability that may not be
26 captured in the one-time sampling effort of the traditional methodology. Ongoing quality and
27 performance evaluations are required on a build-to-build basis to maintain material consistency
28 (equivalence from an engineering perspective), which includes periodic review and confirmation that
29 newly produced materials continue to perform equivalent to the materials originally used to develop the
30 properties. As documented in the standards, this methodology is unique as it involves sustained
31 engagement and interaction of engineering and production to monitor the process and confirm that
32 controls are adequate for produced parts to meet the design value assumptions.
33 In applications using ASME boiler and pressure vessel code (B&PVC) as a basis, the addition of AM
34 materials into the stress and physical properties tables in ASME Section II Part D represents the most
35 direct path to widespread adoption of AM materials in B&PVC applications. In order to add AM
36 materials to the data tables, test data of representative additively manufactured parts must be
37 correlated to the material properties and allowables in ASME Section II, Part D to determine
1 applicability; and if not applicable, new data must be generated for addition to the Part D tables. While
2 other adoption methods may be necessary due to process variability, this effort would likely be
3 undertaken during establishment of ASTM material specifications as part of a larger adoption effort of
4 ASTM additive material specifications into ASME Section II.
5 Gap FMP4: Material Allowables. Several material and process specifications are now available for use in
6 material allowables programs. In addition, there are multiple public allowables development programs
7 in progress. For metallic additively manufactured material, the MMPDS General Coordination
8 Committee has approved guidelines, definitions, specification content, data generation, data analysis,
9 and presentation guidelines for users. MMPDS continues to work toward compiling the first edition of
10 MMPDS, Volume II. The target release is tentatively forecasted to be July 1, 2024. An MMPDS Agenda
11 Item, 11-40 Guidelines for Emerging Materials and Technologies, included potential procedures to
12 publish material allowables in a handbook and illuminated the gaps that would need to be addressed
13 before AM could be included. For polymer based additively manufactured materials, an FAA sponsored
14 research program developed allowables that are currently under consideration for a future publication
15 of CMH-17.
17 R&D Expectations: Recommended R&D required to fill this gap includes expansion of current allowables
18 activities and further guidelines to support these activities.
19 Recommendation: Leverage research to improve existing guidelines as follows:
20 - Expand on allowable programs in progress

21 - Develop additional guidelines for best practices
22 - Expand allowables programs with additional AM processes and alloys
23 - Additional machine types for a given alloy
24 - Statistical methodology assessment and validation
25 - Acceptance and equivalency protocol development and validation
26
28 Organization: ASTM F42/ISO TC 261, SAE AMS-AM, AWS, NASA, ASME BPVC, MMPDS, CMH-17, NIST

31 Repair; ☒Data


5 Current Alternative: Proprietary methods are being used in lieu of industry standards.
7 ☐New
8 V3 Update: As described in the text.
9 2.2.4.8 Microstructure
10 Microstructure is a multiscale subsurface structure of a metallic alloy that can be viewed by either
11 surface treatments that reveal the subsurface structures (e.g., etching) or by recording the subsurface
12 response to external stimuli (e.g., electron beam, X-ray, etc.).
13 For metallic alloys, subsurface structures include phase-based features (e.g., laths, grains, etc.) and
14 defects (e.g., cracks, porosities). Both identification and quantification of various microstructure
15 features are needed to link them with the additively manufactured part’s performance. For phase-based
16 features, both morphology and crystallography of various phases need to be identified and quantified;
17 these are dependent on the alloy system and the thermomechanical pedigree. Defects morphology,
18 which is dependent on processing pedigree, also needs to be identified and quantified. Due to the
19 heterogeneous nature of the AM process, microstructure quantifications should account for the 3D
20 spatial variability of various microstructure features that often results in 3D spatial heterogeneity in
21 material properties.
22 Microstructure has a direct impact on an AM part’s performance because it affects its location specific
23 material properties under static and dynamic loading conditions. Thus, understanding the
24 microstructure characteristics (spatial variability of crystallography and morphology) leads to accurate
25 estimates of the part’s in-service performance and further optimization of post-processing heat
26 treatments to control the location of specific material properties and, hence, the part’s in-service
27 performance.
28 For metallic alloys to be included in MMPDS, micrographs and other relevant data and metadata will be
29 required. Some of that information will be available to users to support regulatory reviews. Industry and
30 government experts are evaluating options for this new approach to commodity material acceptance.
31 Specification content requirements for AM require that the SDO and specification sponsor consider
32 what microstructure controls are needed for a particular alloy. Users can impose application specific
33 requirements above and beyond what is included in the specification of MMPDS.
34 Test Methods or Best Practice Guides for Microstructure of AM Parts
1 The nature of vertically building parts in AM causes directionality in the thermal gradient that is
2 complicated by the variability in a part’s geometry and the resultant heterogeneous microstructure that
3 is characterized by 3D spatial variability. Thus, microstructure identification and quantification in AM
4 should consider microstructure heterogeneity as the norm and homogeneity as the special case. Fast
5 cooling rates from the melt combined with thermal gradients can result in submicron scale
6 microstructure features (e.g., martensite needles or alpha laths in alpha/beta titanium) within
7 millimeter scale features (e.g., prior beta grains in titanium alloys or large gamma grains in TiAl). Thus,
8 microstructure identification and quantification methods should account for multiscale 3D
9 microstructure spatial heterogeneities that span to tens of millimeters while having the resolution of
10 sub-micrometers. While the physics of traditional casting and welding processes are different than the
11 one associated with metallic additive manufacturing, established standards for microstructure
12 identification and quantification in both techniques can be used as a start towards standards for AM.
13 However, they often focus on the morphology of phases with limited standards for crystallography and
14 no standards for spatial distribution.
16 The following test standards are published for microstructure morphology quantification:
Committee Test Standard Title Notes

Number
ASTM ASTM A247-19 Standard Test Method for This can be a guide to image
Subcommittee: Evaluating the Microstructure based evaluation of
A04.21 of Graphite in Iron Castings microstructures due to the
similarity in heterogeneity of
graphite in iron to various
phases of heterogeneities in
AM alloys
ASTM ASTM E3- Standard Guide for Preparation
Subcommittee: 11(2017) of Metallographic Specimens
E04.01
ASTM ASTM E407- Standard Practice for The procedures in this
Subcommittee: 07(2015)e1 Microetching Metals and Alloys standard can be followed for
E04.01 inspecting AM metals
ASTM - ASTM E112- Standard Test Methods for Does not account for
Subcommittee: 13(2021) Determining Average Grain heterogeneous
E04.08 Size microstructure
ASTM - ASTM E930-19 Standard Test Methods for Does not account for spatial
Subcommittee: Estimating the Largest Grain location of ALA grain and the
E04.08 Observed in a Metallographic alignment relative to the build
Section (ALA Grain Size) direction
ASTM - ASTM E1181- Standard Test Methods for It may partially work for TiAl
Subcommittee: 02(2015) Characterizing Duplex Grain alloys but not for the gradient
E04.08 Sizes from surface to core of AM
parts
Committee Test Standard Title Notes
Number
ASTM - ASTM E2627- Standard Practice for Not suitable for AM grain
Subcommittee: 13(2019) Determining Average Grain structure
E04.11 Size Using Electron Backscatter
Diffraction (EBSD) in Fully
Recrystallized Polycrystalline
Materials
ASTM - ASTM E562-19 Standard Test Method for Partial use in AM because
Subcommittee: Determining Volume Fraction volume fraction is not enough
E04.14 by Systematic Manual Point
Count
ASTM ASTM E1268- 19 Standard Practice for Assessing Not suitable for AM. While
Subcommittee: the Degree of Banding or banding is a sort of
E04.14 Orientation of Microstructures heterogeneity, in AM there is
size heterogeneity in addition
to orientation banding
ASTM - ASTM E1382- Standard Test Methods for An average is not suitable for
Subcommittee: 97(2015) Determining Average Grain AM
E04.14 Size Using Semiautomatic and
Automatic Image Analysis
ISO/TC 202 ISO 13067:2020 Microbeam analysis - Electron It does not address the size of
backscatter diffraction - EBSD scan to have reliable
Measurement of average grain statistics of grains in AM
size material
1
4 Processing - Additively Manufactured Spaceflight Hardware by Laser Beam Powder Bed Fusion in
5 Metals
8 Gap FMP5: Microstructure. There is an inherent heterogeneity in the microstructure of metallic alloys
9 made by AM that requires a standard for identification and quantification of the spatial variability of
10 various microstructure features.
12 R&D Expectations: Develop Calphad databases suitable for non-equilibrium solidification. ASTM AM CoE
13 Strategic Roadmap for Research & Development (April 2020) notes that AM CoE Projects 1804/1907
14 (WK65937, WK65929) address AMSC gap FMP5.
15 Recommendation: Develop a standard for characterization and acceptance criteria of AM

16 microstructures (both identification and quantification).
2 Organization: NIST, ASTM

5 Repair; ☐Data
6 Sectors: ☐All/Sector Agnostic; ☒Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☐Electronics;


15 ☐New

17
18 2.2.4.9 AM Defect Structures
19 All manufacturing processes invariably produce some level of defect structures. Some of the defect
20 types are unique to additive and not observed in traditional materials processing. Defects are in general
21 discontinuities in the material and can negatively influence the performance that is offered by the base
22 material microstructure. AM defects can form in the bulk, near the surface, and can also be associated
23 with the external surfaces formed during the material consolidation process. AM defects are also highly
24 material and process dependent, i.e., polymer-based processes produce different types of defects than
25 the metal fusion processes. Where similarities exist, they tend to be within specific types of material and
26 process combinations, for example, metal-based laser powder fusion processes tend to produce similar
27 types of defect structures. The diversity in AM has in general precluded concentrated evaluation of
28 defect structures resulting in limited qualitative and weak quantitative understanding regarding the
29 nature of AM defects, how they influence material performance, and what levels should be accepted.
30 Internal defects may include inclusions and oxides but in general involve voids and interfaces that form
31 as additional material is added to the preceding deposit. These defects may be influenced by
32 characteristics of the feedstock and are also highly dependent on the localized process conditions at the
33 point of consolidation. Process and material specific maps can be constructed to identify defect regimes,
1 but these provide little guidance on specifics such as volume fraction, size, morphology, and in
2 particular, their quantitative effect on material performance. For example, 3 types of defects are
3 commonly recognized in laser powder bed fusion including lack-of-fusion, keyholing, and balling. They
4 also are known to generally occur in certain regions of the process window. But details regarding size
5 morphology and specific impact on performance is generally unquantified.
6 Some bulk (internal to the material) and subsurface defects can be mitigated or “healed” through
7 subsequent thermal processing. For example, HIP is commonly used to address residual voids left by the
8 laser powder bed fusion process. The effectiveness of such treatments however can depend on starting
9 material condition, the alloy, and of course HIP conditions itself. HIP effectiveness is generally
10 determined on a case-by-case basis and done so experimentally.
11 Similarly, surface defects may be mitigated by machining, abrasive and /or chemical milling, peening and
12 or other surface treatments. The effectiveness of milder surface remediation methods are also very
13 process and material specific and determined empirically. Simple measures of surface roughness as
14 provided by 2D stylus and even 3D optical interferometry are not sufficient to fully characterize the
15 nature of some of the surface topology generated in AM processes. For example, deep surface crevices
16 that can be left by the metal laser and e-beam powder bed fusion processes that are well beyond the
17 line of sight of the 3D optical methods.
18 Guidance on how the industry might begin to address some of the above may come from prior industrial
19 and academic experiences. The metals casting industry defines and grades materials into classes based
20 on defect size and frequency. If a link between defect characteristics and material performance can be
21 established, a similar microstructurally based grading scheme may be possible for AM. Fracture
22 mechanics and the extended empirical methods of Murakami, Kitagawa-Takahashi and others have
23 been used to link idealized defects to material performance – in particular fatigue. Process specific
24 characterization of AM defects might lead to useful assessments of material performance using such
25 methods.
26 Gaps –
27 1. Catalogs of process specific defect types – process and material specific

28 2. Qualitative and quantitative models that link defect structures to material performance
29
30 Additional detail follows below. There is a broad need to share knowledge on acceptance criteria for
31 typical defect structures. See a similar gap: Gap NDE8: NDE Acceptance Criteria for Fracture Critical AM
32 Parts. The two identified gaps below need to be accomplished prior to establishing consensus on
33 acceptance criteria which are application specific.
34 Published Standards and Related Materials
35 In a review of existing documents, the following was noted:
1  The ISO/ASTM 52900-21 reference standard on terminology only mentions porosity. It does not
2 mention flaw, defect, cracks, discontinuity, etc. AWS D20.1M:2019 also does not define
3 terminology for defects. ASTM guides on AM processes also do not provide catalogs of process
4 specific defects.
5 Documents that may be more closely applicable include the following:
6  ASTM E3166-20e1, Standard Guide for Nondestructive Examination of Metal Additively

7 Manufactured Aerospace Parts After Build
8  ISO/ASTM TR 52906:2022, Additive manufacturing — Non-destructive testing — Intentionally
9 seeding flaws in metallic parts
10
12  ISO/ASTM DTR 52905, Additive manufacturing of metals — Non-destructive testing and

13 evaluation — Defect detection in parts
14  ASTM WK75329, New Practice for Nondestructive Testing (NDT), Part Quality, and Acceptability
15 Levels of Additively Manufactured Laser Based Powder Bed Fusion Aerospace Components
16
17 New Gap FMP10: Catalogs of process specific defect types and terminology. Catalogs of process
18 defects would be useful for diagnosing and correcting an AM process or choosing an appropriate post-
19 processing step to eliminate or minimize the deleterious effect of defects on the final part performance.
20 Such catalogs are not generally available for AM processes. Terminology is an important part of these
21 catalogs. Defect terminology is being defined inside NDE and process monitoring standards for metals.
22 However, there is a need to provide unified terminology that also covers more materials and AM
23 processes. The terminology should also cover defects detectable by destructive as well as non-
24 destructive methods. This should include surface defects. See also gap NDE1 on Terminology for the
25 Identification of AM Anomalies Interrogated by NDE Methods.
26 R&D Needed: ☒Yes; ☐No; Maybe
27 R&D Expectations: Terminology does not require R&D; however, R&D may be required to correctly
28 diagnose the cause of defects for some processes and materials.
29 Recommendation: Develop defect terminology for AM processes and parts defects; Develop catalogs of
30 process specific defects
32 Organization: ASTM, AWS, SAE, potentially other SDOs, NIST, national labs, DoD, NASA

35 Repair; ☐Data

10 ☒New
11
12 New Gap FMP11: Assessment of models linking defect structures and material performance.
13 Structure-property models for AM defects are needed to support acceptance criteria for part
14 qualification. Guidance and technical reports are needed on the use of existing models and the
15 development of new models.
18 Recommendation: Develop guides and technical reports on current structure-property models for
19 defects and the development of new models. Publish high fidelity, pedigreed datasets for structure-
20 property model validation.
22 Organization: ASTM, AWS, SAE, potentially other SDOs, NIST, national labs, DoD, NASA

25 Repair; ☐Data


7 ☒New
8 Other Finished Material Properties Standards Activity Since Roadmap v2 – Relevance to

9 Sections/Gaps Not Yet Determined
11  SAE AIR7352, Additively Manufactured Component Substantiation (Oct 2019)
13  ISO/ASTM WD 52919-1, Additive manufacturing -- Test method of sand mold for metal casting --
14 Part 1: Mechanical properties (ASTM WK70206)
15  ISO/ASTM WD 52919-2, Additive manufacturing -- Test method of sand mold for metal casting --
16 Part 2: Physical properties (ASTM WK70207)
17  ASTM WK74302, Specification for Manufactured Polymeric Ultraviolet (UV)-Cured Structures for
18 Residential Construction
19  ISO/ASTM WD 52919-1, Additive manufacturing — Test method of sand mold for metalcasting
20 — Part 1: Mechanical properties
21  ISO/ASTM WD 52919-2, Additive manufacturing — Test method of sand mold for metalcasting
22 — Part 2: Physical properties
23 2.3 Qualification & Certification

25 Each section in this roadmap discusses various issues and relevant standards at some point in the
26 lifecycle of an AM part. The goal of this chapter is to look at those issues in the context of applicable
27 qualification and certification (Q&C) procedures. Ultimately, all of the gaps identified in this roadmap
28 relate in some respect to Q&C.18
18
Accompanying this roadmap is a spreadsheet listing the identified gaps and applicable Q&C categories.
1 Whereas AM produced components must be tested for performance much the same as traditionally
2 manufactured items, there will be aspects unique to AM that must be addressed before such
3 components are deployed. This is especially the case for mission and safety-critical components and
4 applications. A critical part may be required to be built from qualified material, using qualified
5 processes, etc. Suffice it to say that there are many types of qualifications that can be discussed within
6 the scope of AM. As such, Q&C is a major area of focus for AM.
7 The first part of this section focuses on industry documents and related activities that provide guidance
8 on suggested or necessary components of an acceptable qualification procedure. The next part
9 discusses the approach to qualification and certification within different industry sectors and related
10 issues, including where there is a need for further standardization work or guidance to address such
11 issues.
12 2.3.1.1 Q&C Terminology
13 Qualification is defined in ISO/ASTM 52900:2021, Additive Manufacturing - General Principles -

14 Fundamentals and vocabulary as:
15 Qualification. process of demonstrating whether an entity is capable of fulfilling specified

16 requirements
17 Note 1 to entry: In additive manufacturing, qualification typically involves parts, materials,
18 equipment, operators and processes.
19 Certification is defined in ISO/IEC 17000:2020, Conformity Assessment - Vocabulary And General

20 Principles as:
21 Certification. third-party attestation related to an object of conformity assessment, with the

22 exception of accreditation
23 A formal definitional distinction therefore is that certification describes something done by an

24 authorized third party independent of the person or organization that provides the product, as well as
25 the user or customer of the product.
26 One of the major issues in the discussion of Q&C in AM is the ambiguity of terms and their usage. For
27 example, ISO 9000:2015, Quality management systems – Fundamentals and vocabulary, does not define
28 qualification or certification, but defines verification and competence and notes that qualification is
29 sometimes used as a synonym for each:
30 Verification: Confirmation, through the provision of objective evidence, that specified requirements
31 have been fulfilled
32  Note 1 to entry: The objective evidence needed for a verification can be the result of an
33 inspection or of other forms of determination such as performing alternative calculations or
34 reviewing documents.
1  Note 2 to entry: The activities carried out for verification are sometimes called a
2 qualification [emphasis added] process.
3  Note 3 to entry: The word “verified” is used to designate the corresponding status.
4
5 Related terms defined in ISO/IEC 17000:2020 are:
6 Verification. confirmation of truthfulness through the provision of objective evidence that

7 specified requirements have been fulfilled
8 Note 1 to entry: Verification can be applied to claims to confirm the information declared with
9 the claim regarding events that have already occurred or results that have already been
10 obtained.
11 Validation. confirmation of plausibility for a specific intended use or application through the
12 provision of objective evidence that specified requirements have been fulfilled
13 Note 1 to entry: Validation can be applied to claims to confirm the information declared with the
14 claim regarding an intended future use.
15 Terms may be defined in specific contexts. For example, verification and validation are defined and/or
16 discussed in:
17  ASME VVUQ 1 – 2022, Verification, Validation, and Uncertainty Quantification Terminology in

18 Computational Modeling and Simulation
19  DOT/FAA/TC-20/42, Model-Based Systems Engineering and Model-Based Safety Analysis: Final
20 Report
21  IEEE 1012-2016 - IEEE Standard for System, Software, and Hardware Verification and Validation
22 ASME VVUQ 50, Verification, Validation, and Uncertainty Quantification of Computational Modeling for
23 Advanced Manufacturing, is being developed. It will cover procedures for verification, validation, and
24 uncertainty quantification in modeling and computational simulation for advanced manufacturing. Four
25 key areas where they wish to develop content are: additive manufacturing, subtractive manufacturing,
26 uncertainty in manufacturing, and process control.
27 Aside from ambiguities in formal definitions, there are sometimes differences in how terms are used by
28 industry sector. The aerospace industry utilizes SAE AS9100D, Quality Management Systems -
29 Requirements for Aviation, Space, and Defense Organizations. The defense industry approach to
30 certification of parts/criticality of parts aligns with the aerospace industry practice except for
31 terminology. The aerospace industry qualification procedure equates to what the defense industry
32 describes as certification. Terminology within the medical community is defined in law or regulation.
33 In addition to the source documents already mentioned, the ISO Online Browsing Platform is a useful
34 resource for researching how terms are defined in various standardization contexts.
1 Gap QC1: Harmonization of AM Q&C Terminology. One of the challenges in discussing qualification and
2 certification in AM is the ambiguity of the terms qualification, certification, verification, and validation,
3 and how these terms are used by different industrial sectors when describing Q&C of materials, parts,
4 processes, personnel, and equipment.
7 Recommendation: Compare how the terms qualification, certification, verification, and validation are
8 used by industry sector. Update as needed existing terminology standards to harmonize definitions and
9 encourage consistent use of terms across industry sectors with respect to AM.
11 Organization: ASTM F42/ISO TC 261, AAMI, ASME, SAE
12 Lifecycle Area: ☐Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished

14 Repair; ☐Data


24 ☐New
25 V3 Update: This is an ongoing effort.

26
27 2.3.1.2 Q&C Framework – Prescriptive versus Performance-based
28 To understand the Q&C methodology within an industry or when comparing approaches used by
29 different industries, it is important to recognize that the framework used for Q&C often differs
30 significantly. One useful metric in comparing Q&C frameworks is to note the degree to which the
31 certifying entity dictates “how” a task is done versus only dictating “what” the outcome of the task must
1 be. This consideration of “how” versus “what” establishes a range of possibilities for the Q&C
2 framework, from fully prescriptive at one extreme telling the provider exactly how to proceed to being
3 fully performance-based at the other extreme giving the provider only the performance requirements of
4 the final product. Generally, the reality exists as a blend of the two philosophies falling somewhere
5 between these extremes. Performance based Q&C offers the providers the most flexibility and provides
6 a better environment for innovation. This arrangement requires trust between certifier and provider.
7 This trust is usually enforced indirectly by significant financial or legal motivations on the provider to
8 ensure the product meets its certification goals. In the opposite extreme, a prescriptive solution tends to
9 reduce innovation in return for a better-defined process and product. A more prescriptive solution is
10 common when the certifying agency has a direct stake in the product outcome, i.e., the certifier is also
11 the customer. The prescriptive approach is often chosen when the situation offers limited consequences
12 on the provider for not performing, other than not being compensated for that job, i.e., contract work.
13 Therefore, the motivating factors on the provider tend to guide the Q&C framework. If the provider’s
14 future business case relies heavily on providing a safe, reliable product at certification, performance-
15 based Q&C is generally useful. When these motivations are not as strong or when the certifying entity
16 has a direct stake in the outcome, the Q&C framework tends more toward prescriptive.
17 A microcosm reflecting this variety of Q&C framework is evident within the commercial sector. An
18 Original Equipment Manufacturer (OEM) may be operating under largely performance-based rules to
19 produce their device; however, when the OEM contracts to a provider to produce for them, the OEM
20 serves as a “certifier” to the provider, and the OEM will typically be prescriptive in their engagement to
21 ensure the product complies with their internal standards.
22 The Q&C framework employed can have an effect on the role of standards and type of standards that
23 are most useful within the framework. Standards and guidance material may vary depending on where
24 the Q&C framework falls in the spectrum from prescriptive to performance based. Within this chapter,
25 there are perspectives from a variety of industry sectors. The approach used by each falls somewhere
26 along this continuum. The reader will find certifying agencies that have a purely regulatory role such as
27 the FDA and FAA leaning toward performance-based methods, whereas agencies that hold more a more
28 direct stake in the products tend to be more prescriptive, such as NASA and cases within the DOD.
29 However, in general, there is movement toward having government certification processes be less
30 prescriptive and more performance-based across the board to encourage innovation and competition.
31 The motivations and consequences will determine the correct balance in the Q&C framework through
32 sometimes tough lessons learned.
33 2.3.2 Identified Guidance Documents

34
35 Input was invited from all AMSC participants on relevant qualification procedures. What follows below
36 reflects what was submitted for inclusion in this section in no particular order. In each case, authors
37 were invited to provide background on the impetus for the document or initiative, what the group
38 hoped to accomplish, and next steps.
1 2.3.2.1 U.S. Food and Drug Administration (FDA) Guidance on Technical Considerations for
2 AM Devices
3
4 Additive Manufacturing (AM) is a rapidly growing technology in the medical field. Since 2010, the
5 number of medical devices cleared each year by the FDA (Agency) has risen steadily. FDA noted the
6 increase in AM devices in the fields of orthopaedics, dentistry, and oral and maxillofacial surgery, and
7 began to investigate both AM applications and technologies. By gaining experience through
8 independent research and careful evaluation of submissions, the Agency was able to clear over 250 AM-
9 fabricated devices by the end of 2022.
10 In late 2014, FDA held a public workshop to discuss the technical considerations for AM medical devices
11 (e.g., best practices, current challenges, opportunities for growth). Small and large medical device
12 manufacturers, patient advocacy groups, scientists, standards development organizations (SDOs), and
13 other medical industry stakeholders attended to discuss five broad themes: (1) materials; (2) design,
14 printing, and post-printing validation; (3) printing characteristics and parameters; (4) physical and
15 mechanical assessment of final devices; and (5) biological considerations of final devices, including
16 cleaning, sterility, and biocompatibility. This constructive event catalyzed increased FDA outreach and
17 stakeholder interactions, resulting in the production of a Draft Guidance (May 2016). After public
18 comment, the Final Guidance on Technical Considerations for Additive Manufactured Devices: Final
19 Guidance for Industry and Food and Drug Administration Staff (AM Technical Guidance) was published in
20 December 2017.
21 FDA also recognizes that AM increases the role of clinicians (e.g., physicians, surgeons, therapists) in the
22 creation of medical devices either by 3D printing patient-specific anatomic models (Models) from
23 medical imaging at the point of care or directing engineers how to design a cleared patient specific
24 implant that will be manufactured and shipped to them for a specific surgical procedure. In August 2017,
25 FDA and the Radiological Society of North America (RSNA), an international clinical radiology society,
26 held a jointly sponsored meeting on the topic of 3D Printed Patient-specific Anatomic Models. This
27 meeting focused on clinically used Models to identify current best practices, levels of benefit vs. risk for
28 different intended uses, and gaps in clinical evidence needed to perform effective regulatory review of
29 those Models. The meeting underscored the need for continued education and development of
30 standards and best practices in both the clinical and regulatory settings.
31 In 2022, the FDA and the Veterans Health Administration (VHA) held a Virtual Public Workshop – “3D
32 Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of
33 Device and Implementing a Quality Management System” to share VHA’s experiences using 3D
34 printing/additive manufacturing in their hospitals. The workshop provided a forum for VHA and other
35 stakeholders to present and discuss their experience for other healthcare facilities considering 3D
36 printing medical devices to understand the requirements to implement a quality management system
37 (QMS).
38 In 2021, FDA released a discussion paper titled “3D Printing Medical Devices at the Point of Care” which
39 provided background information on 3D printing and proposed potential PoC manufacturing scenarios
1 for public comment. Continued interaction between FDA and healthcare stakeholders will be key to
2 ensuring safe and effective innovation across the industry and in clinical practice.
3 Goals and Results of the FDA AM Program

4
5 The FDA has three closely related goals with its AM program, including the AM Technical Guidance,
6 informational videos, presentations and research publications, and FDA 3D Printing website.
7 Goal 1: Describe the type of technical information that may be required to meet regulatory
8 requirements for clearance or approval and to meet post-market inspection and compliance
9 requirements.
10 A Guidance document is used by FDA to provide the Agency’s current thinking when an industry or
11 technology is new to the market or to provide a groundwork for safety and effectiveness testing and
12 metrics. The AM Technical Guidance is a cross-cutting document that adds to existing guidance
13 documents that focus on a specific submission type or a single device category. The document describes
14 recommendations, best practices, and advisories for different aspects of the additive manufacturing
15 workflow; however, since the scope of the document is broad, it does not list specific acceptance criteria
16 or prescriptive actions. The sponsor (company or person submitting a file to the FDA) must determine
17 which recommendations and considerations are applicable to their medical device, process, and
18 regulatory status. Resources such as CDRH Device Advice19 and the FDA 3D Printing20 websites also
19 provide information that may help sponsors to make those determinations.
20 Unlike other regulatory bodies like FAA, the U.S. FDA does not “certify” any aspect of specific medical
21 devices or their production. However, premarket clearance or approval from the FDA is necessary to
22 market many medical devices in the U.S. Devices are reviewed using general risk-based criteria set by
23 statutes and regulations21 and clarified in process or device-specific guidance documents. The Agency
24 aims to provide transparency about the information required or recommended for a given device or
25 submission. This transparency is especially important with emerging technologies such as additive
26 manufacturing.
27 Goal 2: Improve the introductory regulatory and technical information for the increasing number of
28 stakeholders that are new to the medical device industry.
29 In addition to aiding traditional medical device manufacturers, the FDA anticipates that the AM program
30 will help many research labs and early stage companies to identify potential challenges and incorporate
31 established best practices, systems engineering approaches, and comprehensive quality systems into
32 their processes. This may be important for research groups and laboratories that wish to begin clinical
19
CDRH Device Advice: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
20
FDA 3D Printing Website: https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-
medical-devices
21
CFR for med devices (21 CFR 800-1099)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=800&CFRPartTo=1099
1 trials with AM devices and medical products made in house, but that would have previously required
2 external manufacturing partners who would have assisted with the regulatory process.
3 Goal 3: Highlight best practices for the industry in an easy to understand manner that could be used
4 by those who are allied to the medical device area but who make products that are not typically
5 inspected or reviewed (i.e., Class I Medical Devices) and those who may not be traditional medical
6 device manufacturers (e.g., researchers, clinical staff).
7 The FDA’s AM Technical Guidance, website, and industry presentations represent the Agency’s current
8 thoughts on the best practices for AM design, manufacturing, and validation processes. Even if a
9 particular medical product does not require clearance or approval before marketing, the Agency
10 believes this information can be applicable to all types of medical product development and production
11 workflows regardless of the regulatory requirements.
12
13 2.3.2.2 Nadcap Program
14
15 Nadcap is an industry managed program, administered by the Performance Review Institute (PRI),
16 devoted to improving quality and reducing costs of critical process accreditations throughout the
17 aviation, defense, and space industries.22
18 In October 2013, the Welding Task Group was assigned responsibility to assess the industry needs and
19 develop audit criteria capable of assessing suppliers utilizing additive manufacturing technology.
20 Analysis demonstrated that the Task Group would be best suited developing audit criteria to assess laser
21 and electron-beam powder bed variants of the process. During the period 2014 to 2016, a sub-team of
22 the Task Group, as well as invited industry experts, including equipment and powder manufacturers,
23 developed and verified various drafts of audit criteria via trial audits. This culminated in the approval of
24 the audit criteria AC7110/14, Nadcap Audit Criteria for Laser and Electron Beam Metallic Powder Bed
25 Additive Manufacturing, which was released for use in early 2017.
26 Concurrent with the checklist development, existing welding auditors were theoretically and practically
27 trained in the technology and then examined to qualify them to conduct audits to this new audit criteria.
28 Audits already have been performed and suppliers accredited to the audit criteria.
29 The Task Group made an initial revision based on comments from users of the audit criteria. A further
30 revision was subsequently made once industry standards became available, to ensure proper alignment
31 with industry requirements.
32 The AC7110/14 audit criteria are available for downloading at no charge to any person registered in
33 eAuditNet (www.eauditnet.com). Once registered, the audit criteria can be found via Resources /
34 Documents / Audit Criteria / Welding. In addition to AC7110/14, AC7110, Nadcap Audit Criteria for
22
More information on the Nadcap program can be found at https://p-r-i.org/nadcap/about-nadcap/
1 Welding/Torch and Induction Brazing and Additive Manufacturing, should also be downloaded, as
2 AC7110 is a core checklist required for all of the welding audit criteria.
3 On March 1, 2023, the Nadcap Management Council approved the development of a new task group for
4 Additive Manufacturing to address this technology. It is anticipated that this group will be functional by
5 the end of 2023.
6 2.3.2.3 Aerospace Mission Success Improvement Workshop (MSIW)

7
8 Version 2 text (to be updated) on Mission Assurance Information Workshop (MAIW) which MSIW
9 replaces
10 The Aerospace Corporation sponsors a yearly workshop involving subject matter experts (SMEs) from
11 the U.S. space community that come together and evaluate specific mission assurance issues important
12 to the space enterprise. Examples of previous topics include counterfeit parts prevention strategies, root
13 cause investigation best practices guide, and supplier risk evaluation and control. For each topic of
14 interest, a team is created that is composed of SMEs from various industry, academic, and government
15 institutions. The team is charged with addressing the particular question of interest culminating in an
16 out brief to the community and a final report.
17 In August 2015, a team was stood up for a 3-month term to examine mission assurance considerations
18 relative to additive manufacturing. Because of the short timeframe, the team realized that this would
19 need to be an initial study that could feed into a more comprehensive evaluation during future MAIW
20 workshops. For a starting point, the members of the team polled their SMEs to come up with a group of
21 questions specific to potential risks of utilizing AM technologies. The goal was to help mission assurance
22 professionals, who are not necessarily subject matter experts, to begin to understand AM-specific issues
23 that need to be addressed when evaluating the insertion of AM parts into flight systems. To that end,
24 every question was supported with a background statement, a short discussion of the issue, and an
25 assessment of the criticality of the issue. More than 50 questions were captured in a chart deck that at
26 the time of this writing was currently in the final clearance process but will eventually be available to the
27 community.
28 2.3.2.4 Composite Materials Handbook-17 (CMH-17) and Metallic Materials Properties

29 Development and Standardization (MMPDS) Handbook
30
31 These two guidance documents are heavily used as part of the qualification process for metal and
32 composite materials. These documents both are based in volunteer organizations that have been active
33 for decades in rigorously reviewing data and statistical analyses for publication of material allowables.
34 As additively manufactured materials are expanding into regulated areas, these handbook organizations
35 are developing new volumes that will include material allowables and qualification and certification
36 guidelines. AM data are not currently available in either handbook; however, both organizations are
37 considering including them in future revisions.
1 Composite Materials Handbook -17 (CMH-17)
2 History: CMH-17 has a long history beginning in 1943 with the initial publication of the Army-Navy-
3 Commerce (ANC) Bulletin 17 Plastics for Aircraft (Air Force, Navy, and Civil Aeronautics Document). In
4 1959, the handbook “MIL-HDBK-17 Plastics for Air Vehicles” was first released utilizing content from the
5 ANC Bulletin. In 1978, an industry and government group (Coordination Group) was formed followed by
6 the release of MIL-HDBK-17B Volume 1 in 1988. Since that time, several revisions and volumes have
7 been published including polymer matrix, metal matrix, ceramic matrix, and structural sandwich
8 composites. In 2012, the Handbook name was formally changed from MIL-HDBK-17 to CMH-17 and is
9 now published by SAE. There are currently 6 volumes in the series.
10 Since the first publication of the CMH-17, the goal has been to create, publish, and maintain proven,
11 reliable engineering information and standards subjected to a thorough technical review, and to support
12 the development and use of composite materials and structures. The Handbook has been successful in
13 maintaining a volunteer organization of experts and publishing the information to the international
14 composites community. Through training and tutorials, CMH-17 has extended its reach to suit user
15 needs. Additional information is available at www.cmh17.org.
16 Role in Certification: CMH-17 is an accepted source for composite material allowables recognized by the
17 FAA. FAA AIR100-2010-120-003 states that National Center for Advanced Materials Performance
18 (NCAMP) allowables are acceptable for showing compliance with polymer matrix composites and they
19 must be validated as being applicable for an applicant’s application by the provisions listed in AIR100.
20 Although CMH-17 is not specifically listed in AIR100, CMH-17 has adopted NCAMP procedures. The
21 material values published in CMH-17 are not acceptable for design unless applicants follow the
22 equivalency procedures provided in NCAMP and CMH-17 to validate that the published values are
23 applicable for that applicant’s product.
24 Content: CMH-17 is an evolving document that reflects the state of the art in composite materials.
25 Periodic updates are made to maintain updated references to proven standards and engineering
26 practices, as well as up-to-date reliable composites data. Current areas of development include
27 application focused guidelines such as Engine Applications and Crashworthiness, as well as new data for
28 adhesives, core, thermoplastics, repair, and other new materials data linked to publicly -available
29 material and process specifications.
30 Non-Metallic Additive: In 2018, a new group under CMH-17 was formed to develop a seventh volume
31 focused on non-metallic additively manufactured materials. The Additive Manufacturing Coordination
32 Group is actively developing content through five Working Groups: Data Review, Design & Analysis,
33 Materials & Processes, Statistics, and Testing. Initial guidelines and data are focused on polymer AM,
34 primarily through available qualification data. As part of a Federal Aviation Administration (FAA) led
35 effort, qualification data of a polymer AM material has been generated and submitted to CMH-17 for
36 consideration. The Additive Manufacturing Coordination Group is currently reviewing this data set for
37 publication in a future release of the handbook. Note: CMH-17 has historically been devoted to
38 composite materials. Composites, as additively manufactured polymers, are considered “process
1 dependent” materials. This being the case, material values published in CMH-17 are not acceptable for
2 design unless applicants follow the equivalency procedures provided in CMH-17 to validate that the
3 published values are applicable for that applicant’s product. It is expected that values published for AM
4 polymers will be subjected to these same procedures.
5 Metallic Materials Properties Development and Standardization (MMPDS) Handbook
6 History: MMPDS also has a long history beginning with ANC-5 published in 1937. The United States Air
7 Force (USAF) assumed primary responsibility for continuing development of the Handbook in 1954,
8 recruited Battelle Memorial Institute as secretariat and changed the program name to MIL-HDBK-5 in
9 1956. Battelle has maintained and published the Handbook since 1957, serving as an impartial agent to
10 collect and analyze industry data and to publish statistically valid design allowables. In 1997 the
11 Industrial Steering Group (ISG) was formed to supplement government funding. In 2003, the Federal
12 Aviation Administration took over the government oversight role and changed the name of the
13 document to the Metallic Materials Properties Development and Standardization (MMPDS) Handbook.
14 The ISG is currently composed of 48 companies from 12 countries. The Government Steering Group
15 (GSG) includes representatives of the FAA, U.S. Air Force, U.S. Army, U.S. Navy, Defense Logistics
16 Agency, and NASA. Additional information is available at www.mmpds.org. Together, the ISG and GSG
17 form the MMPDS Coordinating Committee.
18 Role in Certification: The MMPDS Handbook is an accepted source for metallic material and fastener
19 system allowables for conventional metals recognized by the FAA, all departments and agencies of the
20 Department of Defense (DoD), and the National Aeronautics and Space Administration (NASA) within
21 the limitations of the certification requirements of the specific government agency. Per FAA
22 Memorandum PS-AIR-MMPDS: (Subject: Metallic Material Properties Development and Standardization
23 (MMPDS) Handbook) A and B-basis design values are acceptable for compliance for material strength
24 properties and design values for aircraft certification and continued airworthiness without further
25 showing of compliance. A-/B-/S-Basis material allowables are often accepted as the basis for design
26 values for engine certification. Users are responsible for evaluating influence factors such as
27 temperature, surface treatments, etc., to compute design values for their specific application. Chapter 9
28 (Guidelines) are widely used by aerospace companies to develop proprietary material allowables for
29 materials that are not included in the MMPDS Handbook.
30 Content: The Handbook contains design information on the mechanical and physical properties of
31 metallic materials and joints commonly used in aircraft and aerospace vehicle components and
32 structures. Chapter 9 (Guidelines) documents the test standards, data requirements, and statistical
33 algorithms required for consideration for each type of property reported. For example, A-/B-Basis static
34 strength values require no less than 100 tests with material drawn from 10 heats/10 lots of metal fitted
35 with three-parameter Weibull or Pearson Type II probability distribution functions or 299 tests using a
36 non-parametric method. Test data generated by industry suppliers and users are submitted to Battelle
37 for analysis using guidelines documented in MMPDS Chapter 9. Results are reviewed at twice yearly
38 MMPDS General Coordination Committee (GCC) meetings for approval. These coordination meetings
1 are open to the public. Each year, new alloys are added, guidelines are updated, and revisions are made
2 to existing sections after ISG and GSG review and approval.
3 Additive Metals: MMPDS has had limited exposure to additive manufacturing materials. Data for SAE
4 AMS 4999 (LAM Ti 6-4) was submitted in 2003 but the GCC decided that the data submitted did not
5 meet the existing requirements to support publishing material properties in MMPDS. Beginning in 2011,
6 the Emerging Technology Work Group (ETWG) was organized and began a focused effort to develop
7 guidelines appropriate for data generation, analysis, and publication of material allowables for process
8 intensive metals, including AM alloys. An interim report, Guidelines for Emerging Materials and
9 Technologies documented the progress but was closed in the spring of 2016 at the Government Steering
10 Group’s (GSG) request because the underlying technology and supporting infrastructure was considered
11 not mature enough to publish generic material properties. Industry had produced few public
12 specifications, a major barrier to admission into the Handbook, and there were concerns that the
13 variability of material being produced was too great, and the sources of that variability insufficiently
14 understood.
15 The ETWG continued to engage with government, industry, and SDOs to support technology
16 improvements. In the last five years, the GCC decided that process intensive materials and joining
17 technologies (such as AM metals and friction-stir welding) should be published as a separate volume
18 rather than as new sections of the existing Handbook. Between 2018 and 2022, the GCC approved 16
19 agenda items documenting guidelines, definitions, specification content, data generation, data analysis,
20 and presentation guidelines for users. The GCC continues to work toward compiling the first edition of
21 MMPDS, Volume II. The target release is tentatively forecasted to be July 1, 2024.
22 The new volume will define the minimum requirements for the GCC to consider creating an entry. The
23 first edition will not include any material allowables. Because the guidelines remain undefined, most
24 businesses consider the risk due to possible changes too great to justify the investment in data
25 generation. MMPDS repeatedly warns the user that the Secretariat, the GCC, the GSG, and regulators
26 may require more information. This has always been the case, even for conventional product forms.
27 There are known gaps in the new volume. However, the data submission guidance is sufficient for
28 generating data in support of creating those future tables. Static material allowables will be labeled C/D-
29 Basis rather than A/B-Basis to remind users that additional effort will be required by regulators at the
30 FAA, DoD, and NASA. A new chapter has been added that will be expanded to assist users in that
31 process. The MMPDS program will solicit input from industry and government and continue to expand
32 and improve along with the science and engineering.
33 2.3.2.5 AWS D20

34
35 The American Welding Society (AWS) formed a standalone committee for the creation of an AM
36 standard in 2013 and published AWS D20.1/D20.1M:2109, Specification for Fabrication of Metal
37 Components Using Additive Manufacturing, in 2019.
1 The AWS D20 committee has created a comprehensive document that identifies requirements for AM
2 machine qualification, procedure qualification, and machine operator qualification, as well as fabrication
3 and inspection requirements for AM components. The D20.1 standard includes requirements for both
4 powder bed fusion and directed energy deposition metal AM processes. A graded approach is being
5 taken, with three different component classifications that determine the level of qualification and
6 inspection requirements.
7 The D20 committee is currently working on two documents, a revised D20.1 that would apply only to
8 processes with powder feedstock for either powder bed fusion or directed energy deposition and a new
9 D20.2 that would apply to processes with wire feedstock for directed energy deposition. Both
10 documents will continue to focus on qualification, with such application issues as component
11 classification, material chemical composition, build design, and acceptable mechanical properties not
12 specified by the standard.
13 2.3.2.6 NASA Standards for Additively Manufactured Spaceflight Hardware
14 Motivations
15 NASA human rated spaceflight programs have quickly embraced the promise of AM to benefit design
16 flexibility, cost, and schedule challenges of system development and manufacture. Each of NASA’s
17 current human spaceflight programs – the Artemis program with the Space Launch System, Human
18 Landing System, and Orion Spacecraft, as well as the Commercial Crew Program – is developing AM
19 hardware and establishing a significant future role for AM in these systems. In many cases, the timeline
20 for qualification of this early AM hardware and certification of its associated systems has been
21 condensed compared to the typical introduction of new manufacturing technology.
22 The primary motivation for NASA-STD-6030, Additive Manufacturing Requirements for Spaceflight
23 Systems, and NASA-STD-6033, Additive Manufacturing Requirements for Equipment and Facility control,
24 is the same as the predecessor documents (MSFC-STD-3716 and MSFC-SPEC-3717): to provide an overall
25 framework for the qualification, control, and implementation of AM processes for spaceflight hardware
26 over a range of criticalities. NASA-STD-6030 establishes basic policy for AM at the Agency level and
27 extends its applicable scope to more processes and material systems than its predecessors. The intent of
28 these documents is to provide a semi-prescriptive framework for AM implementations to successfully
29 achieve certification through tailoring the requirements to meet the unique needs of the project and the
30 provider’s environment.
31 NASA continues to work with many of the SDOs developing various types of standards products for the
32 AM ecosystem. These products continue to develop and are now frequently providing appropriate
33 direction for controlling specific aspects of the overall AM process. What has yet to evolve from the
34 SDOs is a clear, overarching, framework of standards that provides a common engineering practice to
35 govern the full AM production life cycle; therefore, NASA considers these standards necessary to define
36 a basic engineering practice for implementing the overall AM process in the context of NASA’s
37 overarching standards for materials, structures, and fracture control.
1 Objectives and Content
2 As stated, the primary objectives of NASA-STD-6030 and NASA-STD-6033 are to provide an overarching
3 framework of methodologies to meet the intent of existing NASA requirements in materials, structures,
4 and fracture control for AM parts. The standards were released in April of 2021 and are public
5 documents available on the internet at https://standards.nasa.gov .
6 The following principles guided the new NASA standards in their development and philosophy:
7  Define a manageable, systematic, and consistent approach to AM to allow the Agency to

8 evaluate risk and make consistent decisions regarding the certification of designs and hardware.
9  Integrate the AM process in a manner compatible with existing governing Agency standards.
10  Enforce discipline and systematic rigor throughout the AM process, from design to part.
11  Avoid defining the specifics of AM processes; instead define methodologies for qualifying and
12 controlling the processes.
13  Accommodate the use of internal and open industry standards as appropriate.
14  Provide NASA with opportunities for insight to gauge quality, completeness, and rigor through a
15 well-defined and predictable set of reviewable products governing the AM process.
16 To accomplish these goals, the NASA standards provide a framework of requirements for foundational
17 process controls and part production controls. The foundational controls begin with the implementation
18 of a Quality Management System (QMS) and the development of an AM Control Plan (AMCP). The AMCP
19 documents all tailoring of the requirements as agreed to for the AM implementation and replaces the
20 NASA standards as the governing document. Further foundational controls are established regarding the
21 qualification of AM material processes, establishing control of AM machines and facilities (through
22 NASA-STD-6033), and the systematic development and substantiation of AM material properties for use
23 in design and statistical process control. Only once these foundational controls are in place do the part
24 production controls get implemented to produce AM parts to a qualified process. The following
25 describes key products produced while establishing a qualified AM process and part production:
26 Foundational Controls
27  Equipment and facility Process Controls (NASA-STD-6033)

28 o An AM Equipment and Facility Control Plan (EFCP) is established to formalize AM
29 equipment process controls including feedstock management, contamination control,
30 digital data control and security, prerequisite machine calibration requirements,
31 preventive maintenance requirements, machine health tracking, and so forth.
32  Baseline AM material and process qualifications (NASA-STD-6030)
33 o Feedstock material, AM machine, and the AM process are indelibly linked in this
34 concept. Once fully defined, this combination is set as a “candidate AM material
35 process.”
1 o After successful evaluation of the candidate process, a Qualified Material Process (QMP)
2 is newly established (or shown equivalent to an existing QMP) for each individual AM
3 machine.
4  Material property development
5 o The development of AM material properties and their integration into the AM
6 ecosystem for use in part design, statistical process control, and the concept of
7 engineering equivalency demonstrate compatibility of material performance across
8 characterization activities and part implementations.
9 Part Production Controls
10  Design Evaluation
11 o A part classification system for evaluating risk is based on consequence of failure,
12 structural margins, and risks associated with the physics of the AM build process.
13  Part Process Control
14 o There is a requirement for a Part Production Plan (PPP) that outlines the cradle-to-grave
15 process for producing the AM part, including establishing the part integrity rationale
16 through process controls, nondestructive inspections, and proof testing.
17 o There are requirements for a formal Preproduction Article evaluation (PPA) and
18 Manufacturing Readiness Review (MRR), leading to a locked and Qualified Part Process
19 (QPP).
20 The resulting products of these controls (AMCP, EFCP, QMP, PDP, QPP) provide a consistent and
21 quantifiable set of deliverables for the Agency to reliably evaluate the implementation of AM parts.
22 2.3.2.7 ASME Y14.46
23 ASME Y14.46, Product Definition for AM, is a subcommittee formed by the ASME Y14 Engineering
24 Product Definitions and Related Documentation Practices Committee. The Y14.46 document addresses
25 Product Definition requirements that are specific to AM as well as requirements not specific to, but
26 elevated because of, AM. The sections reflect four main topics: 1) Part Definition, 2) Process, 3)
27 Verification and Conformance, and 4) Data Package Requirements.
28 The Verification and Conformance Section provides guidance on conformance to specifications for AM
29 products, in particular manufacturing imperfections meeting acceptable ranges, specified key
30 characteristics, and identification of acceptance criteria specific to using AM processes and the
31 associated level of reliability.
32 Surface finish specifications and inspection methodologies (including NDE, laser, non-contact, etc.) will
33 continue to be developed by both the ASME B89 Dimensional Metrology Standards Committee and
34 ASME B46 Classification and Designation of Surface Qualities Standards Committee.
35 The Y14.46 standard was published on June 8, 2022. This is an ANSI approved standard established
36 following review of comments received on the draft standard for trial use issued in 2017.
1 2.3.2.8 Underwriters Laboratories (UL)
2 Underwriters Laboratories (UL) is accredited by the American National Standards Institute (ANSI) as an
3 audited designator. UL promulgates the standard for safety ANSI/UL746C, Standard for Polymeric
4 Materials – Use in Electrical Equipment Evaluations, Seventh Edition, dated February 5, 2018, ANSI
5 approved June 30, 2022. This standard is maintained by the UL746C Standards Technical Panel
6 composed of various interests including: authorities having jurisdiction, commercial/industrial users,
7 producers, consumers, supply chain, testing/standards organizations, and general interests.
8 Standard
9 ANSI/UL746C contains requirements for parts fabricated from polymeric materials used to construct
10 electrical equipment. The standard describes test procedures for fabricated polymeric parts in specific
11 applications to evaluate specific criteria. The standard’s scope includes parts made by additive
12 manufacturing technology.
13 End-Product Evaluations
14 ANSI/UL746C specifies that end-product parts, or test specimens cut from the end-product parts, be
15 subjected to various tests, or application of historical data, for qualification. The following properties
16 may be addressed at the end-product level evaluation:
17  Thermal endurance
18  Electric strength / Volume resistivity
19  Impact resistance
20  Flammability
21  Tracking resistance
22  Resistance to electrical ignition sources
23  Permanence
24  UV & water/weathering resistance
25  Dimensional stability
26 Pre-Selection Data
27 UL also conducts material certification for preselection purposes. ANSI/UL746C specifies test specimens
28 printed, or cut from a printed part, in the specified dimensions may represent the end-product
29 applications where identical production parameters are used.
30 UL also administers a component recognition program category for plastics used for additive
31 manufacturing entitled: “[Plastics - Component] Plastics for Additive Manufacturing – Component
32 (QMTC2).” Materials certified under this category are identified by the material manufacturer and grade
33 designation.
34 Process parameters that are also specified, dependent on process, typically include:
1  Printer make & model
2  Build plane
3  Layer thickness
4  Hatch spacing
5  Post process method(s)
6  Infill
7  Raster angle
8  Print speed
9  Laser power
10  Air gap
11  Scan strategy
12 2.3.2.9 AIA Recommended Guidance for Certification of AM Components

13
14 In 2016, the Federal Aviation Administration (FAA) requested the Aerospace Industries Association (AIA)
15 to create a document outlining the considerations that should be made before utilizing Additive
16 Manufacturing in aerospace parts production. The AIA sponsored a technical working group comprising
17 technical leaders from over a dozen Original Equipment Manufacturer (OEM) airframe and powerplant
18 manufacturers, who worked for several years to create a best practices document. The document was
19 developed based on a gap analysis of the perceived needs versus technical realities and the missing
20 regulatory framework, which aimed to provide guidance on how to address and close those gaps.
21 The AIA Working Group for Additive Manufacturing report specifically addressed the unique aspects of
22 certifying AM components for aerospace applications. The resulting paper provided guidance for
23 compliance to specific Federal Aviation Regulations (14 CFR 2x.605, 2x.613m 23,2260, 33.15, and 35.17)
24 for metal powder bed fusion (PBF) and directed energy deposition (DED) additive processes. The final
25 report also discussed current industry best practices and considerations for material/process
26 development, part/system qualification, and development of material allowables and/or design values.
27 The authors of the report were experienced aerospace industry design approval holders (DAH) and users
28 of state-of-the-art additive equipment, thus providing a qualified and knowledgeable perspective on
29 these issues.
30 The final document was published in 2020. Since its initial publication, the document has been
31 frequently referenced by other standards bodies and used as an important reference document by
32 numerous aerospace OEMs and suppliers. However, the original version of the document did not
33 provide guidance on the use of AM in the maintenance, repair and operations (MRO) context and the
34 use of AM in fatigue and fracture critical situations. Therefore, the AIA has requested the working group
35 to continue their work on those two topics, and updates to the best practices document in those areas
36 will be forthcoming over the next two years. The updates will also include additional input on suggested
37 areas of research and development focus and investment for industrial, governmental, and standards
38 development organizations.
1 2.3.3 User Group/Industry Perspectives on Q&C
2 Whereas the prior section addressed focused efforts underway to develop guidance documents on
3 qualification and certification, this section endeavors to tie perspectives together by industry sector.
4 Philosophies and needs of the following sectors are discussed and gaps are identified: aerospace
5 (including civil aviation and spaceflight), defense, electronics, energy (oil and natural gas, nuclear), and
6 medical. In the case of the automotive and construction sectors, content is invited.
7 Each sector was asked to consider a number of topics related to Q&C in organizing its write-up. The
8 sector write-ups addressed these in varying degrees.
9  Intent and motivation of each of Q&C guidance and standard documents
10 Are there accepted key standards defining, guiding, or having strong influence over the overall AM Q&C
11 methodology in this sector? If yes, list them and provide a brief description of the documents’ role. The
12 documents should be listed in the prior section 2.3.2. Are there big picture view types of documents that
13 integrate all the relevant specs and guidance? How is the AM Q&C framework different from what
14 we’ve used in the past with non-AM systems?
15  Description of prescriptive versus performance-based aspects of Q&C in the industry (may be either
16 or combinations)
17 Relative to certification of systems containing AM hardware, does the industry sector primarily operate
18 on a performance or prescriptive basis regarding requirements / regulations? Provide a brief discussion
19 of typical sources of Q&C requirements (AM-specific or more general), regulatory and otherwise, for
20 context. How do those protocols influence the type of standards needed to define the AM Q&C
21 framework in the sector? (The answer may be “none are considered / needed…”)
22  Summary of framework of requirements (or trends in development thereof) in the following “Life
23 Cycle Area”
24
25 o Materials – Feedstock material controls, Final material quality controls, generation of
26 Material allowables and their substantiation
27 What standards are typically used for material quality control in the sector? What level of
28 feedstock and final material control is typically expected by regulators? Have common
29 expectations been set in the sector? Are current open industry standards published or in-work
30 that govern material quality considered acceptable to regulators within the sector?
31 How are AM material properties (allowables, design values) typically set within this sector? Are
32 their common standards for methodology for development of AM material properties? What
33 approach(es) is expected to prevail within the sector that provides sustained rationale for the
34 validity of material properties over time, across platforms and facilities?
1 *If design value substantiation is a part of part qualification, the discussion can be included in
2 “Part/Devices” or “Part Performance” section
3 o Process/Procedures – Process or Procedure Qualification, Process control and Statistical

4 Process Control (SPC)
5 How are AM processes (or procedures) commonly qualified within the sector? Is there a
6 common standard emerging that governs or guides qualification of AM processes in the sector?
7 Is there a clear distinction and common understanding between AM machine qualification and
8 AM process qualification within the sector? If so, briefly describe. Are the qualification
9 methodologies and criteria contained only within the context of company proprietary
10 information, or are there acceptable open industry standards available or in-work?
11 Are there specific expectations for AM process control within the sector? Do standard process
12 control documents (PCD) methods dominate?
13 o Machine/Equipment - Equipment control
14 How are AM equipment and facilities controlled within the sector? Are there any standards,
15 expectations, or common guidance used within the sector? Is AM equipment control considered
16 unique in any way within the regulatory context of the sector?
17 o Part/Devices – Part classifications, if used, and what they affect in Q&C, Design, Part and/or
18 Product Qualification. Difference in regulatory requirements by product type. Technical Data
19 Package expectations
20 Is there an emerging common definition for establishing AM part classifications within the
21 industry sector? If so, briefly describe the classification system commonly used. Does the sector
22 commonly use classifications for other common parts or processes, such as welds or castings?
23 Do part classifications currently play a role in governing the design, production, or quality
24 assurance aspects of AM hardware within the sector?
25 o Part Performance
26 What are the requirements in the definition and implementation of part performance
27 assessment? This may include (but is not limited to) methods for establishing design values and
28 design margins, identification and mitigation of potential failure modes for critical performance
29 characteristics, etc.
30 o Personnel/Suppliers - Personnel training
31 What role does structured personnel training play in the Q&C methodology within the sector?
32 Are there common standards available for AM personnel training and qualification in use within
33 the sector? Are training efforts mostly on the job (OTJ) within the sector? What is the role (and
1 current state) of training materials and certification programs developed by SDOs that is
2 relevant to the sector?
3 o Framework for enabling AM suppliers
4 Does this sector primarily rely on AM production contained within the “primes” / OEMs, or is
5 there a heavy reliance on independent AM production shops? Is there a common standard or
6 methodology emerging regarding how independent AM production shops are approved? In
7 general, what expectations do regulators have for control over independent suppliers? What is
8 the common expectation of the OEMs? Are there additional standards needed that would
9 enable more effective “requirements flow-down” from OEMs to lower tier suppliers?
10 o Requirements Integration
11 What is the availability of higher-level Q&C framework documents providing guidance on

12 integration of Q and C documents in individual technical areas? How well are different
13 documents (defined in specific Life Cycle area listed above) combined to achieve the overall part
14 and product level “Q and C state”?
15 o Quality Assurance
16 Are all the elements of the conventional quality assurance (QA) framework applicable to AM?
17 Are there unique AM considerations that need to be reflected in Q&C standards?
18 What are the typical (or emerging) expectations of statistical process control (SPC)
19 implementation in AM within the sector? What role does SPC play in the certification of AM
20 hardware within the sector?
21 Is there a different role inspections (both regular and NDE) play in the context of QA for AM?
22 Are there corresponding standardization gaps?
23  Summary of Q&C standardization gaps identified
24 2.3.3.1 Aerospace Industry
25 2.3.3.1.1 Civil/Commercial Spaceflight Industry
26 Intent and motivation of each of Q&C guidance and standard documents
27 Within the realm of NASA spaceflight activities, NASA has provided standards with requirements and
28 guidance over the past five years. The first documents released in 2017 were MSFC-STD-3716 and MSFC-
29 STD-3717. In 2021, NASA-STD-6030 and NASA-STD-6033 were released, essentially replacing the MSFC
30 standards. See section 2.3.2.6 for a more complete description of these documents. These standards
31 provide an overall framework to the implementation of AM and include requirements for all aspects of
1 material and process control, material property development, part planning and production. A core
2 feature of these standards is that they require the development of an Additive Manufacturing Control
3 Plan (AMCP) that tailors the requirements to the needs of the program or project and adapts the
4 requirements to a best fit to the methods of the organization serving as the cognizant engineering
5 authority and the AM production entity. The expectation is that the intent of the requirements will be
6 met as appropriate to the project and the AMCP, once approved, replaces the standard as the governing
7 requirements document.
8 Other spaceflight related activities, such as commercial satellite production and launch and similar
9 ventures, do not have an open, consensus Q&C standard that creates a common methodology. In these
10 sectors of spaceflight, internal company practices are independently reviewed and accepted by the
11 purchaser, similar to scenarios common in performance-based environments.
12 Description of prescriptive versus performance-based aspects of Q&C in the industry
13 Activities within the NASA spaceflight sector can span the range of prescriptive to performance-based
14 requirements frameworks depending upon the program. The intent within NASA is to move toward
15 adoption of NASA-STD-6030 methodologies across most AM implementations. The NASA-STD-6030
16 methods are most accurately described as prescriptive, given there are numerous “shall” statements
17 that need to be evaluated for compliance to their intent. This methodology is not prescriptive to a detail
18 level that includes design methods, AM parameter sets, or methods of part inspection. Rather, it is
19 prescriptive in requiring defined expectations for material and process control, acceptable levels of
20 material quality, minimum activities for material property characterization, etc. In general, a well-
21 controlled AM process operating rigorously under a quality management system needs only modest
22 adaptation to meet the intent of the NASA-STD-6030. The process of adjudicating the prescriptive
23 requirements into a tailored, mutually acceptable AMCP to control the AM process requires an open-
24 minded, collaborative effort. Currently, the resulting AMCP relies most heavily on proprietary
25 documents. This trend has started to moderate in cases of smaller entities toward the available open
26 standards that have been developed with sufficient control and specificity to be used in an environment
27 compliant with NASA-STD-6030.
28 Role of AM Part Classification in the requirements and standards framework
29 The NASA spaceflight sector has adopted a part classification system that permeates the Q&C
30 framework. The primary part classes are based on consequence of failure [A (high), B, and C (low)] and
31 are influential in many aspects of the AM value chain including machine and process qualification, AM
32 process control requirements for witness testing and surveillance, material allowable and design value
33 rigor, and part inspection requirements, to name a few.
34 Summary of framework of requirements (or trends in development thereof) in the “Life Cycle
35 Areas” described below
1  Materials – Feedstock material controls, Final material quality controls, Material allowables
2 and design value substantiation
3 The scope of feedstock controls is defined at a very high level in NASA-STD-6030, primarily identifying
4 the minimum aspects of controls expected to be enforced. Most commonly, larger entities follow
5 internal corporate feedstock specifications; however, the use of open industry standards has increased
6 recently as many of the SDO products provide controls expected within the NASA framework.
7 In NASA-STD-6030, the expectations for controls on final material quality are primarily defined at the
8 establishment of the Qualified Material Process. This allows for adaptation for part class and other
9 variables to be considered. The definition required for final material quality, including material
10 microstructure evolution in heat treatment (metals) is sufficient to form a basis for understanding
11 material equivalence in the AM process. The adoption of the standards portfolios of the AM SDO
12 community is hindered in this sector by the lack of definition of acceptable final material quality criteria
13 at a level sufficient to ensure continued material consistency and determine material equivalence.
14 The definition and substantiation of material allowables and design values continues to be a significant
15 standardization challenge. NASA-STD-6030 provides a framework for the development of these values
16 and a required process control methodology that is intended to ensure the ongoing validity of these
17 properties throughout production as applied to specific parts. The NASA standard does not purport to
18 be the correct or final policy for the development of AM allowables and design values. NASA continues
19 to support the SDOs such as MMPDS and CMH-17 in their activities in this regard. There remains a
20 philosophical difference of opinion across the sector regarding the development and implementation of
21 AM material allowables and design values. The contrasting views are not easily articulated but can be
22 fairly summarized into two basic camps: 1) AM properties should be developed through mostly
23 traditional policies under the assumption that a qualified process following a published, public industry
24 standard will sufficiently control the process such that a one-time sampling of sufficient lots and
25 specimens can be used to define allowables in the traditional sense. In this methodology, there is an
26 expectation that there will be a “further showing” rationale provided by AM users to demonstrate their
27 process is compliant to the standard. Or, 2) AM properties are to be developed on defined, qualified
28 processes that are characterized sufficiently to provide a broad basis of information used to
29 demonstrate continuous material engineering equivalency is maintained by process controls throughout
30 the AM value chain from qualification criteria, to allowables and design values, to process witness
31 testing, through to part first article evaluations. This approach allows for potentially smaller up-front
32 characterization scope in exchange for the on-going controls that ensure the process of each AM
33 machine is producing material that is consistently equivalent in an engineering sense. The NASA-STD-
34 6030 subscribes to this latter methodology. The prevailing approach will be dictated by the
35 demonstrated reliability of the AM process over time. The first, traditional approach requires significant
36 assumptions in the current reliability of the process.
37  Process/Procedures – Process or Procedure Qualification, Process control and Statistical Process

38 Control (SPC)
1 The method of qualifying AM processes and machines remains poorly defined in the SDO space as
2 related to this sector, with a scattering of standards addressing various aspects of the AM qualification
3 process. One particular challenge in this regard is a lack of standard terminology related to qualification
4 of AM machines and processes. Confusion persists about what is machine qualification and what is
5 process qualification, how the two are related, and what represents adequate scope of the required
6 qualification evaluations. With respect to regulatory expectations in this sector, there does not appear
7 to be a clear convergence across the SDO space in this regard. Within NASA activities, NASA-STD-6030
8 attempts to put sufficient definition to these topics to permit a common understanding and a basis for
9 conversation and negotiation. The NASA standard separates machine calibration and confirmation of
10 functionality as a separate precursor activity to the qualification process. The qualification process is
11 viewed as an affirmation that a defined machine and process parameter combination produces material
12 of appropriate quality for the application. This is referred to as a Qualified Material Process (QMP). The
13 qualification activities required are generally more comprehensive than what appears in currently
14 available SDO offerings. Evaluations of resulting material are required in as-built and final states for
15 microstructure and defect state, including key operations within the process, e.g., in powder bed fusion:
16 contour interfaces, “stitching” zones, etc. Evaluations of rendered surface quality and detail resolution
17 are required as are evaluations of mechanical properties that probe a variety of failure modes such as
18 tensile, fatigue, and toughness. In cases where qualification methodologies exist within internal
19 corporate policies, negotiation is generally required to strike an appropriate balance for AM process
20 qualification intent.
21 The range of realized process control methodologies is broad across this sector with limited degrees of
22 consensus on what is most effective and minimally required to achieve the expected part reliability. The
23 fixed process control documentation (PCD) is generally the core basis of control across the sector. These
24 PCD approaches most always utilize a minimalistic, single-point process witness methodology to confirm
25 process/part acceptance. Though required by some SDO production standards as well as the NASA-STD-
26 6030, the implementation and acceptance of genuine statistical process control (SPC) methodologies
27 remains uncommon. Where SPC is implemented, it is often segregated from actual part acceptance and
28 used for “engineering information” only. This remains a significant standardization challenge. Even
29 within the SPC implementation, there are differing opinions about whether SPC should apply to machine
30 key process variables, the outcome of the final material performance, or both. It is not clear that
31 standardizing SPC implementation in AM has the priority it needs withing the SDO community.
32  Machine/Equipment - Equipment control
33 AM equipment control has recently made some modest gains in the standardization process within the
34 SDOs; however, a consistent and standardized implementation of AM machine and equipment control
35 remains elusive in this sector. The approach and extent to how machines and their facility environments
36 are controlled varies greatly from instance to instance, often based on past practices or level of
37 understanding of AM at a given entity. The NASA-STD-6033 provides a broad description of expectations
38 of AM machine and facility control, primarily in the requirement of a plan for such control along with
39 key aspects of controls expected to be addressed by the control plan. An SDO standard that attempts to
1 define the minimum aspects of AM machine and facility control either does not yet exist or has failed to
2 achieve consensus within this sector.
3 While there are unique aspects to AM equipment and facilities that require specific care and control,
4 from a regulatory perspective there have not been any expectations of unique regulatory activities
5 needed in this regard in the sector. The regulatory acknowledgement that such controls need to be
6 defined and exist is considered adequate. Standards to assists in the implementation of machine and
7 facility controls would make the regulatory aspect of accessing the adequacy of such controls easier and
8 more consistent.
9  Part/Devices – Part classifications, if used, and what they affect in Q&C, Design, Part and/or
10 Product Qualification, Difference in regulatory requirements by product type, Technical Data
11 Package expectations
12 The intent and implementation of part classifications remains very inconsistent across the sector. NASA-
13 STD-6030 has provided a system of part classification that ranks parts first by consequence of failure
14 into three primary classes, high to low (A, B, C), and sub-classes (1-4) based on risk criteria within classes
15 A and B. Within the NASA spaceflight portion of the sector, NASA pushes hard for the use of these
16 standard classifications, but there is limited consensus. The reality is that within any regulated sector,
17 AM parts are likely to be pressed into a variety of service conditions that vary in criticality, usually based
18 on safety or perhaps on liability or expense. Though some limited activity has occurred recently in the
19 SDO community regarding standardizing AM part classifications, the vast majority of standards do not
20 invoke the concept of AM part classification. As a general rule, SDO standards are written to a “lowest-
21 common-denominator” that will pass a committee vote. When combined with the absence of
22 classifications to segregate levels of control, the SDO products end up in a state considered inadequate
23 for critical applications within the sector due to lack of specific controls that would need to be added in
24 through extensive customer agreements in the purchase contract.
25  Personnel/Suppliers - Personnel training
26 Training of personnel currently has minimal structure to it in this sector, even though proper training is a
27 prerequisite for ensuring process control. While there are efforts underway to help train engineers and
28 technicians in the variety of jobs related to AM, the predominant means of training continues to be on
29 the job experience anchored by training offered by AM equipment manufacturers. The NASA
30 requirements acknowledge the evolving training environment and recognize that many providers will
31 prefer to have their staff internally trained. The requirement for training is that a formal method exist
32 with documentation and that staff have clear understanding of what aspects of the AM process are
33 covered by their training credentials.
34  Framework for enabling AM suppliers
35 In the civil spaceflight sector, there continues to be a steady move toward the adoption of external AM
36 suppliers. For this discussion, the scenario of an AM supplier exists when the producer of the AM parts is
1 separate from the design entity and/or the “cognizant engineering organization.” This creates a
2 challenge regarding establishing requisite engineering equivalence of AM materials and processes
3 between the design and production entities so that part performance is assured to meet the
4 assumptions used in design. The NASA standards do not specify how external AM suppliers are qualified
5 or enabled. Rather, they hold that the foundational process control and required material engineering
6 equivalency is established and maintained through equipment and facility controls, qualification of
7 materials and processes, statistical process controls, and so forth. In other words, it is incumbent on the
8 cognizant engineering organization to ensure the supplier process is in full compliance with the base
9 requirements and that the engineering equivalency of the material performance is ensured.
10 2.3.3.1.2 Civil Aviation Industry

11
12 Roadmap Version 2 “Aerospace” Text below (some updating has been done but this is a work in
13 progress while the team looks at alignment between civil aviation and the civil/commercial spaceflight
14 sector write-up above)
15
16 The aerospace industry is different from other industries in that space-based parts typically cannot be
17 recalled and parts must withstand space environments. Human space flight poses unique safety
18 concerns and therefore requires more stringent flight qualification than other industries. The intended
19 use of the product dictates the rigor of the material and part qualification categories.
20 Most flight components will be metal structural/flight components such as titanium or aluminum, so this
21 should be a priority for standards development. ULTEMTM 9085 is also being used for non-structural
22 flight parts. Many aerospace industry components will include integration of mixed materials.
23 Materials
24 Typical industry practice is that precursor materials are “certified” (qualified) and/or verified, though
25 FAA only certifies final products. Material certification standards in existence can be used as is, with
26 modifications, or as a point of departure for new standards for AM materials. Normally, material
27 suppliers certify their materials to these standards and the buyers verify the certification. These
28 certifications are to be included in the data package required for qualification and certification of the
29 AM processed part. AM material properties are highly dependent on process/machine variables as well
30 as post-processing.
31 Parts/Products
32 Parts/products are qualified and verified. The part qualification process achieves a product certification,
33 which ensures the product meets all technical requirements. Part qualification is typically governed by
34 program/customer technical requirements and standards.
35 Product verification requirements define activities to minimize risk and certify that the delivered system
36 or product satisfies hardware, software, and system requirements, as qualified. Each product goes
37 through verification, also known as product acceptance, to ensure requirements are met during or after
1 the build process by performing an inspection, demonstration, analysis, or test. These verification
2 activities are often performed to standards (e.g., ASTM, etc.). Product verification may include 1st article
3 inspection to demonstrate the suitability of 1st time use by performing additional inspection, test, and
4 demonstration activities.
6  API STD 20S, Additively Manufactured Metallic Components for Use in the Petroleum and
7 Natural Gas Industries, First Edition (10/1/2021)
8  API STD 20T, Additively Manufactured Polymer-Based Components for Use in the Petroleum and
9 Natural Gas Industries First Edition (8/1/2022)
10  ASTM F3572-22, Standard Practice for Additive Manufacturing – General Principles – Part
11 Classifications for Additive Manufactured Parts Used in Aviation
12  AWS D17.1/D17.1M:2017-AMD1, Specification for Fusion Welding of Aerospace Applications
14 Manufacturing
15  NASA-STD-6030, Additive Manufacturing Requirements for Spaceflight Systems
16 In-Development Standards
18 Processing - Additively Manufactured Spaceflight Hardware by Laser Beam Powder Bed Fusion In
19 Metals
22  ASTM WK70164, Practice for Additive Manufacturing -- Finished Part Properties -- Standard Practice
23 for Assigning Part Classifications for Metallic Materials
24  ASTM WK73239, Classification for Additive Manufacturing --Qualification principles -- Classification
25 of part properties for additive manufacturing of polymer parts
26  ASTM WK75329, Practice for Nondestructive Testing (NDT), Part Quality, and Acceptability Levels of
27 Additively Manufactured Laser Based Powder Bed Fusion Aerospace Components
28 Gap QC2: AM Part Classification System for Consistent Qualification Standards. A part classification
29 system is used to describe the level of risk associated with a part and may therefore be used as a metric
30 to gauge appropriate qualification requirements. A common classification system for AM parts by
31 industry sector is needed to provide consistent evaluation criteria for AM part risk. This should include a
32 definition of criticality levels. Consistent risk criteria provide the basis for consistent expectations and
33 levels of qualification rigor. Examples of classification systems can be found in NASA’s NASA-STD-6030,
34 Additive Manufacturing Requirements for Spaceflight Systems, and the AWS D20.1/D20.1M:2019
35 Specification for Fabrication of Metal Components using Additive Manufacturing, which utilizes the part
36 classification system identified in AWS D17.1/D17.1M:2017-AMD1, Specification for Fusion Welding of
37 Aerospace Applications. Any industry requiring rigorous AM part qualification and system certification
38 would benefit from a common part classification system.
3 that AM CoE Projects 1804/1907 (WK65937, WK65929) address AMSC gap QC2.
4 Recommendation: A technical report describing existing classification systems for AM parts would be
5 useful. It could include the recommended minimum process and part qualification requirements
6 commensurate with part risk for each classification level.
8 Organization: ASTM F42/ISO TC 261, AWS, DoD, FAA, NASA, SAE

11 Repair; ☐Data


21 ☐New
22 V3 Update: Published and in-development standards since the last roadmap iteration are noted. This
23 includes ASTM F3572 which we understand will be referenced by the European Union Aviation Safety
24 Agency (EASA).
25
26 Processes or Procedures
27 Each implementation of an AM process requires qualification prior to use in most aerospace

28 applications. An implementation of an AM process may be referred to as an AM procedure, such as the
29 case of the AWS D20 standard, which inherits its terminology from AWS D17.1 regarding welding
30 procedure qualification. Process or procedure qualification is essential to ensure the fundamental
31 integrity of material produced by any given AM machine under a fully defined and fixed process. There is
1 currently no consensus definition for the qualification of additive processes. This lack of standard
2 definition presents a risk to the additive user community in aerospace by introducing significant
3 variation in the evaluations included in the qualification methodology. This renders process qualification
4 largely vendor-specific, and requires a case-by-case evaluation of the qualification methodology for any
5 given set of requirements. A vendor’s assertion of qualified additive processes does not, in and of itself,
6 provide meaning if not presented with the specifics of the qualification methodology. A few common
7 examples of variations in the additive process/procedure qualification methodology include the degree
8 of internal material quality assessment (microstructure, porosity, lack of fusion, etc.), the degree of
9 mechanical property evaluation (tensile, fatigue, fracture toughness, etc.), degree of evaluation in the
10 quality of surfaces and rendered details, and the extent of build quality evaluation throughout the
11 available build area/volume.
12 The definition of the actual process or procedure being qualified often lacks consistency. For example,
13 feedstock controls and thermal processes may, or may not, be included in the definition. Such precursor
14 and successor steps to the base AM process are critical if the process qualification is intended to
15 guarantee fundamental material performance.
16 Different approaches also exist in the aerospace industry regarding the distinction between the
17 qualification of additive parts and the foundational processes/procedures. A few examples are listed
18 below:
19 NASA: The NASA document, NASA-STD-6030, Additive Manufacturing Requirements for Spaceflight
20 System separates the qualification of the foundational PBF-L process from the qualification of an
21 additive part, which is considered a geometry-specific implementation of the qualified process. The part
22 then requires its own part-specific qualifications to demonstrate successful implementation of the
23 process.
24 AWS: By contrast, the AWS D20.1 standard requires the qualification of the AM procedure used to
25 produce a component, where the qualified procedure must contain all variables required to fabricate
26 the component, such as the build model, feedstock and build platform characteristics, AM machine
27 variables, build environment requirements, build parameters, and component post-processing. In this
28 scenario, the AM procedure is part-specific and is qualified through the fabrication and evaluation of
29 test articles.
30 SAE: The SAE AMS AM-M (metallic) specifications under development are hierarchical and define the
31 requirements and establish controls for a material process combination. They are based on a material
32 specification, including material requirements. Each material specification is linked to a separate process
33 and feedstock specifications, as well as a feedstock process specification. The SAE AMS AM-P (polymer)
34 specifications are similar with a base material specification that is linked to a process specification. In
35 addition, there are separate detailed material specifications that include the specification minimum
36 values for specific material/process combinations.
37 Personnel
1 Personnel are “certified.” Currently, operator certification is through on the job training coupled with
2 OEM-provided training (classroom and hands on experience) specific to particular machines/equipment.
3 Procedures may be written to document how personnel certifications are accomplished. Some
4 certifications include levels of certification that determine the specific activities/operations that an
5 operator can perform, such as product acceptance, equipment maintenance, or certification of other
6 operators. Future needs may call for formal personnel certification by process, or process and material,
7 as well as for specific machines. AWS D20.1 has a section on qualification of AM machine operators and
8 operator certifications are described in the NASA standard for laser powder bed fusion for AM. ASTM
9 offers a general AM certification and may also be looking at other certifications. The aerospace and
10 defense industries are aligned in their approach to personnel certification, so the gap identified in the
11 Defense Industry section 2.3.3.4 below is applicable.
12 AM Equipment
13 AM equipment is calibrated and/or certified by the OEM or aerospace industry company that purchases
14 the equipment per certification and/or calibration procedures. Some companies refer to calibration as
15 certification. See section 2.2.2.3 and gap PC2 on machine calibration and preventative maintenance.
16 Adverse machine environmental condition standards are needed so the build environment can be
17 compared to the as specified parameters for environmental control through methods such as chamber
18 gas, temperature, and pressure monitoring. Adverse machine environmental conditions: effect on
19 component quality is addressed in section 2.2.2.6 and gap PC6 of this roadmap.
20 The aerospace industry needs additively manufactured physical calibration standards for NDE. Those
21 standards are covered in the NDE section of this roadmap.
22 AM Drawing and Model Standards
23 It is anticipated that the aerospace industry will adopt industry standards for drawings and for DSR4 and
24 DSR6 (no drawing) models. It is anticipated that only models will be needed in the future and the models
25 will cover all aspects currently in the drawings and will include things like x,y,z orientation, growth
26 direction, etc. Drawing and model standards are needed so the as-built models can be compared to the
27 as-designed models for product acceptance through inspection methods such as 3D scanning and CT
28 scanning. Gaps for drawing and model standards are addressed in the Design section of this roadmap.
29 2.3.3.2 Automotive Industry
30 This industry sector may be at a more nascent stage in its use of AM. This is a placeholder should
31 representatives of this industry wish to provide content regarding their approach to Q&C.
32 The process control WG has noted this nearly published standard: ISO/ASTM DIS 52945, Additive
33 manufacturing for automotive — Qualification principles — Generic machine evaluation and
34 specification of key performance indicators for PBF-LB/M processes.
35
1 Request to Public Reviewers: AMSC members welcome suggestions and feedback on the
2 considerations and standards and R&D needs for this sector.
3
4 2.3.3.3 Construction Industry
5 This industry sector may be at a more nascent stage in its use of AM. This is a placeholder should
6 representatives of this industry wish to provide content regarding their approach to Q&C.
8 considerations and standards and R&D needs for this sector.
9 2.3.3.4 Defense Industry
10 The defense industry does not have a certification program like the FAA or NASA as a standard
11 requirement across the industry. So, the certification and qualification of material, machine, process,
12 and build is not exactly the same from company to company or even across the defense agencies. In
13 some ways qualification of a part for a Defense Acquisition remains very similar to standard parts.
14 Anything going onto a ship, aircraft, submarine, ground vehicle, or otherwise employed by our military
15 forces goes through varying levels of Q&C prior to deployment. Even commercial or non-developmental
16 items have to be tested to make sure they meet the technical and performance requirements
17 demanded by the platform. Depending on the rigor required for the part usage, it is evaluated at a
18 component and system level. Rigor is dependent on class classification of parts. A common evaluation
19 for AM and non-AM parts are class classification. Different groups rate their class classification
20 differently, but they all evaluate an overall understanding of application, characterizing the risk (from
21 low to high) and the probability of failure. For example, any new aircraft undergoes rigorous
22 developmental and operational testing before fielding, no matter the origin of the item on the platform.
23 Components are tested individually, as part of a system, perhaps integrated into an avionics suite or
24 green weight airframe as appropriate, then flight tested as appropriate before a decision is made for full
25 rate production. This happens regardless of how that part is manufactured.
26 As industry standards and specification are created, groups are starting to add them into their standard
27 process, but it is slow for two reasons. One, groups have already created and started to qualify to their
28 own internal specs. Two, it is hard to find suppliers that can meet the requirements of the industry
29 standards and specifications currently. There is a movement towards them, but it is slow. Future state
30 may have some groups heavily using them and others remaining primarily only with their internal specs.
31 While standards are being developed for many applications, there is still a need for defense industry
32 specifications to capture unique requirements and materials for the military.
33 Different groups leverage different allowable23 tools and requirements. Both MMPDS and CMH-17 are
34 developing a framework of methodologies and policies for additive processes. These frameworks as well
23
See discussion of terminology (“material allowable” and “design value”) in section 2.2.4.1.1 of this roadmap.
1 as internally developed allowables are being used. Some groups go beyond traditional allowable
2 recommendations because of the variability of the AM process; some qualify by machine-to-machine
3 and others go to a wide variety of suppliers to get a larger variability.
4 The U.S. Department of Defense (DoD), through its Joint Defense Manufacturing Council released the
5 Department of Defense Additive Manufacturing Strategy (January 2021). DoD is working with the
6 Defense Logistics Agency (DLA), and the Office of Safety & Defense (OSD) on a Joint AM Acceptability
7 (JAMA III) initiative. The JAMA project is the result of the DoD Instruction (DoDI) 5000.93, Use of
8 Additive Manufacturing in the DoD, which became effective on 10 June 2021. The goal of JAMA III is to
9 “Generate frameworks for a common AM part qualification process for the DoD and industry
10 stakeholders to facilitate commercial integration of AM vendors into the DoD supply chain, while
11 maintaining quality standards.”24
12 DLA has expressed strong support for use of AM for acquisition, particularly in manufacturing decades old legacy
13 parts that no longer have a supporting industrial base. However, the technical data associated with these parts is
14 usually found as 2D blueprints, thus requiring a conversion to 3D models. In addition to the added cost of this
15 process, current methods of converting to 3D data introduces errors that increase the complexity of the
16 certification process.
17 2.3.3.4.1 Technical Data Package (TDP)
18 A TDP is defined in MIL-STD-31000B, Military Standard: Technical Data Package (TDP) (31-OCT-2018),
19 section 3.1.40 as:
20 The authoritative technical description of an item. This technical description supports the
21 acquisition, production, inspection, engineering, and logistics support of the item. The
22 description defines the required design configuration and/or performance requirements, and
23 procedures required to ensure adequacy of item performance. It consists of applicable technical
24 data such as models, engineering design data, associated lists, specifications, standards,
25 performance requirements, quality assurance provisions, software documentation and
26 packaging details.
27 A TDP is used to contract out for the procurement of parts and components for DoD assets. The goal of
28 developing a TDP is to encompass all the necessary data to allow for competitive bidding for parts to be
29 additively manufactured, while ensuring that there is enough detail and information within the TDP to
30 produce the same exact part with the same properties that fall within the specified tolerances and
31 requirements from any vendor. The development of a common TDP will not be possible without
32 specifications and standards that can be invoked to guide the manufacturing process.
24
Presentation slides from January 18, 2023 JAMA III AM Standards & Specifications Discussion. Contact
[email protected] for more information.
1 As a common TDP is developed there is a push for an increased awareness of digital thread for all parts,
2 but especially AM parts, capturing data from design, analysis, build files, manufacturing plans, etc. One
3 of the biggest hurdles in this area is software capability.
4 There are a number of cooperative research & development agreements (CRADAs) between defense
5 agencies and defense contractors to help align and build a common understanding, and to bring both
6 group knowledge of AM up and have the same understanding and requirements for TDPs.
7 In order to achieve the goal of producing accurate parts repeatedly, a certified TDP format must be
8 developed and proven. This certified TDP format will increase certainty of acquiring repeatedly accurate
9 components as well as providing the logistics communities the ability to successfully order additively
10 manufactured components in the future. Navy efforts have included developing a part- and process-
11 agnostic TDP format that will aid in the overall process for manufacturing components via additive
12 manufacturing (regardless of criticality). It is understood that there are a number of challenges
13 associated with developing a process-agnostic TDP. See the discussion in section 2.1.5, Design
14 Documentation, of this roadmap and gap DE17 on data packages.
15 Neutral build files are the desired end state for build files that can be ported between different types of
16 machines/processes. See also gap DE20 on neutral build file format.
17 2.3.3.4.2 Harmonizing Q&C Terminology for Process Parameters
18 Each machine manufacturer has their own set of terms that they use to describe the processing
19 parameters within their machine. Often, two identical process parameters will have different terms
20 associated with that parameter if you directly compare two machines made by different manufacturers.

23 Manufacturing
24  ISO/ASTM 52900:2021, Additive Manufacturing - General Principles - Fundamentals and
25 vocabulary
27 In-Development Standards
29 Processing - Additively Manufactured Spaceflight Hardware by Laser Beam Powder Bed Fusion
30 In Metals
33
34 Gap QC3: Harmonizing Q&C Terminology for Process Parameters. In order to enable full understanding
35 of the given processes and to include this type of information in a process-agnostic TDP, and for
1 purposes of qualification and/or certification, there must be standardization of process parameter
2 terminology across machine manufacturers.
5 that AM CoE Projects 1804/1907 (WK65937, WK65929) address AMSC gap QC3.
6 Recommendation: Develop standardized terminology for process parameters for use across all AM
7 equipment. Incorporate terms as appropriate into ISO/ASTM 52900:2021, Additive manufacturing -
8 General principles – Fundamentals and Vocabulary. See also gap PC5 on parameter control.
9 Priority: ☐ High; ☒Medium; ☐Low
10 Organization: ASTM F42/ISO TC 261 JG 51, AWS D20, SAE AMS-AM, IEEE-ISTO PWG

13 Repair; ☐Data


22 V3 Status of Progress: ☒Green; ☐Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☐Closed; ☐
23 New
25 2.3.3.4.3 Process Approval for DoD-procured Parts
26 For a lot of defense agencies and contractors, before a vendor can supply a component, that vendor
27 must be qualified to manufacture that part with an AM specific process, machine, and sometimes serial
28 number (S/N) of machine. Q&C necessarily is applied to the actual manufacturer, not a third party that
29 may act as a middleman or distributor. For every Source Approval Request (SAR) package, a vendor must
30 demonstrate manufacturing standards, first article test, and requisite performance testing within their
1 capacity to do so. The manufacturing methods for the part must be specified by the vendor along with
2 any other critical processes through the end of post-processing. This would include all of the parameters
3 needed to qualify or certify the final part. Depending on the use, the defense agency often requires
4 additional environmental testing, be it flight, seaworthiness, or electromagnetic compatibility. As AM
5 continues to rapidly mature, especially in the near term, it may be challenging to keep up with the pace.
6 Therefore, industry and government will have to work together to understand the nuances of different
7 AM methods, and what needs to be qualified, tested, and demonstrated by an AM produced
8 component. ASTM has begun to populate the landscape with some standards, such as ASTM B962-17,
9 Standard Test Methods for Density of Compacted or Sintered Powder Metallurgy (PM) Products Using
10 Archimedes’ Principle, which has already undergone several revisions.
11 Certification of parts is governed by regulations for criticality and safety criteria based on the
12 application. Responsibility for certification of the components for the intended application needs to be
13 agreed to between the customer (DoD) and the supplier/manufacturer of the AM component.
14 Identified published standards include: ASTM B962-17 noted above, ASTM E384-22, Standard Test
15 Method for Microindentation Hardness of Materials, and ASTM F3213-17, Standard for Additive
16 Manufacturing - Finished Part Properties - Standard Specification for Cobalt-28 Chromium-6
17 Molybdenum via Powder Bed Fusion.
18 Gap QC4: Process Approval for DoD-procured Parts. As multiple methods of AM continue to mature,
19 and new AM techniques are introduced, the government will need to fully understand the ramifications
20 of each of these techniques, of what they are capable, and how certain AM procedures might lend
21 themselves to some classes of parts and not others. Thus, not only must the government understand the
22 differences, but how they should be assessed and tested, and what additional checks must be made on
23 the end product before it can be qualified for use in a military platform. High pressures, temperatures,
24 and other contained environments could impact the performance or life of safety-critical parts in ways
25 that are not understood. More research is required to determine the delta between traditional and AM
26 methods.
29 Recommendation: Starting with the most mature technologies, such as laser powder bed, there is a
30 need to develop standards that assess required checks for levels of criticality and safety as part of the
31 DoD procurement process. DoD should participate in the development of such standards and specify the
32 certification requirements needed.
33 Priority: ☐ High; ☒Medium; ☐Low
34 Organization: ASME, ASTM F42/ISO TC 261, DoD, Industry, SAE, Service SYSCOMS
3 Repair; ☐Data
4 Sectors: ☐All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☒Defense; ☐Electronics;


12 V3 Status of Progress: ☐Green; ☒Yellow; ☐Red; ☐Not Started; ☐Unknown; ☐Withdrawn; ☐Closed; ☐
13 New

15
16 2.3.3.4.4 Machine Operator Training and Qualification
17 Training and qualification are not standardized across the defense industry, since many AM processes do
18 not have standards to address them, and many users rely on internal requirements for training and
19 qualification. All potential users of an AM machine, auxiliary equipment, and related software need to
20 undergo appropriate training for their responsible areas. There may be different levels of operator
21 training required. AM machine operator competencies may include: feedstock material storage, safety,
22 and setup; machine calibration and maintenance; machine setup and operation; build cycle monitoring;
23 and interruption recovery. Re-training at some frequency also may be required. An internal training
24 database should be maintained and used to reflect operator competencies on each responsibility and to
25 ensure any changes in machine operation are accounted for in training updates. Periodic audits may be
26 used to validate that operation steps are being followed.
28 ISO/ASTM 52942:2020 Additive manufacturing — Qualification principles — Qualifying machine

29 operators of laser metal powder bed fusion machines and equipment used in aerospace applications
30 (aka ASTM F3471-20, was ASTM WK73170)
31
32 The SAE 7000 series also addresses training. There is also SAE ARP 1962B-2019, Training and Approval of
33 Heat-Treating Personnel, though it is not AM-specific.
1 AWS D20.1 contains a Clause 6 on requirements for AM machine operator performance qualification. It
2 requires that the AM machine operator undergo training, written examination, practical examination,
3 and a build demonstration in order to become qualified.
4 Standards in Development
7  ASTM WK72458 New Specification for Additive Manufacturing -- Qualification principles --
8 Qualification of coordinators for metallic parts production
9  ISO/ASTM DIS 52926-1, Additive manufacturing of metals — Qualification principles — Part 1:
10 General qualification of operators (see also ASTM WK71375 /F3500)
12 Qualification of operators for PBF-LB (see also ASTM F3466)
14 Qualification of operators for PBF-EB (see also ASTM F3467)
16 Qualification of operators for DED-LB (see also ASTM WK71378 / F3468)
18 Qualification of operators for DED-Arc (see also ASTM WK71379 / F3469)
19 Underwriters Laboratories (UL), in cooperation with industry SMEs, for example, has developed a multi-
20 tiered program covering comprehensive introductory knowledge, technical and business competencies,
21 and hands-on application-based learning. The University of Louisville is host to UL’s advanced hands-on
22 training focused on metals. The program emphasizes the safe implementation of AM and in
23 collaboration with Tooling-U SME, includes the industry’s first Professional Certification. ASME is also
24 exploring machine operator training curriculum.
25 Gap QC5: Machine Operator Training and Qualification. There is a need for standards or guidelines
26 outlining AM training requirements. AM training programs include but are not limited to those offered
27 by OEMs and other third-party organizations.
30 Recommendation: Develop AM operator training and qualification standards or guidelines. The

31 provision of equipment-specific training is the purview of OEMs. At a high level, SDO training materials
32 are aimed at covering the various AM materials and processes available in the market and are
33 performance based to ensure consistent AM part quality. Develop additional standards for artisanal
34 levels of competency and experience, delineating an individual’s expertise in the field or subsets of the
35 AM field.
1 Organization: NASA, SAE, AWS, OEMs, UL, ASTM F42/ISO TC 261, AAMI

4 Repair; ☐Data


14 New
16 In the specific case of DoD, consideration should be given to establishing a sub-specialty code for AM.
17 Concerns also include training for enlisted personnel, training tailored for specific AM machines (or
18 categories thereof), and materials as needed to complete mission requirements. Such a training course
19 should include:
20 Qualification
21  Software and CAD file preparation

22  Knowledge of machine and material limits
23  Machine calibration and maintenance (whether performed by the operator/vendor or the
24 machine OEM)
25  Proper material handling
26  Proper waste recycling/containment
27  Monitoring of the fabrication process
28  Part separation from the build plate
29  Post-processing (if performed by the operator/vendor)
30  Inspection/testing (if performed by the operator/vendor)
31  Safety precautions for AM machine and material use
32 Certification
1  Reading all applicable standards and supplements on AM certification (when developed)
2  Testing in accordance to these standards
3  Completing an AM performance qualification test at an accredited test facility
4  Submitting a completed application for certification
5  Submitting maintenance of AM certification prior to expiration, which verifies that all the AM
6 processes were used
7 2.3.3.4.5 Material Certification
8 Precursor materials will have to meet certain specified requirements in order to be used for AM
9 processes. The current specifications and standards along with the gaps that exist for precursor
10 materials can be found in the Precursor Materials section of this document. Due to the nature of how
11 parts are made, and how differences in orientation, build plate location, or AM processes are being
12 used, the buildup of stresses and resulting material properties may vary between machines and build
13 plates. Responsibility for verification and testing of the material properties (including test
14 coupons/artifacts) and for compliance with the performance requirements of the components needs to
15 be agreed to between the customer (DoD) and the supplier/manufacturer of the AM component.
16 2.3.3.4.6 Qualification and Certification Testing of Final Parts
17 As previously mentioned, the certification of final parts for use will be a significantly more difficult
18 process for AM components as a result of the lack of allowables for AM materials and the lack of
19 consistency between AM parts made via different AM processes and even parts made via the same
20 process using different equipment. The challenges associated with the gaps in standards and
21 specifications for finished materials are addressed in the Finished Material Properties section of this
22 document.
23 2.3.3.5 Electronics and Electrical Products Industry

24
25 This industry focuses on producing electrified products for use in residential, commercial, and industrial
26 applications including homes, retail/hospitality establishments, public spaces, offices, and
27 factories/warehouses. The category can be subdivided into indoor and/or outdoor applications.
28 Furthermore, the category is sometimes further divided into home and/or professional applications.
29 Typically, such products are qualified and verified as part of a product certification to demonstrate
30 compliance with recognized product safety and performance standards. Also, since these products may
31 become permanent or semi-permanent elements of built structures, or structures themselves, they are
32 required to comply with installation and use requirements of relevant electrical or building codes and
33 regulations. Some electronic components are also used in other industries covered by other sections of
34 this chapter. This section is not covering Q&C requirements in those other industries.
35 Use of Additive Manufacturing
1 AM has been in regular use to produce prototypes for physical examination, fit/function analysis and
2 test sample purposes. AM has also been used to produce tooling or jigs for mechanical product
3 manufacturing purposes.
4 Previously, there has been an industry shift toward an interest in using AM to produce mechanical parts
5 for targeting proof-of-concept, prototype, and volume applications. Recently a new industry started to
6 evolve which additively creates traditional electronic printed circuit board (PCB) assemblies with either
7 formed and/or unpackaged/prepackaged components, known as Additively Manufactured Electronics
8 (AME). These substrates merge component and electrical data from mechanical and electrical CAD
9 systems. For example, a wire wound inductor shape is created in MCAD, loaded into an ECAD PCB
10 layout, given electrical properties, and embedded into the schematic and layout, then additively formed
11 within the circuit board. This is also including AM created semiconductor devices. Functionally-graded
12 materials for both dielectrics and conductors are being introduced which are compatible with AM
13 processes to supplant traditional PCB materials, for example nano particle inks for printing methods.
14 Multiple trade organizations and academic research institutions have begun to examine the advantages
15 of AM and are promoting its adoption for these applications. The AME assemblies cross into all
16 application domains.
17 Qualification and Certification
18 Since electrical and electronics products are typically required to be qualified and certified to existing
19 product safety and performance standards, the use of an equivalent AM built component or full product
20 should also conform to the practice of standards. Many of the applicable standards contain type-test
21 based evaluation criteria which allow parts to be qualified based on their physical and electrical
22 properties. Accordingly, type-testing of AM parts is an option. These standards also contain prescriptive
23 requirements based on historical data. The application of these prescriptive requirements could require
24 reconsideration of applicability to parts fabricated by AM. Certifications generally require ongoing
25 verification in production to ensure consistency between production parts and parts subject to
26 prescriptive and/or type-test qualification. Variations in parts due to different AM processes or parts
27 made using different equipment must be addressed. To address some of these variables, standards have
28 been developed for polymeric materials as described in the Identified Guidance Documents section of
29 this document.
30 Currently there are no industry qualification or certification standards for AME technology. A significant
31 amount of investigation and testing is required due to the significant physical difference between
32 existing PCB and PCB assemblies, which use copper plated mechanically drilled, or laser ablated, holes to
33 connect between layers of horizontally etched traces, versus additively created X,Y,Z interconnect
34 structures.
35 Since products in this category often also need to conform to installation requirements contained in
36 codes and regulations, consideration must be given to the application of AM parts in this context. Such
37 codes and regulations can focus on criteria such as fire resistance, smoke generation, structural integrity
38 and toxicity. As AM and AME mature as methods of manufacturing general purpose electronic and
1 electrical products, there is a need to understand the possible ramifications on compliance with product
2 safety/performance standards and regulations. An understanding of differences between traditional
3 manufacturing techniques and AM regarding end-product performance is needed.
4 Published Standards: None identified
6 The following new IPC projects are planned to start in 3Q2023 and be released by 4Q2025.
7  IPC-6905 Qualification and Performance Specification for Additively Manufactured Electronics

8 (AME)
9  IPC-6911 Acceptability of Additively Manufactured Electronics (AME)
10  IPC-B Additively Manufactured Electronics (AME) Coupons
11
12 New Gap QC17: Additively Manufactured Electronics (AME). No qualification, acceptability, and coupon
13 standards currently exist for 3D AME substrates where traditional AM electrically functional components
14 are created within an electrical PCB-like substrate. See also roadmap section 2.6.2.9 on AME data
15 transfer format and gap DA7.
17 R&D Expectations: Reliability and qualification standards with validating research is required for all
18 industries.
19 Recommendation: Develop standards for AME technology.
21 Organization(s): IPC, IEC

24 Repair; ☐Data
25 Sectors: ☒All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☒Electronics;

3 Current Alternative: The current alternative is to manufacture AME substrates by extrapolating

4 reliability and qualification requirements from existing IPC printed circuit board specifications and test
5 methods.
7 ☒New
8 2.3.3.6 Energy Sector

9
10 2.3.3.6.1 Nuclear Industry
11
12 Introduction
13 The U.S. Nuclear Sector is similar to other energy and industry sectors in its struggles with qualification
14 and certification of components produced via additive manufacturing (AM). Specific guidance on the use
15 of AM is lacking and incohesive as defined by the various competing AM industry standards writing
16 bodies. From the U.S. Department of Energy’s (DOE) Office of Nuclear Energy (NE): Advanced Materials
17 and Manufacturing Technologies (AMMT) Program:
18
19 The U.S. nuclear industry is undergoing a new renaissance. Traditional large-scale reactors face
20 economic challenges often too overwhelming to advance to a construction phase or, if they do, cost
21 overruns during construction that warrant cancelling any new builds. New small modular reactors
22 (SMRs) and microreactors offer a trade-off of cost and power output. The realization of this, and the
23 need for rapidly increased deployments of nuclear power, are in the national spotlight. Traditional
24 methodologies of manufacturing and construction are now being revolutionized by AM. AM offers new
25 complex, geometric builds in various materials and alloys which enables advanced and optimized
26 designs not previously possible. To supplement this renaissance, the acceptance and certification of AM
27 components must also be a priority. Technological advances allow for a digitally certified component
28 build that can assure that quality aspects are met. These advances are critical as is a paradigm shift from
29 a traditional certification methodology to one that rightly embraces AM. That said, there remain some
30 gaps that must be addressed to fully exploit the use of AM, as further discussed in the gaps section
31 below.
1 Industry Governance
2 The U.S. nuclear energy industry (i.e., entities that use nuclear fusion/fission to produce electricity) is
3 governed, regulated, and/or licensed by a combination of government agencies including the Nuclear
4 Regulatory Commission (NRC), Department of Defense (DOD), National Aeronautics and Space
5 Administration (NASA), and the Department of Energy (DOE). According to the U.S. General Accounting
6 Office (GAO), DOE seeks to advance nuclear energy through research and development activities. It is
7 also responsible for siting, building, and operating a geologic repository to dispose of high-level nuclear
8 waste.
9 The NRC licenses and oversees the safe operation and security of commercial nuclear power plants,
10 research reactors, and other nuclear production and utilization facilities. The NRC, in conjunction with
11 state and local regulatory agencies, is responsible for all U.S. commercial nuclear plants (92 operational
12 power reactors), research and test reactors (31 operational), space reactors, private isotope facilities,
13 and the DOD fleet of naval reactors. Nuclear fuels in the U.S. are also regulated and licensed by the NRC
14 and include additional regulatory processes defined in 10CFR70 and others. NASA works in conjunction
15 with the NRC and DOE in researching, overseeing, and regulating U.S. nuclear space applications.
16 The DOE serves much of the research role for the public and private nuclear industry while also
17 regulating research reactors and isotope production facilities residing on DOE sites, namely at national
18 laboratories. Examples of these include the isotope research and production facilities and the High-flux
19 Isotope Reactor (HFIR) residing at Oak Ridge National Laboratory (ORNL) and the Advanced Test Reactor
20 at Idaho National Laboratory (INL). There are a total of approximately six operating reactors and
21 numerous nuclear facilities under DOE oversight and regulation.
22 The DOE National Nuclear Security Agency (NNSA) is also responsible, in conjunction with the DOD, for
23 the nuclear weapons stockpile readiness, production, and disposition. The Naval Nuclear Propulsion
24 Program provides militarily effective nuclear propulsion plants and ensures their safe, reliable, and long-
25 lived operation. NNSA’s Naval Reactors Program provides the design, development, and operational
26 support required to provide militarily effective nuclear propulsion plants and ensures their safe, reliable
27 and long-lived operation.
28 Various departments within the DOE are involved in material and qualification research into general
29 additive manufacturing including the Advanced Materials and Manufacturing Technology Office
30 (AMMTO) and the Industrial Efficiency and Decarbonization Office (IEDO) taking over responsibilities for
31 the Advanced Manufacturing Office (AMO). For nuclear applications, the DOE’s Office of Reactor Fleet
32 and Advanced Reactor Deployment has established the AMMT program, specifically focused on material
33 research and qualification for nuclear applications. Both of these DOE efforts include participation by
34 research entities, faculty, resources, and personnel from U.S. academia and the DOE national
35 laboratories.
36 Nuclear part fabrication, qualification, and certification processes are unique. The highest levels of
37 quality, material specifications, and requirements are applied. The parts must be able to withstand and
1 perform their safety functions while being exposed to potentially long-term and high levels of
2 radioactivity. To support these safety functions, additional specifications and testing of nuclear parts are
3 performed to ensure the radiation effects do not alter the performance of the component materials and
4 parts. Parts sourced from commercial vendors, if serving a nuclear safety function, must be dedicated
5 for their function using nuclear quality assurance (QA) programs according to U.S. Code of Federal
6 Regulations (CFR) parts 50 and 52 and/or the American Society of Mechanical Engineers (ASME) NQA-1
7 quality assurance standards. Additionally, DOE regulations also require compliance with 10CFR830,
8 Nuclear Safety Management, and DOE Order O-414.1D, Quality Assurance, among others.
9 Use of Additive Manufacturing
10 Neither the DOE nor NRC have issued any policy, standards, or guidance on the use and
11 qualification/acceptance of additively manufactured parts for general and/or nuclear safety
12 applications. However, as shown in Table 1, NRC has published both generic technical bases and
13 technology specific guidelines for areas of concern. In some cases, NRC has developed draft guidance
14 documents that still need to be finalized.
15
16 Table 1. Reports NRC published to provide more insight into the use of advanced manufacturing
17 technologies for reactor applications (J. Wise 3/16/2023 presentation from NRC Regulatory Information
18 Conference, (https://ric.nrc.gov/docs/abstracts/sessionabstract-32.html).
19 The DOD and NASA have issued standards and guidance for the use of safety components, systems, and
20 structures, while being fairly silent on their use in nuclear applications. The NRC is not a standards body
21 and its policy, thus far, is to defer to the primary standards bodies such as ASME, ASTM International,
22 the American Welding Society (AWS), and the International Organization for Standardization (ISO), to
23 provide the AM material, process, and qualification standards required to be used in nuclear
1 applications. The NRC is actively regulating and monitoring the use of AM parts within nuclear
2 applications. Recent test parts having been produced and installed in the nuclear fleet include
3 Westinghouse’s stainless steel thimble plugging device placed in service in Exelon’s Byron Unit 1 in May
4 2020. Another is a Framatome stainless steel fuel channel bracket produced and qualified in conjunction
5 with ORNL and placed in service in May 2021 in the TVA Browns Ferry Unit 2 nuclear power plant. To
6 date these are believed to be the only two AM parts installed into U.S. nuclear reactors in high-safety
7 roles. The NRC is also the licensing body, in conjunction with NASA, on nuclear battery and reactor
8 systems like the one powering the active Mars Rover and for future space exploration. These systems
9 have the potential to use AM parts, which necessitates additional policy and guidance on their use in
10 nuclear applications.
11 AM techniques, especially binder jetting technologies, are actively being used to research and produce a
12 new ceramic high-temperature fault-tolerant nuclear fuel called TRi-structural ISOtropic (TRISO) which is
13 actively being prototyped for production by several private nuclear companies. These fuels were
14 originally developed in the 1960s at Los Alamos National Laboratory (LANL), INL, ORNL and other labs.
15 Recent technological advances in AM and fuel process now allow full-scale production and
16 implementation.
17 The strengths and advantages of AM nuclear part production must be emphasized and directly
18 supported by nuclear regulators and research efforts. Generally, this includes rapid design iteration and
19 novel geometries and design optimizations not possible with traditional manufacturing methods. The
20 use of intelligent AM machines allows integration of advancements in embedded sensors, artificial
21 intelligence, and machine/system learning technologies that lend themselves to real-time understanding
22 of fabrication quality and performance. These technologies allow fabricators to know more about a
23 completed part than ever before in the history of modern manufacturing. They can and should be
24 brought to bear in complex and higher quality applications like the nuclear sector. Continued research
25 and testing of standards and qualification processes to embrace AM production, in-service inspection,
26 and critical characteristics of AM parts is required. Areas of interest include: material science, AM
27 techniques, finishing improvements, testing methods, and inspection, including non-destructive
28 evaluation (NDE), to address surface finish, complex geometries, dimensional tolerances, powder
29 residue and reuse, and closed cavities.
30 Relevant Programs and References
31 DOE NE AMMT 2022 Roadmap
32 The Advanced Materials and Manufacturing Technologies (AMMT) program will develop cross-cutting
33 technologies in support of current fleet and next-generation advanced nuclear reactor technologies and
34 maintain U.S. leadership in materials and manufacturing technologies for nuclear energy applications.
35 The overarching vision of the AMMT program is to accelerate the development, qualification,
36 demonstration, and deployment of advanced materials and manufacturing technologies to enable
37 reliable and economical nuclear energy. This roadmap identifies key research needs, challenges, and
1 opportunities; outlines strategic research priorities; and provides a detailed five-year plan to realize the
2 mission and vision of the AMMT program.
3 The major goals of the AMMT program are (1) to develop advanced materials and manufacturing
4 technologies that have cross-reactor impacts, (2) to establish a comprehensive framework for rapid
5 qualification of new materials made by advanced manufacturing, and (3) to accelerate
6 commercialization of new materials and manufacturing technologies through demonstration and
7 deployment.
8 Electric Power Research Institute (EPRI) Advanced Nuclear Technology (ANT) Program
9 The ANT program's mission is to reduce the risk and uncertainty of constructing and operating new
10 nuclear power plants. The program reviews existing technologies from inside and outside the nuclear
11 industry in order to evaluate and adapt those technologies best suited for use in nuclear power plants.
12 This is done by finding, defining, and extending useful and valuable existing technologies; performing
13 necessary R&D to determine the efficacy of those technologies in nuclear applications; and working
14 with codes and standards organizations to potentially enable effective use of the new technologies.
15 The program also performs R&D to help address new plant design challenges in the areas of
16 construction, operations and maintenance that can lead to optimized performance, during and after
17 construction. ANT also collaborates with various industry organizations to further the reach and
18 impact of the program"s research, including IAEA, WANO, and NEI.
19 EPRI funds private research into AM technologies for use in the nuclear energy sector.
20 EPRI presented the “Vision of Advanced Manufacturing Technology (AMT) Use in the Nuclear Industry,”
21 at the NRC Workshop on Advanced Manufacturing Technologies for Nuclear Applications, December 7-
22 10, 2020
23 Nuclear Energy Institute (NEI)
24 From the NEI Website:
25 NEI's mission is to promote the use and growth of nuclear energy through efficient operations and
26 effective policy.
27 NEI accomplishes this by providing a unified industry voice before Congress, the executive branch,
28 state and local legislatures, and federal regulators, as well as international organizations and
29 venues, on key policy issues.
30 From the Roadmap for Regulatory Acceptance of Advanced Manufacturing Methods in the Nuclear
31 Energy Industry, prepared by the NEI, May 13, 2019:
32 Advanced manufacturing methods (AMM) have the potential to transform the nuclear industry by
33 producing high quality components faster and cheaper, and enhancing the performance of current
1 operating plants and advanced reactors. AMM could also be used to quickly supply replacement
2 parts for obsolete components and to reduce warehouse inventories.
3 A number of companies are preparing to use AMM to fabricate components for current operating
4 plants and future advanced reactors. However, a lack of clarity on the regulatory pathways, and on
5 the ability to gain timely regulatory approval (if it is needed), for AMM fabricated nuclear
6 components are potential barriers to their use.
7 Gaps
8  Summary of Q&C standardization gaps identified:

9 o New Gap QC18: Production and Use of AM Parts in Nuclear Applications and Facilities.
10 o New Gap QC19: Nuclear AM Component In-service Performance.
11 o New Gap QC20: Nuclear Industry Use of Artificial Intelligence (AI) and Machine/System
12 Learning Technologies
13 o New Gap QC21: Nuclear Industry Use of Material and Production Data Combined with
14 Digital Analysis and Diagnostic Informed Qualification of AM Components
15 o New Gap QC22: Use and Qualification of AM Non-steel Advanced Materials in Support of
16 New or Advanced Nuclear Fuel and High-temperature Reactor Applications.
17 New Gap QC18: Production and Use of AM Parts in Nuclear Applications and Facilities. More research
18 and guidance are required to take advantage of AM production capabilities in the nuclear sector
19 including the ability to control grain structures, apply novel geometries, and rapidly produce parts for
20 repair, replacement, and/or production while meeting the requirements of applicable standards and
21 codes under radiological conditions.
23 R&D Expectations: DOE, NRC, and EPRI have solicited research and inputs on the use of AM parts in
24 nuclear applications. DOE Nuclear Energy (NE) has formed a program called the Advanced Materials and
25 Manufacturing Technology (AMMT) to continue work begun under the Transformational Challenge
26 Reactor (TCR) and other similar DOE laboratory programs that began the process of testing materials
27 and designs for nuclear applications, especially utilizing stainless steel. Early research supports the
28 potential use of AM metals and ceramics in high-heat radiological environments to support historical
29 and new nuclear reactor and facility needs. Additional research is required including the expansion of
30 materials to include high-heat ceramics, embedded sensors, in-situ monitoring, stainless and other
31 steels, including radiological effects on them, and the qualification of AM materials and related parts.
32 Recommendation: Additional guidance and research is required to support codes and standards
33 development, qualification, certification, implementation, disposition, and licensing of nuclear AM parts.
1 Organization(s): NRC, DOE (i.e., AMMT), NEI, EPRI, ASME, ASTM

4 Repair; ☒Data

6 ☒Energy; ☐Medical; ☐Spaceflight; ☐Other (specify) ______________________
7 Material Type: ☐All/Material Agnostic; ☒Metal; ☐Polymer; ☒Ceramic; ☐Composite
8 Process Category: ☐All/Process Agnostic; ☒Binder Jetting; ☒Directed Energy Deposition; ☒Material

11 ☒Personnel/Suppliers; ☒Other (specify)
12 Current Alternative: Individual and costly efforts to design and license AM parts through regulatory
13 processes. The lack of guidance and specifications is a barrier to rapid implementation.
15 ☒New
16
17 New Gap QC19: Nuclear AM Component In-service Performance. Performance of AM parts, when
18 installed in nuclear applications, is a function of location and access and is difficult to monitor due to a
19 lack of direct in-situ observation, time between outages, and radiological exposure concerns. Due to the
20 mechanism of layering powder in AM systems like Powder Bed Fusion and Directed Energy Deposition,
21 in-situ monitoring systems can be embedded within the parts during the production process that allows
22 real-time monitoring of part and reactor performance. The process of embedding sensors within AM
23 parts has been tested with some success at the national laboratories, but additional research is needed
24 to mature the process to production scale and initiate testing within the U.S. nuclear fleet.
26 R&D Expectations: Both the Department of Energy and the NRC have solicited research and inputs on
27 the use of in-situ monitoring and embedding sensors in AM parts in nuclear applications. DOE Nuclear
28 Energy (NE) has formed a program called the Advanced Materials and Manufacturing Technology
29 (AMMT) to continue work begun under the Transformational Challenge Reactor (TCR) and other similar
30 DOE laboratory programs that began the process of testing in-situ monitoring combined with ex-situ
1 examination techniques as inputs into AI and machine learning algorithms to rapidly detect potential
2 quality anomalies during the manufacturing process and monitor in-service performance.
3 Recommendation: Additional guidance and research is required to ensure the development,

4 qualification, certification, implementation, disposition, and licensing of nuclear AM parts utilizing
5 advanced monitoring and intelligent systems combined into a digital platform to help inform the quality
6 of AM parts.
8 Organization(s): NRC, DOE, NEI, EPRI, ASME, ASTM, AMMT
9 Lifecycle Area: ☐Design; ☐Precursor Materials; ☒Process Control; ☐Post-processing; ☒Finished

11 Repair; ☒Data
12 Sectors: ☐All/Sector Agnostic; ☒Aerospace; ☒Automotive; ☐Construction; ☒Defense; ☐Electronics;

13 ☒Energy; ☐Medical; ☒Spaceflight; ☐Other (specify) ______________________

18 ☒Personnel/Suppliers; ☒Other (specify) Combines computer controls, in-situ monitoring, and artificial
19 intelligence.
20 Current Alternative: Traditional in-service part monitoring requires costly techniques and processes or
21 removal from service for inspection.
23 ☒New
24
25 New Gap QC20: Nuclear Industry Use of Artificial Intelligence (AI) and Machine/System Learning
26 Technologies to Qualify AM Parts. There is a need for additional research, guidance, and standards on
27 the use of Artificial Intelligence and Machine/System Learning technologies and techniques to rapidly
28 inform AM part qualification and acceptance for high quality and safety applications in the nuclear
29 industry. AM part design and production allows for real-time monitoring of AM machine performance
30 and part quality that can inform production and quality personnel of potential issues with the machine,
31 build, and part performance. The use of modern intelligent computer and system learning applications
1 to rapidly identify potential AM quality and conformance issues has begun development and testing in
2 the national laboratories and private industry but needs additional support and research to mature for
3 application and acceptance by regulatory bodies, standards organizations, and quality organizations.
6 the use of AI and machine learning in AM nuclear applications. DOE Nuclear Energy (NE) has formed a
7 program called the Advanced Materials and Manufacturing Technology (AMMT) to continue work begun
8 under the Transformational Challenge Reactor (TCR) and other similar DOE laboratory programs that
9 began the process of testing in-situ monitoring combined with ex-situ examination techniques as inputs
10 into an AI and machine learning algorithms to rapidly detect potential quality anomalies during the
11 manufacturing process. Additional support and research are needed to mature application and
12 acceptance by regulatory bodies, standards organizations, and quality organizations.

16 of AM parts.

21 Repair; ☒Data


28 ☒Personnel/Suppliers; ☒Other (specify) Combines digital twin, computer controls, in-situ monitoring,
29 and artificial intelligence.
30 Current Alternative: Traditional part qualification requires costly testing and qualification processes.
2 ☒New
4 New Gap QC21: Nuclear Industry Use of Material and Production Data Combined with Digital Analysis
5 and Diagnostic Informed Qualification of AM Components. There is a need for additional research,
6 guidance, and standards on the use of analysis and diagnostic tools to analyze AM materials and build
7 data combined with AM digital twin, in-situ monitoring, Artificial Intelligence and Machine/System
8 Learning technologies, and techniques to rapidly inform AM part qualification and acceptance in the
9 nuclear industry. AM technologies and processes produce a significant amount of build and potential
10 performance data and information never before seen in the manufacturing industry. Mining and
11 analyzing this data from in-situ and ex-situ sources, material properties, testing, and quality inputs can
12 introduce a much more efficient system for identification of part issues, rapid qualification decisions,
13 and future references under a digital twin model. Additional work on digital platforms/systems that can
14 rapidly assimilate, mine, analyze and store AM part data is needed.
17 the use of AM parts in nuclear applications. DOE Nuclear Energy (NE) has formed a program called the
18 Advanced Materials and Manufacturing Technology (AMMT) to continue work begun under the
19 Transformational Challenge Reactor (TCR) and other similar DOE laboratory programs that began the
20 process of integrating material and test data combined with production data into AI and machine
21 learning algorithms in a digital platform to rapidly detect potential quality anomalies during the
22 manufacturing process.

26 of AM parts.

31 Repair; ☒Data


7 Current Alternative: Traditional part qualification requires costly testing and qualification processes.
9 ☒New
10
11 New Gap QC22: Use and Qualification of AM Non-steel Advanced Materials in Support of New or
12 Advanced Nuclear Fuel and High-temperature Reactor Applications. The new line of advanced reactors
13 for potential application in the U.S. nuclear energy fleets often operate at a much higher temperature
14 than the current typical U.S. nuclear reactor. The nuclear industry (and other industries) can benefit
15 from the use of additively manufactured non-steel materials such as ceramics for high-temperature
16 applications in reactor component and fuel production. High-temperature resistant ceramics such as
17 silicon carbide are being evaluated by the DOE and industry for use in nuclear fuels and core
18 components potentially replacing stainless or other steels and materials in certain high-heat
19 applications. These ceramics lend themselves to AM application and the benefits of rapid design and
20 production of complex geometries never before attempted.
23 the use of AM parts in nuclear applications. DOE Nuclear Energy (NE) has formed a program called the
24 Advanced Materials and Manufacturing Technology (AMMT) to continue work begun under the
25 Transformational Challenge Reactor (TCR) and other similar DOE laboratory programs that began the
26 process of development and testing of non-steel materials for use in AM nuclear applications. The ORNL
27 TCR program utilized previous DOE laboratory techniques and research originally developed in the 1960s
28 to improve the use of silicon carbide and similar ceramics in AM applications (typically, binder jetting) to
29 produce and test new forms of the high-heat tolerant fuels like the Tri-structural ISOtropic (TRISO)
30 encapsulated fuel and potential reactor core components. The TRISO fuel is the favorite of potential
31 new reactor designs due to its compact fuel density, high-heat tolerance, and improved radionuclide
32 retention capabilities combined into a much safer fuel form.
3 advanced non-steel materials for high-heat applications.

8 Repair; ☒Data


17 Current Alternative: Traditional part manufacturing and qualification requires costly testing and
18 qualification processes.
20 ☒New
21 2.3.3.6.2 Oil and Natural Gas Industry
22 Overview: As with other market segments, the big issue with additive manufacturing (AM) relates to
23 whether the finished products are suitable for service. The features of AM products, in addition to
24 geometry, that are critical for Oil & Gas products often include combinations of surface finish, residual
25 stress, microstructure, toughness, fatigue resistance, wear resistance (adhesive, erosive and abrasive),
26 mechanical and physical properties, corrosion resistance and environmental cracking resistance. The
27 service environments are very different between the products that are used to produce petroleum and
28 those used in the refining of petroleum. The exploration, drilling, completion of wells for production are
29 in the business segment known as “upstream” Oil & Gas. This contrasts with the transportation and
30 refining of products that are in the business segment known as “downstream” Oil & Gas. The interface
31 between the two segments is generally considered the exiting of petroleum products out of the series of
32 valves located at the wellhead.
1 The products used in the upstream segment have service temperatures that range from roughly -50°C to
2 +200°C and often need to be resistant to corrosion and environmental cracking in naturally occurring
3 acid gases (carbon dioxide and hydrogen sulfide) as well as salt (sodium chloride) and, occasionally,
4 elemental sulfur. The downstream products usually do not need to contend with many of the corrosion
5 related issues but may need to survive at temperatures up to 900°C and be resistant to both the
6 feedstock (oil) and by-products along the refining path.
7 Additive manufacturing is currently used for components in both the upstream and downstream Oil &
8 Gas Industry segments. The major end-users are all actively engaged in evaluating and using AM. The
9 major original equipment and service providers are involved in using and qualifying AM components The
10 widespread penetration into the Oil & Gas Industry was demonstrated by the size and width of the team
11 that developed API Standard 20S Additively Manufactured Metallic Components for Use in the
12 Petroleum and Natural Gas Industries. Some 215 members contributed from over 80 organizations
13 including end-users, original equipment manufacturers, AM machine manufacturers, and AM feedstock
14 manufacturers.
15 AM Processes and Materials being used: The laser PBF process is the most pervasive in terms of
16 number of applications but there is use of electron beam (EB) powder bed fusion (PBF), wire and
17 powder directed energy deposition (DED) and binder jetting (BJ) Though many different materials are
18 used, the most common alloys are 17-4PH and 316 stainless steels, 718 and 625 nickel alloys and
19 Ti6Al4V.
20 Published Standards and Codes
21 The published documents that are most referenced in Oil & Gas AM products include:
22  API STD 20S, Additively Manufactured Metallic Components for Use in the Petroleum and
23 Natural Gas Industries, First Edition (10/1/2021)
24  API STD 20T, Additively Manufactured Polymer-Based Components for Use in the Petroleum and
25 Natural Gas Industries First Edition (8/1/2022)
27 Manufacturing
28  ASME Boiler & Pressure Vessel Code Sections V, VIII and IX
29 In Development Standards and Codes
30 In the Oil & Gas Industry, API 20S and 20T are standards but not product standards. For these standards
31 to be required in Oil & Gas products, they need to be referenced in an API Product Standard. This was
32 recognized as a barrier to implementation of AM and the API Sub-Committee SC06 took this on as a task
33 to evaluate how API 6A, Specification for Wellhead Equipment, would need to change to address AM.
34 API 6A was selected because of known AM candidates as well as the API 6A standard being the key to
35 incorporating AM into multiple product standards. API 6A is the basis for material and quality
36 requirements in several additional API product standards. A working committee was formed in late 2021
1 to review and identify sections of API 6A that need to change to address AM and reference API 20S. The
2 working committee completed the task in June 2022 and it now goes to SC06 for
3 balloting/implementation. This is expected to be completed in 2023.
4 Recent activity related to but external to Oil & Gas includes ASME Code case 2020 and ISO/ASTM DIS
5 52904. The code case 3020 will be incorporated into AMSE B&PV Section IX, QW-600.
6 In July 2021, AMPP25 formed the TR21522 Task Group that is creating a technical report (TR) detailing
7 the current state of knowledge on corrosion testing for products that are manufactured using AM
8 processes. The TR21522 report is expected to be published in 2023 (discussed in greater detail in the
9 gap identified below). The membership of this TR is comprised of about 35 subject matter experts in AM
10 and corrosion. Though there is some emphasis on the Oil & Gas Industry, the membership encompasses
11 a broad spectrum from the various business segments. It was recognized from the onset that the effort
12 was more general in nature, applying to all industries.
13 New Gap QC23: Susceptibility of AM Products to Corrosion and Environmental Cracking Mechanisms.
14 There are no standards or reliable guidance for testing additively manufactured products for service
15 where a corrosion related mechanism is a major consideration. The resistance to corrosion and
16 environmental cracking mechanisms is often the limiting factor in applying AM to Oil and Gas products.
17 From a search of several industry sectors, this lack of guidance or standard is not isolated to Oil and Gas
18 products or to any particular industry.
20 R&D Expectations: The scope of AMPP TR21522 is to present the current state of knowledge and gap
21 analysis on corrosion testing of metallic materials for products that are manufactured using AM
22 processes. The report will include testing recommendations and identify existing applicable testing
23 standards that may need to be modified to address AM and where a suitable standard does not exist.
24 The scope of the report is not limited to any specific AM market sector and includes the state of the art
25 with respect to general corrosion, localized corrosion, high temperature oxidation, corrosion fatigue,
26 hydrogen or hydrogen sulfide associated cracking mechanisms, and stress corrosion cracking.
27 The TR21522 report is currently in the text drafting stage and the target date for ballot is June of 2023.
28 The work to date has revealed technology and knowledge gaps related to the subject. The current
29 assessment summary indicates that the existing AMPP and ASTM standards for corrosion and
30 environmental cracking are acceptable but will require some modifications to address the specifics
31 associated with additive manufacturing. The largest identified gap pertains to the selection and specifics
32 of the test sample used to measure resistance/acceptability.
25
AMPP, the Association for Materials Protection and Performance, was established in 2021 following a merger
between NACE International and SSPC: The Society for Protective Coatings.
1 The next step will be to assess and edit the identified corrosion test standards from the TR21522 report
2 to better address testing with respect to AM products. It is anticipated that a new standard will be
3 required to provide guidance on the selection of test specimens from AM builds/products.
4 Recommendation: Complete work on AMPP TR21522 and use the results to inform future work.
6 Organization(s): AMPP

9 Repair; ☐Data


16 ☐Personnel/Suppliers; ☒Other (specify) AM details, testing & prediction of product perform with
17 respect to corrosion related phenomena
18 Current Alternative: Each user lacking guidance on how to select specimens and how to test for
19 resistance to corrosion related degradation/failure mechanisms makes those decisions.
21 ☒New
22 2.3.3.7 Medical Industry26

23
24 2.3.3.7.1 Introduction
25
26 The medical industry adopted AM, to produce existing products as well as devices that may be patient-
26
Readers of this section are also encouraged to review other relevant parts of this roadmap that have application
to the medical industry. These would include, for example Design (2.1.2; 2.1.4.3), Finished Material Properties
(2.2.4.4), and Data (2.6.2; 2.6.11).
1 specific or integrated with lattice structures.27 Patient-specific devices (devices matched to a single
2 patient’s anatomy) are becoming more prevalent for surgical cutting guides and orthopaedic implants.
3 Consensus standards, used internationally and recognized by the FDA in the U.S., are important tools to
4 ensure the best information contributes to the evaluation of medical devices. Standards for traditional
5 manufacturing methods may not encompass all of the capabilities, parameters, and considerations for
6 AM. Additionally, international requirements and regulations may vary. This section will describe the
7 currently available standards, work in progress by the SDOs, and the gaps that need to be addressed
8 from a qualification and certification perspective.
9 In the U.S. market, the FDA has been proactive in terms of internal research, evaluation, and approval of
10 AM devices. FDA Guidance documents provide recommendations for device production and testing as
11 well as regulatory submission requirements. In addition, manufacturers can use recognized consensus
12 standards, established methods, or justified scientific rationale with validated test methods to show the
13 safety, effectiveness, or substantial equivalence of their medical devices. The FDA classifies medical
14 devices as Class I, II, or III depending on the risk associated with the device.28 This roadmap does not
15 directly reference FDA classification; rather, the roadmap categorizes devices as having short term or
16 long-term contact with an internal body system, and whether or not they are load bearing.
17 Standards gaps identified by the medical sector follow.
18 2.3.3.7.2 Data Output from Imaging Sources

19
20 Patient-specific data can be acquired by a variety of medical imaging modalities, including CT scan, MRI,
21 and ultrasound. The Digital Imaging and Communications in Medicine (DICOM) standard is overseen by
22 the Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers
23 Association (NEMA). The DICOM standard applies to communication and management of medical
24 imaging information and related data. The standard facilitates interoperability of medical imaging
25 equipment by specifying protocols for network communication, syntax and semantics of commands,
26 media storage, and file format structure. DICOM is the standard used by all manufacturers of X-ray, CT
27 scan, and MRI imaging equipment. However, the ability to capture radiological output data varies
28 depending on the manufacturer.
32 image data
27
While the discussion herein focuses on AM of medical devices, the FDA has approved at least one AM
pharmaceutical.
28
See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/
1  Radiological Society of North America (RSNA) 3D Printing Special Interest Group (SIG):
2 Guidelines for medical 3D printing and appropriateness for clinical scenarios (November 2018)
3 Gap QC6: Importing 3D Source Data to CAD Application for Creation of Design File. There is a need for
4 a standard to enable 3D source data to be imported to the CAD application for creation of a design file.
5 There is a concern that the data coming from the ultrasound equipment similar to the CT scan or MRI
6 data may not be providing adequately detailed images but this cannot be assessed until the
7 interoperability concerns are eliminated.
10 Recommendation: Develop a standard for importing 3D source data to the CAD application for creation
11 of a design file.
13 Organization: IEEE, ASTM F42/ISO TC 261 JG 70, ISO TC150/ASTM F04 JWG1, RSNA 3DP SIG

16 Repair; ☒Data


26 New
27 V3 Update: As noted in the text ISO/ASTM 52915 and 52916 have been published.
28 2.3.3.7.3 Data Acquisition for 3D Modeling: Imaging Protocols
29 The issue here is multifold:
1  Diagnostic CT and MRI image data is routinely acquired for the CAD file or modelling application
2 used to create the 3D file for use in the additive manufacturing process. However, the metadata
3 that describes the accuracy, precision, and quality of the source files may not meet the needs of
4 3D printed patient-matched medical devices.
5  Different imaging equipment has different installed protocols and many patient-matched
6 medical device manufacturers require specialized protocols.
7  There is a clinical balance between image quality and patient exposure.

10 image data
11 Gap QC7: Imaging Protocols. Problems associated with data acquisition for 3D modeling either
12 individually or in combination contribute to image inaccuracies that will result in inaccuracies of the 3D
13 model and eventually the final device produced. Imaging protocols typically balance patient exposure
14 and resolution. Therefore, alignment is needed between the imaging resolution requirements, the
15 printer resolution, and the final part accuracy and quality requirements.
18 Recommendation: Develop standard protocols for acquiring data for 3D modeling to ensure image
19 accuracy, precision, and quality of source files for validation of the AM design file.
21 Organization: IEEE, ASME, ASTM F42/ISO TC 261, RSNA (Radiological Society of North America),
22 American College of Radiology (ACR)

25 Repair; ☒Data


3 New
4 V3 Update: ISO/ASTM TR 52916, Additive manufacturing for medical-- Data -- Optimized medical image
5 data, was published. ASME V&V 40 Subcommittee on Verification and Validation in Computational
6 Modeling of Medical Devices is working to form a working group on this item.
7 2.3.3.7.4 Patient Imaging Files and Segmentation
8 There are currently no standards for patient imaging files within a clinical environment, including the
9 methods from standard-of-care medical images to print-ready files.
10 Process: Anatomical reconstruction is rarely done by the physicians themselves because it is: (a) time
11 consuming; (b) requires different technical skills than segmentation for visualization/quantification
12 purposes; and (c) uses a panoply of specialized software that is evolving frequently. Instead, a request to
13 print anatomy from a particular study is sent to expert staff at a “3D Printing Lab” (often an outgrowth
14 of a “3D Visualization Lab”). The physicians then review the 3D model and accept the print-ready file or
15 suggest revisions. Currently, no professional society certifies a technologist for 3D reconstruction or 3D
16 printing.
17 Consistency of data: Currently, most centers create print-ready files in common, and often open, file
18 formats (STL, VRML, OBJ, X3D, etc.). These file formats were created without the intended purpose of
19 medical integration. As such, these formats lack the structured schema and metadata needed for the
20 clinical environment such as patient name, medical record number, institution of origin, etc. Centers
21 currently rely on complex file naming conventions and deep folder hierarchies to tie the files to
22 particular patient studies. These conventions are not appropriate for a clinical environment where
23 information needs to be readily queried for medical needs (e.g., surgical planning).
25 ASME
26  ASME V&V 40-2018, Assessing Credibility of Computational Modeling through Verification and
27 Validation: Application to Medical Devices
28 FDA
29 Statements include:
30  On anatomical modeling: Di Prima M., Coburn J., Hwang D., Kelly J., Khairuzzaman A., Ricles L.
31 Additively manufactured medical products – the FDA perspective. 3D Printing in Medicine
32 [Internet]. 2016 Jun 18 [cited 2016 May 22]; 2(1). Paraphrased: Anatomical models may
33 sometimes be considered a hard copy of a medical image.
1  On other direct-contact 3D printing: Technical Considerations for Additive Manufactured
2 Devices: Final Guidance for Industry and Food and Drug Administration Staff (AM Technical
3 Guidance). Food and Drug Administration; 2017 December. Report No. UCM499809. See the
4 discussion under Identified Guidance Documents earlier in the Q&C section of this roadmap.
5 HL7
6 HL7 Standard for CDA Release 2: Imaging Integration; Basic Imaging Reports in CDA and DICOM, Release
7 1. This HL7 implementation guide describes how the HL7 Version 3 Clinical Document Architecture (CDA)
8 Release 2 is used to record information for a Diagnostic Imaging Report. A Diagnostic Imaging Report
9 contains a consulting specialist’s interpretation of image data. It is intended to convey the interpretation
10 to the referring (ordering) physician and become part of the patient’s medical record. Note: This
11 standard does not directly interact with 3D reconstructions currently, but will likely play a role following
12 DICOM integration.
13 ISO/ASTM
14 ISO/ASTM 52915:20, Specification for additive manufacturing file format (AMF) Version 1.2. The
15 standard for AMF file format includes the ability to incorporate meta data within the design file.
16 ISO/ASTM TR 52916:2022, Additive manufacturing for medical — Data — Optimized medical image data.
17 Per Section 12 of ISO/ASTM 52916, all appropriate metadata relating to the patient, institution of origin,
18 etc. as well as source scans, segmentation modifications, accuracy and precision of output files, etc. can
19 and should be added to the metadata list within the AMF file. This provides a reliable method to
20 programmatically store and transmit key metadata through the entire work flow. This provides a reliable
21 means of providing necessary information to validate and verify medical devices produced as compliant
22 to FDA QMS requirements. All that is required to implement this is for an appropriate medical standards
23 organization to provide the specific list of metadata schema and names to TC261 J64. This can be added
24 as part of a planned technical report providing guidance on use of the AMF file format in medical AM
25 applications, and to the next revision of ISO/ASTM 52915 as appropriate.
26 RSNA
27 RSNA has a special interest group (SIG) that has published best practices on segmentation.
29 Gap QC14: Segmentation. There are currently no standards for patient imaging files including the
30 methods from standard-of-care medical images to print-ready files. There is no group or entity that
31 oversees segmentation within a clinical setting.
1 Recommendation: There is a need to create an augmented file specification for the DICOM file format.
2 Incorporation of 3D files into the DICOM format will facilitate integration of 3D models into standard-of-
3 care medical image databases present at all institutions. 3D models should include enough information
4 to facilitate standardized methods for validation.
6 Organization: RSNA SIG, ISO TC 261/ASTM F42

9 Repair; ☒Data


19 New
21 2.3.3.7.5 Personnel Training for Image Data Set Processing
22 Image data sets are processed to create or replicate anatomy by “skilled personnel” to realize a 3D
23 model and/or the final medical device. The process requires a good knowledge of anatomy (for
24 identification of anatomical regions of interest [ROI]), graphic 3D design skills, and a fundamental
25 understanding of AM procedures.
26 Gap QC9: Personnel Training for Image Data Set Processing. Currently, there are only limited
27 qualification or certification programs (some are in process of formation) available for training personnel
28 who are handling imaging data and preparing for AM printing.
1 Recommendation: Develop certification programs for describing the requisite skills, qualification, and
2 certification of personnel responsible for handling imaging data and preparing for printing. The SME
3 organization currently has a program in development.
5 Organization: SME, RSNA, ASTM F42/ISO TC 261

8 Repair; ☒Data


18 ☐New
20 2.3.3.7.6 Phantoms
21 Phantoms refers to the creation of a physical object with known density and size properties for the
22 purpose of verifying the accuracy of a medical scanning device to check the accuracy of imaging data or
23 to be used for simulated in vitro imaging experiments.29 These phantoms can be used to check accuracy
24 as well as compare materials and processes. The process for creating accurate phantoms could also
25 apply to the creation of teaching aid models for surgeons.
26 No published or in development standards or specifications have been identified.
29
The term phantom is defined in ASTM E1441-00 (Std Guide CT) as a “test object containing features of known
size, spacing, and contrast, which can be scanned to determine spatial or density resolution.”
1 Gap QC8 Phantoms. Material and process guidelines are needed for phantoms to provide reliable
2 models for imaging experiments and to check the accuracy of the process. These would include which
3 materials and AM process to use, based on what is being imaged and the modality in use (e.g., X-ray vs.
4 ultrasound).
7 Recommendation: Develop guidelines for creating and using phantoms to include material and process
8 used, based on use. Similar to gap QC7, they may make use of standard image formats that capture
9 enough information to facilitate size, orientation and color normalization and/or validation in post-
10 processing of data.
12 Organization: Biomedical Engineering Society, NEMA/MITA, ISO, ASTM, RSNA

15 Repair; ☒Data


25 ☐New
27 2.3.3.7.7 Medical Materials and Materials Processing
28 All current AM materials for medical applications fall into the categories of potentially implantable or
29 non-implantable materials, with some of the current AM materials shown in Figure 2. In the figure, short
1 term (less than 30 days) and long term (greater than 30 days) refer to duration of patient-contacting
2 materials.
4 Figure 2: Examples of some AM materials for medical applications. Figure courtesy of Dr. Jayanthi
5 Parthasarathy and Lauralyn McDaniel
6 2.3.3.7.8 Qualification & Certification of the Finished Device
7 As per FDA guidance, even if the raw material is certified by the supplier, the device manufacturer is
8 responsible for qualification of the final device. Additionally, per the Code of Federal Regulations (21 CFR
9 820.70) and ISO 13485:2016, the device manufacturer is responsible for establishing and maintaining
10 procedures for the use and removal of manufacturing materials to ensure that the device’s quality is not
11 adversely affected. This is applicable to AM for a number of reasons: some raw materials are toxic in
12 their uncured state, and post-printing operations such as support structure removal, conventional
13 machining, polishing operations, sterilization, etc. expose the device to chemicals and manufacturing
14 materials that may be unsafe to the patient or that may adversely affect the device’s performance.
15 Published standards and regulations (Non-resorbable materials) include:
2 4 Vanadium with Powder Bed Fusion
4 4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
5  ASTM F3213-17, Standard for Additive Manufacturing – Finished Part Properties – Standard
6 Specification for Cobalt-28 Chromium-6 Molybdenum via Powder Bed Fusion
7  FDA 21 CFR 820.70, Production and process controls
8  ISO/ASTM52903-1-20 Additive manufacturing — Material extrusion-based additive
9 manufacturing of plastic materials — Part 1: Feedstock materials
10  ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory
11 purposes
12 No gap exists. ISO 13485:2016 and 21 CFR 820 adequately describe the need to ensure that the final
13 finished device – including raw materials, pigments, contact materials, etc. – meets the design
14 requirements and does not cause harm to the patient. Emerging material standards will be developed as
15 the need arises.
16 2.3.3.7.9 Resorbable Materials
17 Some polymers, such as polycaprolactone, polyglycolic acid, and polylactic acid, may resorb when
18 implanted in the body, allowing for replacement of the device by body tissues over time. Degradation
19 kinetics of the device depends on the chemistry of the material, and structure and design of the scaffold.
21  ASTM F1635-16, Standard Test Method for in vitro Degradation Testing of Hydrolytically
22 Degradable Polymer Resins and Fabricated Forms for Surgical Implants
23  ASTM F2902-16e1, Standard Guide for Assessment of Absorbable Polymeric Implants
24  ASTM F3160-16, Standard Guide for Metallurgical Characterization of Absorbable Metallic
25 Materials for Medical Implants
26  ASTM F3268-18a, Standard Guide for In-Vitro Degradation Testing of Absorbable Metals
27  ISO 10993-13:2010, Biological evaluation of medical devices -- Part 13: Identification and
28 quantification of degradation products from polymeric medical devices
29  ANSI/AAMI/ISO 10993-15:2000 (R2011), Biological evaluation of medical devices - Part 15:
30 Identification and quantification of degradation products from metals and alloys
31  ISO/TS 20721:2020, Implants for surgery – General Guidelines and requirements for assessment
32 of absorbable metallic implants
33  ISO/TR 37137:2014, Cardiovascular biological evaluation of medical devices -- Guidance for
34 absorbable implants
35  ISO/CD TR 37137-2, Biological evaluation of absorbable medical devices -- Guidance for
36 absorbable implants -- Part 2: Standard guide for absorbable metals
2
3  ASTM WK83979, New Guide for Corrosion Fatigue Evaluation of Absorbable Metals (formerly
4 WK61103)
5 No specific AM standards gap has been identified with respect to resorbable materials.
6 2.3.3.7.10 Biocompatibility Testing Standards Available for Resorbable and Non-

7 resorbable Materials
8 Existing standards include ANSI/AAMI/ISO 10993-1:2018, Biological evaluation of medical devices - Part
9 1: Evaluation and testing within a risk management process. This document supersedes Blue Book
10 Memorandum #G95-1 “Use of International Standard ISO-10993, Biological Evaluation of Medical
11 Devices Part 1: Evaluation and Testing,” dated May 1, 1995. The FDA also issued Technical
12 Considerations for Additive Manufactured Devices: Final Guidance for Industry and Food and Drug
13 Administration Staff (AM Technical Guidance) in December 2017. This includes FDA recommendations
14 for medical device submissions.
15 2.3.3.7.11 Material Control Data and Procedures
16 While no published standards or standards in development specific to AM have been identified for
17 medical applications, 21 CFR 820 provides the needed processes and data requirements. Specifically, §
18 820.65 – Traceability, § 820.140 - Handling , § 820.150 – Storage, and Subpart M--Records which
19 includes § 820.181 - Device master record, and § 820.186 - Quality system record details needs for
20 materials.
24  ISO/ASTM 52907:2019, Additive manufacturing — Feedstock materials — Methods to
25 characterize metal powders
26  SAE ARP7044 - Powder History Scoring Metric and Labeling Schema
29 Characterization Data for Additive Manufacturing
30  ASTM WK75184, Guide for Additive Manufacturing of Metals – Powder Bed Fusion – Guidelines
31 for Feedstock Re-use and Sampling Strategies
32  SAE AS7040, Requirements for powder distributors (Initiated Jun 28, 2021)
33  SAE AS7041, Distributor for AM build distributors Requirements (Initiated Jun 28, 2021)
1 Gap QC13: Material Control Data and Procedures. There is a need for well-established material control
2 data and procedures. Materials are primarily manufactured through proprietary methods and, while
3 recommended handling practices exist for each company and each product, standard procedures or
4 standardized considerations are not available.
7 Recommendation: A standard or specification describing a data set for material pedigree,

8 recommended testing, and handling procedures would simplify evaluation of material suitability.
10 Organization: Material providers, ASTM

13 Repair; ☒Data


22 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐Not Started; ☒Unknown; ☐Withdrawn; ☐Closed; ☐
23 New
24 V3 Update: None provided As noted in the text.
25 2.3.3.7.12 Qualification and Control of Suppliers
26 A medical device company should have procedures in place to control their suppliers. Additionally, when
27 they audit their suppliers, they should ensure that the supplier has the proper controls in place to
28 control their sub-suppliers. Qualification and control of suppliers will align with other industry guidance
29 and standards such as:
1  FDA Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
2  ANSI/AAMI/ISO 10993-1:2018, Biological evaluation of medical devices - Part 1:Evaluation and
3 testing within a risk management process
4  FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of
5 medical devices - Part 1: Evaluation and testing within a risk management process"
6 2.3.3.7.13 Quality, Verification, and Validation of Medical Product 3D Models
7 3D models are typically created for a region of interest (ROI). Image processing therefore entails
8 functions such as data segmentation (determining ROI), deleting (eliminating artifacts, noise, and non-
9 ROIs), smoothening, texturing (better visualization, surface finishing), and reducing post-processing
10 time. Models are transferred back and forth between image processing and graphic software to create
11 the best model.
12 Gap QC10: Verification of 3D Model. There are currently no standards for the final verification of a 3D
13 model after it is created from source imaging. The 3D model that goes into the AM fabrication system
14 must also be verified.
16 R&D Expectations: In terms of tolerances
17 Recommendation: Develop standards for verification of the 3D model.
19 Organization: ASTM F42/ISO TC 261 J64, AAMI, ASME, NIST, ACR, RSNA 3DP SIG

22 Repair; ☒Data


1 V3 Status of Progress: ☒Green; ☐Yellow; ☐Red; ☐Not Started; ☒Unknown; ☐Withdrawn; ☐Closed;
2 ☐New
4 2.3.3.7.14 Validation of Sterilization Processes
5 The issues of concern are: validation of the ability to clean, disinfect, and sterilize products intended for
6 subsequent processing and impact on final mechanical properties and geometric fidelity.
7 The U.S. FDA regulates medical products and requires data to support claims of sterility or claims that a
8 device can be sufficiently sterilized for use. A list of standards recognized by the FDA in this respect
9 (which includes standards and guidance related to equipment, facilities, and sterilization-related
10 microbiological testing) is available online.30 See also the FDA Guidance Submission and Review of
11 Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (issued
12 January 21, 2016).
13 Validation of sterilization processes: A number of published standards govern the validation of

14 sterilization processes used for medical devices, including ANSI/AAMI/ISO 11135:2014 (ethylene oxide
15 sterilization), the ANSI/AAMI/ISO 11137 series (radiation sterilization), the ANSI/AAMI/ISO 17665-
16 1:2006 (R2013) series (moist heat sterilization), and ANSI/AAMI/ISO 20857:2010 (R2015) (dry heat
17 sterilization). For animal tissue-based products sterilized via glutaraldehyde, ANSI/AAMI/ISO 14160:2011
18 (R2016) applies and AAMI TIR37:2013 provides guidance for the sterilization of human tissue-based
19 products using radiation. See also the FDA’s Guidance for Industry: Current Good Tissue Practice (CGTP)
20 and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based
21 Products (HCT/Ps). However, these standards were written for surface contact testing and did not
22 incorporate considerations for complex geometric structures that additive manufacturing can produce.
23 For products requiring unique sterilization processes, ANSI/AAMI/ISO 14937:2009 (R2013) governs. For
24 medical devices that cannot be sterilized to a Sterility Assurance Level (SAL) of 10-6, ANSI/AAMI
25 ST67:2019 provides a risk management framework for justifying alternative SALs. For medical devices
26 produced via aseptic processing, the ANSI/AAMI/ISO 13408 series provides guidance.
27 Validation of the ability to clean, disinfect, and sterilize products intended for subsequent processing:
28 ANSI/AAMI/ISO 17664:2017, Processing of health care products – Information to be provided by the
29 medical device manufacturer for the processing of medical devices (supersedes ST81) specifies what
30 information a medical device manufacturer must verify or validate for the cleaning, disinfection, and
31 sterilization of products intended to be sterilized by the product users (e.g., patients of healthcare
30
Go to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm and select “Sterility” in the
Specialty Task Group Area. The search results identify some 129 documents with further information available by
clicking on the title.
1 providers). AAMI TIR12:2020, Designing, testing and labeling medical devices intended for processing by
2 health care facilities: A guide for device manufacturers, provides guidance on designing, testing and
3 labeling devices intended to be sterilized by healthcare facilities or other device users. An international
4 technical specification, ISO/TS 19330:2017, Guidance on aspects of a risk-based approach to assuring
5 sterility of terminally sterilized, single-use health care product that is unable to withstand processing to
6 achieve maximally a sterility assurance level of 10-6, provides a framework for evaluating alternatives
7 for medical devices that cannot be adequately sterilized via standard protocols.
8 Reprocessing of reusable additively manufactured devices: Any device that is intended to be reused
9 should be reprocessed with a validated cycle per appropriate labelling as described in FDA Guidance on
10 “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” (issued March
11 17, 2015). The considerations for additively manufactured devices are not expected to be different than
12 devices made in other ways. Rather, it is of paramount importance to assess the material stability and
13 limitations of the chosen AM production process. AAMI TIR12, AAMI TIR30:2011 (R2016), A
14 compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable
15 medical devices, and ANSI/AAMI/ISO 17664:2017 (supersedes ST81) are also applicable.
16 Impact of sterilization on mechanical properties and geometric fidelity of medical products: The
17 standards for validation listed above require evaluation of the effect of the sterilization process on the
18 final product. Other testing (e.g., biocompatibility testing) is also required on medical devices in their
19 final sterilized state. AAMI TIR 17:2017(R2020), Compatibility of Materials Subject to Sterilization
20 provides information on materials compatibility with sterilization processes.
21 Gap QC15: Sterilization of AM Medical Products. AM medical products, such as anatomic models, can
22 be made in a healthcare setting. In some instances, these medical products may enter a sterile
23 environment and would therefore require sterilization. The effects of sterilization on the geometric
24 fidelity of the medical product should be assessed. While many standards and industry best practices
25 exist, procedures and protocols for determining appropriate materials, sterilization cycles, and
26 validation tests are available. There is a need for test methods to assess critical geometric features that
27 can be implemented in non-traditional manufacturing environments (e.g., healthcare facilities).
30 Recommendation: Develop test methods, guides, and best practices for AM medical products to help
31 identify critical parameters (e.g., geometric features) and apply existing sterilization standards in a
32 clinical setting.
34 Organization: AAMI, AOAC International, ASTM, ISO, Parenteral Drug Association (PDA), USP, RSNA 3DP
35 SIG.
3 Repair; ☐Data

6 Material Type: ☐All/Material Agnostic; ☐Metal; ☒Polymer; ☒Ceramic; ☐Composite

12 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐Not Started; ☒Unknown; ☐Withdrawn; ☐Closed; ☐
13 New
15 2.3.3.7.15 Sterilization of Tissue Engineered Products
16 Sterilization of tissue engineered products: There are some recognized standards and guidance in this
17 area (see above and see the work of ISO/TC 194/SC 1, Tissue product safety). Other standards exist (e.g.,
18 ANSI/AAMI/ISO 13022:2012, Medical products containing viable human cells - Application of risk
19 management and requirements for processing practices), that have not been recognized by the FDA.
20 Another international standard which was not recognized by the FDA or adopted by the U.S. is ISO
21 18362:2016, Manufacture of cell-based health care products - Control of microbial risks during
22 processing. The development of additional standards in this area may require more research and testing
23 and greater clarity and guidance from regulators.
24 Aseptic processing, or production under sterile conditions, of AM tissue-based products is another

25 method to ensure sterility of the final product. It is especially important when a construct contains cells
26 embedded in a printable, biocompatible substrate intended for implantation. FDA Guidance on Sterile
27 Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice provides an
28 overview of best practices. See also gap DE14.
29 Gap QC16: Sterilization of 3D Printed Tissue Engineered Products. 3D printed tissue engineered
30 products present a particularly challenging circumstance for sterility assurance. While using a validated
31 aseptic processing protocol for tissue engineered products can maintain sterility, it is not always
32 sufficient or practical. Risk management standards applied during the 3D printing process can help
1 decrease the risks of contamination but do not provide defined measures to ensure sterility or to assess
2 contamination.
4 R&D Expectations: A wide variety of aseptic processing and sterilization protocols exist for tissue
5 engineered products; however, no standards have been published to address validation and testing of
6 these protocols in 3D printed tissue engineered products.
7 Recommendation: Develop and validate standard methods of sterilizing and verifying the sterility of 3D
8 printed tissue engineered products, especially those that can be applied in healthcare settings.
10 Organization: R&D: OEMs, FDA, BioFabUSA. Standards: AAMI, ISO, ASTM, AATB.

13 Repair; ☐Data


23 ☐New
25 2.3.4 Conclusions
26
27 Text to be inserted.
28
29 Other Qualification & Certification Standards Activity Since Roadmap v2 - Relevance to
2  ISO/ASTM 52925:2022, Additive manufacturing processes — Laser sintering of polymer

3 parts/laser-based powder bed fusion of polymer parts — Qualification of materials (same as
4 WK72457 & WK73240)
5  ISO/ASTM 52936-1:2023, Additive manufacturing —Qualification principles – Laser-based
6 Powder bed fusion of polymers — Part 1: General principles, preparation of test specimens
7 (revision of ISO 27547-1:2010)
8 New In-Development Standards
9  ASTM WK71616, Additive manufacturing -- Qualification principles -- Part 2: Requirements for

10 industrial additive manufacturing sites (same as WK71269)
11  ASTM WK72659, Guide for Guideline for Material Process Validation for Additive Manufacturing
12 of Medical Devices
13  ASTM WK77614, Specification for Additive Manufacturing for construction Qualification
14 principles Structural and infrastructure elements (aka ISO/ASTM CD 52939)
15  ISO/ASTM FDIS 52920, Additive manufacturing — Qualification principles — Requirements for
16 industrial additive manufacturing sites (same as WK71269, WK71616 & WK72237)
17  ISO/ASTM DIS 52936-1, Additive manufacturing -- Qualification principles -- Laser-based powder
18 bed fusion of polymers -- Part 1: General principles, preparation of test specimens
19 2.4 Nondestructive Evaluation (NDE)

20 2.4.1 Introduction (metals)31
21 Nondestructive evaluation (NDE), also commonly known as nondestructive testing (NDT) or
22 nondestructive inspection (NDI), is one of the engineering disciplines used to verify the integrity of high
23 value components. Task-specific NDE methods have been developed over many years. The most
24 common methods recognized and controlled by industrial standards are: X-ray (including computed
25 tomography and digital radiography), dye penetrant, eddy current, magnetic particle, and ultrasonic
26 testing. Adaptations of all these methods should be under consideration for aerospace, medical,
27 automotive, energy, and other sectors that use AM components. As additive manufactured part’s
28 complexity and criticality grow, the reliance on computed tomography and other advanced NDE
29 methods has grown. Understanding and control of these techniques need to be addressed.
30 NDE methods to detect discontinuities and anomalies (defects, discontinuities, flaws, indications,
31 residual stresses and unmelted or partially fused powder etc.) are often cataloged by the character of
31
The scope of this NDE section is generally focused on additive manufacturing of metal components. Other
materials are discussed in section 2.4.6.
1 the anomalies it can detect and the location within the part for which the inspection method is best
2 suited. These anomaly locations are often referred to as: embedded (volumetric), subsurface (near and
3 below the surface), or surface. Embedded flaw detection methods include: acoustic emission, thermal
4 imaging, ultrasonic (i.e. pulse echo and through transmission ultrasound, process compensated
5 resonance testing (PCRT)] and X-ray radiography. Surface anomaly detecting methods include: acoustic
6 emission, dye penetrant, eddy current, magnetic particle, photogrammetry, ultrasonic (UT), and visual
7 testing (VT). Applicable NDE methods may be used during manufacturing (in-situ NDE), or after
8 fabrication or post-processing (ex-situ NDE).
9 NDE methods have differing outputs to display or record the testing results. For example, an X-ray
10 radiograph is viewed by an inspector who interprets what is recorded by the film or digital image. Film
11 based X-ray imaging is qualitative and dependent on the imaging direction and inspector skill, while
12 three-dimensional, digital X-ray imaging is quantitative and requires careful digital manipulation of the
13 data that involve converting 3D data into 2D-slices, which are then used to determine the size, shape
14 and distribution of the flaws. Ultrasonic pulse echo results are viewed in real time using an A-scan
15 presentation for real time inspection or an amplitude response C-scan map created during the scanning
16 of the part and subsequently interpreted by the inspector. The inspector sees a reflection as a
17 measurement of a returned signal (echo) “amplitude” either on the A-scan or C-scan map (normally
18 color-coded amplitude bar).
19 There are currently eight categories of processes used to manufacture AM metal parts. Each one has its
20 own level of complexity and presents challenges for NDE and the future standards that will provide the
21 direction or guidance of the inspection practices. The categories are:
22 
BJ, Binder Jet powder bed AM processing
23 
PBF-LB, Laser beam powder bed fusion
24 
PBF-EB, Electron beam powder bed fusion
25 
DED-LB, Laser beam directed energy deposition
26 
DED-EB, Electron beam directed energy deposition (EWAM)
27 
DED-GMA, DED-GTA, DED-PA, Gas metal arc, gas tungsten arc, and plasma arc directed energy
28 deposition processes32
29 AM non-metal and metal parts manufacturing categories are:
30  FDM / FFF / DIW – Fused deposition modeling, Fused filament fabrication, and Direct ink wiring
31 (material extrusion),
32  SLS – Selective laser sintering
33  SLA – Stereolithography (vat photopolymerization)
34  Material jetting
35  Sheet lamination
32
Including WAAM – Wire Arc AM (direct energy deposition)
1
2 A determination to separate or combine these different processes into one or more standards should
3 provide a coordinated answer to both NDE and equipment users. Many of the various drafts currently in
4 development appear either focused on the PBF processes or combine a mix of different processes.
5 The U.S. industrial and governmental NDE standardization needs or gaps have been evaluated and are
6 summarized in the discussion that follows. Figure 3 shows NDE gaps identified in this and previous
7 versions of this roadmap. The figure shows high, medium, and low priority gaps appear in bold, black,
8 and grey. Approved and draft standards or standards content appears in black and grey, respectively.
9 The status of Roadmap version 3 appears as green (completed), yellow (in progress), pink (not started),
10 grey (moved), or blue (new).
11
1
3 Figure 3: Additive Manufacturing NDE gap status as of 2023.
1 2.4.2 Common Defects Catalog Using a Common Language for AM Fabricated
2 Parts
3 2.4.2.1 Terminology
4 Historically, anomaly types, names, or classifications have been associated with the generating process,
5 e.g., castings may contain “shrinkage” and welds may contain “incomplete penetration.” There are also
6 overlapping anomaly types, for example, porosity. Additive manufacturing is another form of part
7 manufacturing with unique anomaly types and classifications associated with the process. The AM
8 industry and standards development organizations have groups formed addressing the need to establish
9 consensus anomaly descriptions.
10 As a new technology operating on principles many of which are foreign to conventional machining,
11 additive manufacturing needs industry agreement on definitions of specific terms to communicate flaws
12 and flaw types, ideas, and concepts, and to spur further innovation. In the absence of this common
13 agreement as to the precise meaning of words in their relative context, individuals and organizations
14 risk inevitable delays, misaligned objectives, and confusing outcomes. As an example, the words
15 “accuracy” and “precision” in common parlance are synonymous but, in metrology, the science of
16 measurement, they are not. Each describes a specific, unrelated attribute.
17 There are industry-based standards being developed both in the US and Europe. Published standards
18 addressing terminology but not the individual flaw types or classifications needed to accept or reject AM
19 parts by nondestructive testing include:
20  ASTM E1316-22a Standard Terminology for Nondestructive Examinations, developed by ASTM

21 E07.92 contains anomaly terminology useful for the NDE of AM parts.
22  ASTM E3166-20, Standard Guide for Nondestructive Examination of Metal Additively
25 for Laser Powder Bed Fusion
26  ISO/ASTM 52900:2021, Additive Manufacturing - General Principles - Fundamentals and
27 Vocabulary developed by ISO/TC 261 and ASTM F42 under their PSDO cooperation agreement
28  ISO/ASTM TR 52906:2022, Additive manufacturing — Non-destructive testing — Intentionally
29 seeding flaws in parts has defect terminology.
30  ISO/ASTM 52921:2013, Standard terminology for additive manufacturing - Coordinate systems
31 and test methodologies
33 Manufacturing.
1  ASTM WK75329, Standard Practice for the Nondestructive Testing (NDT), Inspection Levels and
2 Acceptance Criteria for Parts Manufactured with Laser Based Powder Fusion Aerospace
3 Components (under F42.07) will provide flaw terminology in support of the acceptance criteria
4  ISO/ASTM DTR 52905, Additive manufacturing of metals—Non-destructive testing and
5 evaluation—Defect detection in parts
6  ISO/ASTM AWI 52948 Additive manufacturing for metals — Non-destructive testing and
7 evaluation — Imperfections classification in PBF parts (see also ASTM WK83468)
8  ASME's Boiler & Pressure Vessel Code group will be looking at NDE of a pressure vessel. They are
9 also looking at working with ASTM.
10 Gap NDE1: Terminology for the Identification of AM Anomalies Interrogated by NDE Methods.
11 Industry driven standards related to defects have been developed. Many anomalies have been identified
12 but more effort is needed to adopt and reference harmonized anomaly terminology, with appropriate
13 names and descriptions, by the AM industry in standards. The logical repository for AM defect
14 terminology is ISO/ASTM 52900. Therefore, effort needs to be made to adopt consensus anomaly
15 terminology drawn from the existing published standards and from the in-development standards
16 mentioned above so that there is consistency across all voluntary consensus organizations. See also gap
17 FMP10.
18 R&D Needed: ☐Yes; ☐ No; ☒Maybe
19 R&D Expectations: There may be open ended questions arise as the AM industry considers adoption of
20 the NDE terminology because the effect of an anomaly (e.g., quasicrystalline microstructure) may need
21 to be studied.
22 Recommendation: ASME BPVC Section V NDE, ASTM F42, SAE AMS K, ISO TC 261 adopt standardized
23 defect terminology which identify and describe anomalies, and typical locations in a build.
25 Organization: ASTM E07, ASTM F42/ISO TC 261, SAE AMS K, ASME BPVC, AWS D20, NIST
26 Lifecycle Area: ☒ Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished

28 Repair; ☒Data

1 Q&C Category: ☒ Materials; ☐Processes/Procedures; ☐Machines/Equipment; ☒Parts/Devices;
3 Current Alternative: E3166 and ISO / ASTM DTR 52905 and 52906
5 ☐New
6 V3 Update: Standards development has matured, as noted in the text, and contain preliminary
7 definitions for AM anomalies, including pictures of technologically important anomalies, processing and
8 post-processing factors related to their generation and removal, and applicable NDE methods. The
9 ultimate goal is to ballot vetted definition for AM anomalies in ISO/ASTM 52900. Additionally, NDE
10 methods for welded metals are well established and should be reviewed for AM needs. The techniques,
11 minimum flaw sizes indicated and the naming conventions are used for welded metals to join metals
12 together and for weld metal buildups.
13 2.4.2.2 Equipment Standardization and Demonstration of NDE Capability
14 Additively manufactured metal parts are made by sintering or melting powder, wire, or other feedstock
15 primarily using two basic techniques referred to as powder bed fusion and directed energy deposition.
16 These two techniques employ different processing approaches but there are enough similarities to
17 create a list of flaws and defects, detectable by NDE examination methods, as tailored to the various
18 equipment approaches.
19 Currently, flaw types have been recognized by individual activities but lack formal review and
20 acceptance by the industry. Various U.S.-based committees have folded this subject into their purview
21 with little alignment. Calibration and phantoms are needed to standardize both industrial and medical
22 nondestructive equipment. Welding flaw types have been identified specifically in areas such as
23 electron-beam welding for fatigue critical applications. A possible approach is to categorize and catalog
24 allowable defects as shown in SAE AMS2680C-2019, Electron-Beam Welding for Fatigue Critical
25 Applications.
26 The ASTM Standard Guide E3166 (under the ASTM E07 committee on NDT) contains a table with defects
27 (Table 1) and their detectability using various NDE methods (Table 2). ISO/ASTM TR 52906:2022 Additive
28 manufacturing — Non-destructive testing — Intentionally seeding flaws in metallic parts was jointly
29 developed by ISO/ASTM to address “how to seed flaws” in AM processes for use in nondestructive
30 testing. Another work item, ISO/ASTM CD 52905 JG59, has categorised defects which are unique to AM
31 (after reviewing existing standards for casting and welding) and concentrates on creating artifacts with
32 such defects.
33 Additionally, in ISO TC261/ASTM F42 JG59 ‘NDT for AM Parts’ group we are working on the first of six
34 standards which will cover both PBF and DED. Each process will have three standards following the
35 welding standards format where the first one covers classification of imperfections; the second specifies
36 quality levels (criticality) and the last one specifies how to relate quality levels to NDT requirements. The
1 first one ISO TC 261 is working on is ISO/ASTM PWI 52948 Additive manufacturing of metals — Non-
2 destructive testing and evaluation —Imperfections classification in PBF parts.
3 Nondestructive testing uses physical standards – typically physical reference standards and
4 representative quality indicators (RQIs) – to ensure the equipment and measurement process are
5 functioning at a specified level. These are well-established for the inspection of mature product forms.
6 The complexities of emerging 3D printed parts require new approaches for fabrication of AM reference
7 standards and quality indicators to set and demonstrate equipment functionality. These new
8 approaches and standards must have industry acceptance as the basis for inspection techniques.
10  ASTM E1817-08(2022), Standard Practice for Controlling Quality of Radiological Examination by

11 Using Representative Quality Indicators (RQI)
15 Flaws in Metallic Parts (see also ISO/ASTM TR 52906:2022)
17  ASTM WK75584, Standard Test Method for Additive Manufacturing Non-destructive testing and
18 evaluation of fatigue cracks using tensioned computed tomography (F42.01)
19  ASTM WK76038, Standard Test Method for Additive Manufacturing of Metals -- Non-destructive
20 testing and evaluation -- Porosity Measurement with X-ray CT (F42.01)
21  ASTM WK83515, Standard Specification for Additive manufacturing - Non-destructive testing
22 and evaluation - Defect classification in metallic PBF parts (F42.01)
23  ASTM WK83468, Standard Classification for Additive manufacturing for metals -- Non-
24 destructive testing and evaluation -- Imperfections classification in PBF parts (F42.01)
25  ASTM WK84977, New Practice for controlling Computed Tomographic (CT) dimensional
26 measurement performance by using Representative Quality Indicators (RQIs) (E07.01)
28 evaluation—Defect detection in parts
29  ISO/ASTM AWI 52948, Additive manufacturing for metals — Non-destructive testing and
30 evaluation — Imperfections classification in PBF parts
31 Gap NDE2: Standard for the Design and Manufacture of Physical Reference Standards, Image Quality
32 Indicators, and Representative Quality Indicators to Demonstrate NDE Capability. One published
33 standard exists (ISO/ASTM 52906) for the design or manufacture of specimens that contain intentionally
34 seeded flaws that can be used to calibrate NDE equipment or demonstrate detection of naturally
35 occurring and intentionally introduced anomalies (lack of fusion, porosity, etc.), or intentionally added
36 features (watermarks, embedded geometrical features, etc.). ISO/ASTM JG59 (previously JG60) has
37 published 52906 which includes ways to design and manufacture artefacts or parts with such defects.
1 ISO/ASTM CD 52905 JG59 is partially addressing this with seeded “imperfections” (or flaws) and
2 demonstration of NDT detectability. This standard should identify the naturally occurring anomalies and
3 intentional features. This standard should also include recommendations regarding the use of existing
4 subtractive machined calibration standards or AM representative artifacts or phantoms. When Image
5 Quality Indicators (IQI) do not work which are representative of the material and process,
6 Representative Quality Indicators (RQI) may be used that are representative of the production part and
7 expected anomaly state. The use of IQIs and RQIs is common in X-ray-based NDE methods such as RT
8 [including digital radiography (DR) and computed radiography (CR)], and in CT. The use of RQIs should be
9 considered for incorporation into the standard(s).
10 R&D Needed: ☒Yes; No; ☐Maybe
11 R&D Expectations: (1) Consistently and successfully printing phantoms and measuring them inside the
12 RQI bodies. (2) R&D to define all anomalies that affect the performance of a product and calibration of
13 NDE methods for quantitative analysis of durability of the AM products. (3) Methods to develop
14 phantoms for X-ray CT probability of detection (POD) analysis using AM, traditional manufacturing, and
15 advanced micro/nano-fabrication techniques. The approach of generating artificial flaws may be
16 different for different NDT methods as well.
17 Recommendation: Complete work on applicable ASTM F42/ISO TC 261 standards (JG59) and ISO/ASTM
18 DTR 52905.
20 Organization: ASTM F42/ISO TC 261

23 Repair; ☐Data


31 Current Alternative: Internal practices
2 ☐New
3 V3 Update: As noted in the text. See also sections 2.1.7 Design for Anti-counterfeiting (gap DE29);
4 2.2.2.23 (process control); and 2.4.2 gap NDE7.
5 2.4.3 Test Methods or Best Practice Guides for NDE of AM Parts

6 Additive manufacturing technologies for the development, prototyping, and production of 3D printed
7 objects are maturing rapidly. There are several different process categories of AM technology being
8 developed. Due to the rapid advancement of additive manufacturing, NDE practitioners new to the
9 inspection of additively manufactured objects are not aware of the differences in the process categories
10 and the flaws they can produce. NDE practitioners need to be made aware of the types of flaws each
11 process method can produce and the appropriate NDE methods for detecting those flaws.
12 Although there are some commonalities in the types of defects in AM parts compared to the defects in
13 parts made by conventional processes such as casting, forging, and welding, AM parts can have
14 additional unique defects such as trapped powder and layer defects. In addition, AM typically provides
15 an increased level of geometric complexity, which increases the risk deeply embedded volumetric
16 defects may be missed during inspection. Some are being addressed in ISO/ASTM CD 52905 JG59.
17 Published NDE standards include those under the jurisdiction of ASTM committee E07 and SAE AMS
18 committee K. These NDE process standards contain the details necessary to control the application of
19 each NDE method in general or to a specific application (e.g., welding, castings, forgings). Each NDE
20 method must have acceptance levels for accurate and repeatable results, which are typically referred to
21 as classes. The standard classes can be used in engineering analysis and provide quality criteria for
22 acceptability. By way of example, ultrasonic inspections for wrought products use flat bottom holes
23 defined by ASTM E127-20 and implemented as acceptance classes in SAE AMSSTD2154E and ASTM
24 E2375-22. Similarly, X-ray inspection of titanium castings uses reference radiographs to measure
25 severity as defined in ASTM E1320-20. Acceptance standards may be imbedded in the process standard
26 or in a stand-alone standard such as MIL-STD-1907 NOT 6 for the penetrant inspection of castings and
27 weldments. Many of these existing standards will be directly applicable to objects produced by AM
28 without modification. Some modification or new standards may be needed for the complex objects
29 produced by AM that were not possible using conventional manufacturing techniques.
30 ASTM E3166-20e1 Standard Guide for Nondestructive Examination of Metal Additively Manufactured
31 Aerospace Parts After Build and ISO/ASTM DTR 52905 Additive manufacturing of metals — Non-
32 destructive testing and evaluation — Defect detection in parts provide the NDE industry starting points
33 for designing inspection processes for additively manufactured objects. The knowledge generated with
34 the creation of these documents will establish a baseline for determining when existing NDE standards
35 can be used and where new ones specific to additive manufacturing must be developed. Current
36 inspection results indicate that object which are similar to those manufactured by traditional methods
37 can be inspected using existing standards. To enhance detection of relevant defects, post-processing of
1 the additively manufactured objects may be required to allow the use of currently released non-process
2 specific NDE standards.
3 Several applications have been identified where additive specific NDE standards are needed. One
4 example is the CT of complex parts which ASTM work item WK71550 intends to address. Additional ones
5 can be found in the In-development standards section below.

8 Manufactured Aerospace Parts After Build (revision underway, see ASTM WK78773)
10 Flaws in Metallic Parts
11

14 evaluation—Defect detection in parts (anticipated approval in spring 2023)
15  ASTM WK69731, Guide for Additive Manufacturing -- Non-Destructive Testing (NDT) for Use in
16 Directed Energy Deposition (DED) Additive Manufacturing Processes (F42.01)
17  ASTM WK71550, New Practice for Computed Tomographic Examination of Additive
18 Manufactured Parts (E07.01)
19  ASTM WK75584, New Test Method for Additive Manufacturing Non-destructive testing and
20 evaluation of fatigue cracks using tensioned computed tomography (F42.01)
21  ASTM WK76038, New Test Method for Additive Manufacturing of Metals -- Non-destructive
22 testing and evaluation -- Porosity Measurement with X-ray CT (F42.01)
23  ASTM WK78465, New Specification for Additive Manufacturing for Medical- Non-destructive
24 Testing and Evaluation-Test Method for Evaluation of Porous Structures in Medical Implants via
25 Computed Tomography Scanning (F42.07)
26  ASTM WK78911, Standard Guide for Additive Manufacturing of Metal -- Finished Part Properties
27 -- Methods for Density Measurement (F42.01)
28  ASTM WK81106, New Test Method for Standard Practice for Impulse Excitation Resonance
29 Frequency Testing (E07.06)
30  ASME is looking at NDE vis-a-vis its boiler and pressure vessel code (Section V BPVC).
31
32 Gap NDE3: Standard Guide for the Application of NDE to Objects Produced by AM Processes. There is a
33 need for an industry-driven standard led by nondestructive testing experts and supported by the
34 additive manufacturing community to assess current inspection practices and introduce nondestructive
35 testing and inspection requirements.
1 R&D Expectations: Round robin testing is underway under ASTM WK78773 (revision of E3166-20e1) to
2 bring in new resonant ultrasonic spectroscopy (RUS) method for whole body characterization of parts.
3 that complements the existing process compensated resonance testing (PCRT) method. This method,
4 which is being developed by E07.06 (see ASTM WK81106) involves impulse excitation resonance
5 frequency testing. Also, reference radiographs used for radiographic testing of castings and welds are
6 needed for additive manufacturing (see gap NDE10). A future need will be to spin off test methods from
7 E3166 and ISO/ASTM 52905 guides, which contain precision and bias statements that can be used in
8 accept/reject and in procurement of AM parts.
9 Recommendation: Complete work on in development standards listed above.
11 Organization: ASTM E07, ASTM F42/ISO TC 261, ASME, NIST

14 Repair; ☐Data


21 ☐Personnel/Suppliers; ☒ Other (specify) Test coupons and phantoms
22 Current Alternative: Current draft of ASTM E3166
24 New
25 V3 Update: ASTM WK78773 and ISO/TC 261/JG 59 are in development. ASME is also looking at NDE vis-
26 a-vis its boiler and pressure vessel code. The International Committee for Non-Destructive Testing
27 (ICNDT) has formed a specialist international group on NDT reliability to address the deficiencies. There
28 are working groups on standardization of reliability evaluations, human and organizational factors, and
29 reliability for NDE 4.0. Additive manufacturing is one of the interests in this group.
30 2.4.3.1 NDT Reliability Assessment
31 NDT reliability assessment is a critical aspect of NDT qualification. To demonstrate NDT reliability, the
32 concept of probability of detection (POD) has been used to demonstrate NDT flaw detection capability
1 and uncertainty associated with the process. The concept was adopted for many industries (e.g.,
2 aerospace, military, and energy/nuclear) using fracture critical components. POD relies on a monotonic
3 relationship between the flaw size and the probability that the flaw will be detected. Based on the POD
4 curve, the largest true flaw size that can be missed during the inspection (i.e., a90/95, true flaw size with
5 90 % POD with 95 % confidence) can be estimated. This value allows one to estimate in-service
6 inspection interval by assuming that a flaw with this size (a90/95) exists in the part. The POD curves for
7 pre-service and in-service inspections can be direct inputs for probabilistic fracture mechanics
8 simulation, which estimates the risk of the component. For AM components used for critical
9 applications, POD of NDT inspection is expected to be required by regulatory agencies.
10 POD curves are generally estimated based on empirical inspection trials of representative phantoms
11 with flaws. The process can be both costly and time-consuming, and there exist challenges associated
12 with developing phantoms for complex AM designs. Customized parts or design change may require
13 quick modification of phantoms. Model-assisted POD (MAPOD) approach potentially reduces the NDT
14 validation costs by fully or partially replacing practical NDT trials with simulation results made from NDT
15 models. The NDT simulations require validation against physical measurements to ensure they are
16 realistic. Realistic simulation reduces burdens of phantom fabrication and making measurements. More
17 advanced statistical models can also reduce experimental needs or help merge similar experimental and
18 simulation results. In addition to traditional flaw size parameter, multiple parameters of flaw
19 characteristics or NDT acquisition settings need to be considered with POD estimation (e.g., multi-
20 parametric POD). Simulation models can help optimize NDT inspection parameters to reduce
21 uncertainty. Simulations for POD should also factor in the normal measurement-to-measurement
22 variation caused by equipment.
23 The POD curves estimated from laboratory measurements and simulation only accounts for intrinsic
24 measurement capability. In many inspection scenarios, human inspectors are still making the NDT
25 inspections and decisions. The human inspector can be affected by various field conditions such as
26 organizational pressures (e.g., deadlines, revenue goals, etc.) and the environment (e.g., temperatures,
27 concern with radiation exposure, etc.). Various human and organizational factors need to be considered
28 for more realistic POD curve estimation.
29 Many emerging NDT techniques and their advancements allow automated/assisted flaw detection using
30 computer algorithms, which provides various characteristics of the anomalies in addition to simple
31 detection of the existence of the anomalies. These algorithms may involve data-driven AI and/or
32 machine learning (ML) algorithms. There is a growing need to assess accuracy, trustworthiness, and
33 reliability of these algorithms used for NDT applications.
35  API RP 581, Risk-Based Inspection Methodology (Oct 2020)

36  ASTM E2862-18, Standard Practice for Probability of Detection Analysis for Hit/Miss Data
37  ASTM E3023-21, Standard Practice for Probability of Detection Analysis for â versus a Data
1  ASTM E3327/E3327M-21, Standard Guide for the Qualification and Control of the Assisted
2 Defect Recognition of Digital Radiographic Test Data (E07.01)
3  DIN EN 16991:2018, Risk-Based Inspection Framework
4  NASA-STD-5009, Nondestructive Evaluation Requirements for Fracture Critical Metallic
5 Components
6  MIL-HDBK-1823A, Nondestructive Evaluation System Reliability Assessment (2009-04-07)
7
9  International Committee for Non-Destructive Testing (ICNDT) SIG: NDT Reliability

10 (https://www.icndt.org/ICNDT-Activities/NDTReliability)
11  British Institute of Non-Destructive Testing (BINDT) technique validation working group
12
13 New Gap NDE11: Reliability of NDT. Current standards only cover binary and signal response (𝑎̂ 𝑣𝑠 𝑎)
14 POD analysis methods based on logistic or linear regression. There are needs for standards and guidance
15 documents dealing with more advanced statistical models, physics-based simulation models, and
16 applications incorporating other factors affecting NDT inspection. Complex AM designs can pose
17 challenges to developing physical reference standards, IQIs and RQIs with representative flaws, and the
18 uses of NDT simulation tools and advanced statistical models are expected for model-assisted or model-
19 based qualification. Guidance on incorporation or assessment of human factors and the evaluation of
20 automated detection/measurement algorithms are also needed.
22 R&D Expectations: R&D is needed to improve POD analysis using advanced statistical model, using
23 realistic simulation models, incorporating human factors, and incorporating automated/assisted flaw
24 detection algorithms.
25 Recommendation: Develop standards or guidance documents on using advanced statistical model for
26 POD analysis. Develop standards or best practice documents on implementing model-assisted or model-
27 based approach POD analysis or NDT qualification. Topics such as physics-based model validation,
28 calibration of the simulation model, statistical models to combine experimental and simulation results
29 are expected to be discussed for various NDT techniques. Develop or improve physics-based simulation
30 tools for emerging NDT techniques and develop workflows/tools to computationally seed desired type
31 of flaws in realistic part geometry. Standards or guidance documents on carrying out POD analysis for
32 different parameters of the flaws or NDT inspection process may be needed. Extension of NDT from
33 binary flaw detection to flaw characteristic measurements (e.g., flaw sizing accuracy) may be discussed.
34 Develop standards or guidance documents on estimating and incorporating human factors or
35 organizational factors into POD analysis. Standards or guidance documents on assessing accuracy of
36 automated/assisted detection algorithms and incorporation to POD analysis are needed.
1 Organization(s): API, ASTM, DIN

4 Repair; ☐Data

8 Process Category: ☐All/Process Agnostic; ☐Binder Jetting; ☒Directed Energy Deposition; ☐Material
10 Q&C Category: ☐Materials; ☒Processes/Procedures; ☐ Machines/Equipment; ☒Parts/Devices;

12 Current Alternative: Internal procedures, NASA-STD-5009 imposes POD requirements; or USAF is using
13 MIL-HDBK-1823A
15 New
16 2.4.3.2 3D Image Quality Indicators (IQI)
17 In 2D radiography there exists a prescribed method to evaluate either the radiographic technique, the
18 radiographic system, or both. These are referred to as Image Quality Indicators (IQIs) and wire line pairs.
19 These tools are used as a visual aid for the technician, and other interested parties, to ensure that a pre-
20 described minimum radiographic dataset quality has been achieved and to provide evidence that the
21 radiographic system is functioning as desired. Wire line pairs are used to evaluate the minimum spatial
22 resolution of the system and the IQI is used to ensure that a minimum optical density change is
23 observable.
24 The above-described issue is not to be confused with, nor replace, part specific Representative Quality
25 Indicators (RQIs) which are designed to provide evidence that the prescribed imperfection(s) (minimum
26 flaw size, distribution, material conditions, etc.) are captured within the specific radiographic dataset for
27 each individual part geometry.
28 To this point there does not exist a public standard to verify the image quality, the system performance,
29 and objective quality of CT data acquisition systems. Currently, CT systems are qualified by RQIs with
30 pre-identified flaws which are used to provide evidence that the data is comparable and repeatable. This
31 lack of a global 3D Image Quality Indicator (IQI) creates a subjective approach to comparing CT system
1 capability and equivalence. This need is independent of the need for a reference quality indicator (RQI)
2 for specific part inspection.
4  ASME B89.4.23: 2020, X-Ray Computed Tomography (CT) Performance Evaluation provides
5 guidance for performance evaluation for users of the machine to assess.
6  ASTM E1695–20e1 Standard Test Method for Measurement of Computed Tomography (CT)
7 System Performance)
8  ASTM E1441-19: Standard Guide for Computed Tomography (CT)
9
11  ASTM WK84836 New Practice for Standard Practice for Visual Determination of Computed
12 Tomographic (CT) Image Quality (in development in E07.01)
13
14 New Gap NDE12: 3D Image Quality Indicator for determining the sensitivity of a CT system. A 3D IQI
15 will provide objective evidence for the sensitivity of a CT system independent of the final part geometry
16 scanned.
18 R&D Expectations: An 3D IQI that produces CT image data sets which accurately represent system
19 sensitivity.
20 Recommendation: Complete work on ASTM WK84836 to publish a 3D Image Quality Indicator for CT
21 systems standard
23 Organization(s): ASME; ASTM E07.01.02 Radiology (X and Gamma) Method, Non-Film Methods

26 Repair; ☐Data

1 Q&C Category: ☒Materials; ☐Processes/Procedures; ☒Machines/Equipment; ☒Parts/Devices;
3 Current Alternative: Proprietary methods for comparing CT system sensitivity.
5 ☒New
6 2.4.3.3 Reference Radiographic Images
7 Radiographic testing of castings and welds rely on reference radiographic images and associated
8 acceptance standards. Work has not been done by SDOs to develop reference radiographic images for
9 the types of anomalies produced in additive manufacturing and the 3D radiographic test (primarily CT)
10 used to inspect for them.
12  No published standards were identified.

13
15  WK84977 Standard Practice for Standard practice for controlling Computed Tomographic (CT)
16 dimensional measurement performance by using Representative Quality Indicators (RQIs)
17
18 New Gap NDE13: Reference Radiographic Images and Standards for Additive Manufacturing
19 Anomalies. To standardize the radiographic inspection of additive manufactured components, reference
20 radiographic data (2D and 3D) of common anomalies in AM need to be developed.
22 R&D Expectations: Reference radiographic images (2D and 3D) for additive manufacturing anomalies.
23 Recommendation: Develop reference radiographic images (2D and 3D) and acceptance standards for
24 additive manufacturing anomalies.
26 Organization(s): ASTM E07.02 Reference Radiological Images

29 Repair; ☐Data

8 Current Alternative: Proprietary test methods and acceptance criteria
10 ☒New
11 2.4.4 Dimensional Metrology of Internal Features

12 The additive manufacturing process presents unique challenges in dimensional and surface roughness
13 measurement. Additive manufacturing processes can produce internal features that are difficult to
14 impossible to measure using traditional methods. Internal structures, tolerances and their limits, and
15 surface roughness of complex 3D structures cannot be measured with traditional metrological methods.
16 Destructive measurement methods can be used to measure these features but result in lower process
17 yields from the cut-up process. Radiographic, ultrasonic, or electromagnetic techniques may produce
18 results that differ from those generated by destructive evaluation creating the need to establish
19 correlations. Therefore, accurate dimensional measurement is a challenge for internal features created
20 by the AM process.
21 Among measurement technologies, X-ray computed tomography (CT) can measure internal features
22 after fabrication and structured light can measure external features either during or after fabrication. CT
23 technology provides important measurements such as wall thickness and radii of complex internal
24 hollow structures that are otherwise impossible to measure.
25 Additive manufacturing processes may produce surfaces with high surface roughness, variable surface
26 roughness or both. Surface roughness is difficult to assess on internal features or over large surfaces.
27 Surface roughness may meet the print specifications but there can be abnormalities (uneven surface,
28 etc.) from the build that may impact part performance. All these factors must be kept in mind when
29 applying measurement techniques to AM parts.
31 Published CT or related standards include:
32  ASTM E1441-19, Standard Guide for Computed Tomography (CT)
1  ASTM E1570-19, Standard Practice for Fan Beam Computed Tomographic (CT) Examination
2  ASTM E1695–20e1 Standard Test Method for Measurement of Computed Tomography (CT)
3 System Performance).
6  ASTM E3375-23, Standard Practice for Cone Beam Computed Tomographic (CT) Examination
7  ASME B89.4.23-202,0 X-Ray Computed Tomography (CT) Performance Evaluation
8  ISO 15708-1:2017, Non-destructive testing – Radiation methods for computed tomography –
9 Part 1: Terminology
11 Part 2: Principles, Equipment and Samples
13 Part 3: Operation and Interpretation
15 Part 4: Qualification
16  VDI/VDE 2630 Blatt 1.1, Computed tomography in dimensional measurement: Fundamentals
17 and definitions
18  VDI/VDE 2630 Blatt 1.2, Computed tomography in dimensional measurement: Influencing
19 variables on measurement results and recommendations for computed tomography
20 dimensional measurements
21  VDI/VDE 2630 Blatt 1.3, Computed tomography in dimensional measurement: Guideline for the
22 application of DIN EN ISO 10360 for coordinate measuring machines with CT sensors
23
24 Standards on techniques to evaluate measurement uncertainty using CT:
25  ISO 15530-3:2011, Geometrical product specifications (GPS) - Coordinate measuring machines

26 (CMM): Technique for determining the uncertainty of measurement - Part 3: Use of calibrated
27 workpieces or measurement standards is often used as a technique to look at CT, but is not CT
28 specific.
29  VDI/VDE 2630 Blatt 2.1, Computed tomography in dimensional measurement: Determination of
30 the uncertainty of measurement and the test process suitability of coordinate measurement
31 systems with CT sensors (an adaptation of ISO 15530-3)
32
34  ASTM WK61161, New Practice for Volumetric Computed Tomographic (CT) Examination (E07.01)
35  ASTM WK71550, New Practice for Practice for Computed Tomographic Examination of Additive
36 Manufactured Parts (E07.01)
37  ASTM WK78465, Specification for Additive Manufacturing for Medical- Non-destructive Testing
38 and Evaluation-Test Method for Evaluation of Porous Structures in Medical Implants via
39 Computed Tomography Scanning (F42.07)
1  ASTM WK84836, Standard Practice for Standard Practice for Visual Determination of Computed
2 Tomographic (CT) Image Quality (E07.01)
3  ASTM WK84977, New Practice for controlling Computed Tomographic (CT) dimensional
4 measurement performance by using Representative Quality Indicators (RQIs) (E07.01)
5  ISO 10360-11, Geometrical product specifications (GPS) - Acceptance and reverification tests for
6 coordinate measuring systems (CMS) - Part 11: CMSs using the principle of X-Ray computed
7 tomography (CT) (deleted)
8  ISO TR 11335, Structural Resolution Tests for X-Ray Computed Tomography used in Dimensional
9 Measurement Applications
10
11 It should be noted that, while the above CT standards address internal metrology indirectly (E1570 and
12 E1695) providing a basis for dimensional metrology of internal features in AM parts, none are written
13 specifically for AM parts.
14 Gap NDE4: Dimensional Metrology of Internal Features. The utility of existing and draft CT standards is
15 needed for the dimensional measurement of AM internal features and surface roughness.
17 R&D Expectations: Characterization of machine performance and task specific measurement

18 uncertainty on AM parts.
19 Recommendation: ASTM E07 should address the applicability of current and draft CT standards (E1570,
20 E1695, and WK61161) for measurement of internal features and surface roughness in additively
21 manufactured parts, especially parts with complex geometry, internal features, and/or embedded
22 features. Current CT metrology state-of-the-art needs to be tailored to evolving AM part inspection
23 requirements. See also gap DE26, Measurement of AM Features/Verifying the designs of features such
24 as lattices, etc. Standard methods need to be developed for assessing surface roughness from CT and
25 structured light data from AM surfaces. See also Post Processing section 2.2.3.4 gap P4.

30 Repair; ☐Data


5 Current Alternative: Ultrasonic and hall effect wall thickness measurements can be used for walls with
6 one external surface. Company specific internal procedures, as well as other existing standards and CT
7 software to determine dimensional accuracy of topology optimized complex geometry AM parts are
8 used.
10 ☐New
11 V3 Update: As noted in the text. Also, E1570 and E1695 are more general in their approaches and are
12 not specific to AM. There is guidance for testing; however, it does not provide a definitive method for
13 internal features.
14 2.4.5 Data Fusion

15 Data fusion in the NDT metrology world is defined as applying more than one NDT technique to provide
16 additional, complementary, or redundant information that can conform with the result. Data fusion
17 provides the ability to measure the same location from different viewpoints. This is needed because of
18 the complex geometry that might exist in AM parts. Setting this process up is not easy as it might require
19 a robotic-based or automated positioning system. One example of this methodology can be applying the
20 eddy current method to check surface detection, but then using ultrasonic methods to get volumetric
21 information. Combining the data sets from both will provide a simple, unified interpretation of results.
22 Data fusion also is used in a scenario where model-based inspection techniques for AM rely on the
23 combination of a number of different models and data sets to derive meaningful interpretation and
24 utility of the inspection results. NDE data plays an important role in product acceptance/rejection,
25 validation of simulation/predictive models, process improvement, and potentially process control.
26 Models include: the original part or feature model (either a surface or solid model); the build model to
27 include support structure, fixture, or base features (hybrid parts); and models or data sets associated
28 with NDE or metrology scans such as CT reconstructions and 3D and 2D feature maps. The orientation of
29 these data sets in a common frame of reference is critical to interpreting the differences and
30 relationship of the features. In one example, an as-built model calculated from a CT reconstruction may
31 be compared to an original part model to determine geometric fidelity, or how to orient the as-built part
32 to find the finished product within the near net shaped deposit. In another example, the finished part
33 model may be compared with the as-deposited model and the location of near surface defects, to
34 ensure adequate machining allowance is provided to remove the defects identified within an NDE-
35 generated data set. Thermomechanical simulation may be compared with as-built data sets, to derive
36 the character or location of distortion or feature resolution from form metrology methods.
1 No published standards exist but one standard in development is ASTM WK73978 New Specification for
2 Additive Manufacturing-General Principles-Registration of Process-Monitoring and Quality-Control Data
3 See gap DA9 (formerly NDE5) in section 2.6.3.1 Data Registration and Fusion.
4 2.4.6 NDE of Polymers and Other Non-Metallic Materials

5 For polymers, and other nonmetallic materials, the most common NDE methods recognized and
6 controlled by industrial standards are acoustic emission, computed tomography, infrared thermography,
7 leak testing, radiographic testing, shearography, spectroscopy (FTIR, Raman), strain measurement,
8 ultrasonic testing, and visual testing. ASTM E2533-21, Standard Guide for Nondestructive Testing of
9 Polymer Matrix Composites Used in Aerospace Applications, is valid for NDE of polymer matrix
10 composites (PMCs), and therefore has peripheral relevance to NDE of plastics used in AM [acrylonitrile
11 butadiene styrene (ABS), polycarbonate (PC), polylactic acid (PLA), nylon, polyaryl ether ketones (PEAK),
12 and polyetherimide (PEI)]. That said, AM plastic parts are expected to have similar characteristics to
13 PMCs; therefore, the same or similar NDE techniques might be applicable.
14 NASA-STD-6030 is applicable to mature AM polymeric materials (thermoplastic powder and filament

15 and SLA thermosetting resins), and processing technologies (powder bed fusion (PBF-LB), vat
16 photopolymerization (SLA), and material extrusion (FDM and FFF)). These materials and processes are
17 used in AM spacecraft parts with either nonnegligible (Class B) or negligible (Class C) consequence of
18 failure. Furthermore, while NDE is waived for Class C polymeric parts, Class B polymeric parts shall
19 receive NDE for process control with full coverage of the surface and volume of the part, with any
20 coverage limitations due to NDE technique(s) and/or part geometry documented. Lastly, it should be
21 noted that NDE of Class B parts for process control requires the use of physical reference standards for
22 calibration and acceptance criteria based on the capability of the NDE technique but does not require
23 quantitative validation of flaw detection, as would be the case for metallic Class A high consequence of
24 failure parts.
25 There are currently five categories used to create AM polymer parts. The categories are:
26  Powder bed fusion and sintering (PBF-LB, SLS)

27  Material extrusion (FDM, FFF, DWI)
28  Vat polymerization (SLA)
29  Material jetting
30  Sheet lamination
31
32 Some initiatives to be noted are:
33  NASA 6030 Additive Manufacturing Requirements for Spaceflight Systems covers non-metallic
34 parts and address NDE and physical-mechanical property testing.
35  CMH-17 Composite Materials Handbook, has an effort related to non-metallic NDE (composites)
36  NDE in Additive Manufacturing of Ceramic Components
37
2  ASTM WK85121, Nondestructive examination of polymeric and nonmetallic additively

3 manufactured parts after build
4
5 Gap NDE6: NDE of Polymers and Other Non-Metallic Materials. No published or in development
6 standards or specifications have been identified for NDE of polymers and other non-metallic materials.
8 R&D Expectations: Research who uses filaments, powder, or pellets with and without continuous fiber,
9 chopped fiber, and particle reinforcement. Of interest are low density, high specific strength plastics
10 used in secondary structural applications, and polymers with a high degree of fiber or particle loading in
11 applications requiring strength, toughness and low weight. Users and manufacturers of such materials
12 need to be surveyed to determine what requirements they are anticipating for NDE inspection of parts
13 made from polyetherimides (PEI), polyaryl ether ketones (PAEK), composite non-metallic AM parts (for
14 example, carbon-filled nylon), unfilled thermoplastics (ABS, PC, PLA, nylon, etc.), and SLA UV-curable
15 resins. Polymers such as Ultem® 9580 PEI, which is used in FFF/FDM parts (air ducts, wall panels, seat
16 frameworks) and is flame, smoke and toxicity (FST) compliant and has excellent specific strength are
17 noteworthy.
18 Recommendation: There is a need for an industry-driven standard led by NDE experts and supported by
19 the additive manufacturing community to assess current inspection practices and introduce NDE
20 inspection requirements for structural or load bearing polymers, composites, and other non-metallic
21 materials. Use ASTM E2533 as a starting point and guideline when applicable.
23 Organization: ASTM F42/ISO TC 261, ASTM E07, ASTM D20, ASME, SAE AMS AM

26 Repair; ☐Data

29 Material Type: ☐All/Material Agnostic; ☐Metal; ☒ Polymer; ☒Ceramic; ☒Composite

1 Current Alternative: Company specific internal methods
2 V3 Status of Progress: ☐ Green; ☐Yellow; ☐Red; ☒Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
3 New
4 V3 Update: See standards activities listed above.
5 2.4.7 NDE of Counterfeit AM Parts

6 To protect against counterfeit 3D parts, anti-counterfeiting methods are being developed for
7 components produced via AM. Nondestructive evaluation methods may be used in conjunction with
8 some anti-counterfeiting methods to verify product authenticity. AM-specific considerations for aligning
9 NDE with anti-counterfeiting include:
10  Using as-manufactured NDE data, especially for polymers, to establish a standard for later field
11 validation
12  Incorporate and keep current cybersecurity practices to manage the creation and storage of
13 NDE data used for anti-counterfeiting verification
14  Simple NDE methods that are compatible with decentralized inventory management enabled by
15 the AM manufacturing model.
16  Methods to detect covert markings
17
18 Best practices in other industries recognize the interplay between security and quality, address the
19 advantages of providing authentication options at multiple points in the supply chain and encourage
20 scalable approaches that make it difficult to counterfeit the anti-counterfeiting measures.33 An
21 Aerospace Industries Association (AIA) report covering counterfeiting recommended that standards in
22 the area of mechanical parts and materials be established.34
23 Anti-counterfeiting can be viewed as essentially an arms race with an economically-motivated foe that
24 aims to exploit a brand’s good name and a trusted maker’s quality procedures. Covert markings are
25 therefore preferable, since they delay notifying the counterfeiter that updates are needed. NDE is
26 particularly suited to AM protection, because:
27  NDE methods can detect subsurface, chemical, and other covert taggants, optimally quickly,
28 portably, and with minimal training
29  Affordable, scalable protections are more likely to be adopted, and anti-counterfeiting can,
30 optimally, align with existing NDE that is useful for quality monitoring. This alignment recognizes
31 that counterfeit detection is part of quality: a counterfeit part is a quality failure.
33
See for example Best Practices in the Fight Against Global Counterfeiting, published by ANSI in 2011.
34
See A Special Report Counterfeit Parts; Increasing Awareness and Developing Countermeasures, published by
AIA in March 2011.
1  AM’s smaller batch sizes and focus on customization limits the applicability of sampling; NDE
2 makes it possible to test the end product without sacrificing any units to destructive testing.
3  Distributed manufacturing empowers additional players as production sites. Inspecting and
4 certifying each site (and its suppliers) would introduce potentially crippling costs compared to
5 simply checking their output, both for quality and for the correct anti-counterfeiting marks,
6 using NDE.
7  NDE makes it possible to compare field-collected verification data (for a print) with a stored file
8 (for a correct, authorized version), so that trust can be established. This model can apply to
9 authorized repair parts printed as needed, or to point-of-care medical and pharmaceutical
10 printing, for example. In the latter case, the stored model and match requirements can be
11 complex, permitting only certain kinds of variation (size and shape; limited changes in dose or
12 ingredients such as adding flavor or removing allergens).
13
14 Potentially relevant published standards for general industry include:
15  ISO 22380:2018, Security and resilience — Authenticity, integrity and trust for products and
16 documents — General principles for product fraud risk and countermeasures
17  SAE AS5553D-2022, Counterfeit Electrical, Electronic, and Electromechanical (EEE) Parts;
18 Avoidance, Detection, Mitigation, and Disposition. SAE G-19 Counterfeit Electronics Parts
19 committees has a suite of standards which may be useful.
20  SAE AS6174A-2014, Counterfeit Materiel; Assuring Acquisition of Authentic and Conforming
21 Materiel
22
23 Much of the standards work on counterfeit electronic parts focuses on trust of upstream suppliers. AM’s
24 distributed nature, with many more players, further complicates supplier verification. Electronic parts
25 are a particularly difficult counterfeiting challenge because a part may function, but fail early.
26 Uncovering those uplabeled components is best accomplished via functional (electronic) testing, not
27 NDE. Including authentication marks or taggants on certified parts, and then using NDE to check for their
28 presence, is a possible workaround. For other AM products (metal, polymer, pharmaceutical), shape,
29 strength, and materials (including particle size and distribution) are the quality targets, all well suited to
30 NDE; in those instances, NDE can seamlessly test both for the presence of an authenticator and for other
31 quality elements.
32 Gap NDE7: NDE of Counterfeit AM Parts. There are no published or in development NDE standards for
33 methods used to verify anti-counterfeiting methods.
35 R&D Expectations: Future R&D may be needed if an anti-counterfeiting method is developed which
36 cannot be verified by existing NDE methods or standards.
1 Recommendation: Develop NDE methods and standards for anti-counterfeiting that are not addressed
2 by existing methods or standards. See also sections 2.1.7 Design for Anti-counterfeiting (gap DE29);
3 2.2.2.13 Anti-counterfeiting (process control); and 2.4.2 gap NDE2.
5 Organization: ASTM F42/ISO TC 261, ASTM E07, SAE AMS-AM

8 Repair; ☐Data


18 ☐New
19 V3 Update: ISO 22380 has been published and SAE AS5553B has been revised, the current edition, D,
20 was approved in 2022.
21 2.4.8 NDE Acceptance Criteria for Fracture Critical AM Parts

22 In general, fracture critical AM hardware (such as flight hardware) requires comprehensive volumetric
23 and surface NDE to ensure the hardware is acceptable for use. Since the first release of the roadmap in
24 2017, NDE community has been learning what works and what does not when inspecting high value and
25 limited production run flight hardware. For example, penetrant inspection of the part’s surface requires
26 surface preparation that may depart from normal post-processing. For volumetric inspections, radiation
27 or ultrasound are transmitted through AM structures using the same inspection procedures developed
28 for conventional welded and wrought products, which may yield results not tailored to AM.
29 Consequently, most of the acceptance criteria for AM parts are derived from inspection of product
30 forms produced using materials and processing developed outside of the AM community. The question
31 then becomes whether AM parts are being inspected and accepted with the appropriate level of rigor
32 and conservatism so that risks associated with the use of newer AM processes are mitigated.
1 New industry-based acceptance criteria are needed for AM parts. These acceptance criteria may be
2 based on criticality, loads and environments, safety, consequence of failure, or NDE inspectability. In
3 addition to practical and meaningful acceptance criteria, a deeper understanding is needed involving
4 determination of the role specific types of AM defects play in part failure (see gap NDE9). A lot of
5 framework must be developed so that appropriate industry-based acceptance criteria can be
6 implemented. Towards this goal, harmonized defect terminology must first be adopted (see gap NDE1).
7 Second, because of the need to have high quality parts in fracture critical applications that are relatively
8 defect-free and have a low probability of failure, the industry must lay the groundwork to allow the
9 production of parts using qualified material processes in which the defect state is known, reproducible,
10 and controlled. Third, given the need to mitigate the higher risk associated with the use of newer AM
11 parts due to the presence of unique flaw types at sizes and distributions for which little engineering
12 experience exists, there is a need to develop sensitive NDE methods such as micro-CT, or whole-body
13 resonance methods such as PCRT, so that fracture critical AM parts can be adequately screened before
14 acceptance. For example, the high usage and reliance on micro-CT to detect and characterize small
15 defect sizes (< 100 m) in fracture critical metal AM parts is prevalent in NASA, the DOD, and elsewhere
16 in the aerospace industry. These factors entail the adoption of acceptance criteria with the appropriate
17 level of conservatism so that all relevant flaws are detected.
18 Towards this goal, an ASTM WK75329 Standard Practice for the Nondestructive Testing (NDT),
19 Inspection Levels and Acceptance Criteria for Parts Manufactured with Laser Based Powder Fusion has
20 been in work and expected to be balloted in 2023. This practice provides two NDE inspection levels
21 (Level I and II) for metal PBF-LB parts and lists acceptance criteria and applicable NDE methods. Three
22 defect types considered that are unique to PBF-LB:
23 1) lack of fusion porosity

24 2) keyhole porosity
25 3) trapped powder
26
27 Level I NDE, which is more comprehensive consists of CT, PCRT, PT, RT, UT, and VT, while Level II NDE
28 consists of PCRT, PT, and VT. The practice is not based on part-driven engineering criteria but on the
29 practical inspection capability of the applied NDE methods.
30 In the application of NDE, the types of defects that are applicable to the AM process must be matched
31 to the appropriate NDE method. Such matching guidance appears in ASTM E3166-20e1 (Table 2) and in
32 ISO/ASTM DTR 52905 (Table 3). There are longstanding NDE standard defect classes for welds and
33 castings with matching NDE methods. The defects characteristic to these processes may not be
34 applicable to the AM process. Welding flaw types have been identified specifically for use such as
35 electron-beam welding for fatigue critical applications. A possible approach is to define allowable
36 defects as shown in SAE AMS2680C-2019, Electron-Beam Welding for Fatigue Critical Applications.
37 Discontinuity limits could be approached (developed) for each AM process where flaws may be slightly
38 different, e.g. PBF-LB, DED-LB. This implies that until an accepted defects catalog and associated NDE
1 detection limits for defects are established, the NDE techniques and acceptance criteria may remain
2 part-specific point designs.
4  AWS D20.1/D20.1M:2019 Specification for Fabrication of Metal Components Using Additive

5 Manufacturing
6  NASA-STD-6030 Additive Manufacturing Requirements for Spaceflight Systems Section 4.8
7 provides guidance for NDE with full coverage of surface and volume of the part including
8 verifiable detection of critical initial flaw size and fracture critical damage tolerant parts
9 performed on Class A and B parts including the concept of AM risk is introduced, which governs
10 the quantitative NDE performed for a given part. See also NASA-STD-5009, Nondestructive
11 Evaluation Requirements for Fracture Critical Metallic Components
12
14  ASTM WK75329, Practice for Nondestructive Testing (NDT), Part Quality, and Acceptability
15 Levels of Additively Manufactured Laser Based Powder Bed Fusion Aerospace Components (in
16 development under F42.07)
17  ASTM WK75584 Standard Test Method for Additive Manufacturing Non-destructive testing and
18 evaluation of fatigue cracks using tensioned computed tomography (in development under
19 F42.01)
20  ASTM WK76038 Standard Test Method for Additive Manufacturing of Metals -- Non-destructive
21 testing and evaluation -- Porosity Measurement with X-ray CT (in development under F42.07)
22
23 Gap NDE8: NDE Acceptance Criteria for Fracture Critical AM Parts. There is a need for an industry
24 standard that establishes NDE acceptance criteria and classes for fracture critical AM production parts.
25 The classes could be based on:
26 1) fracture criticality (NASA-STD-5009)

27 2) consequence and likelihood of failure (NASA-STD-6030)
28 3) design loads (JAXA and LMCO)
29 4) NDE inspection capability (ASTM WK75329)
30 5) other factors such as mission or safety criticality
31 Potential stakeholders are NASA, its international space partners, the aerospace industry, the
32 commercial aviation industry, the FAA, the DoD, the DOE (for example, the NRC), the nuclear industry,
33 or any entity that produces or uses fracture critical AM hardware.
35 R&D Expectations: This gap interfaces with gap NDE9 described in Section 2.4.9 and focuses on the
36 acceptance of AM production parts destined for service. Acceptance consists of NDE of production parts
1 or components. It is anticipated that parts will be made using optimized processes (for example, NASA-
2 STD-6060 qualified material processes), which contain minimal or otherwise controlled loadings of
3 technologically important AM defects. These in-family parts will then be compared to out-of-family
4 parts, which either contain excessive loadings of technologically important AM defects, or have been
5 made with questionable feedstock, or have been subjected to a known process anomaly, thus
6 compromising their acceptance and subsequent use in service. Research can then focus on identifying
7 what feedstock or process (or post-process) conditions led to nonconformance and out-of-family
8 behavior. The role of NDE will be to distinguish between in-family (nominal) versus out-of-family (non-
9 nominal) production parts possessing different characteristic damage states. For example, one of the
10 key questions to answer would be to determine which process variable(s) are relevant and have the
11 greatest effect on the performance of the part. Also, the type of scanning (i.e., X-ray radiography, CT,
12 micro-CT, PCRT) relative to the material type/thickness and design complexity of the part should be
13 considered.
14 Recommendation: Develop an industry standard that establishes different acceptance classes and NDE
15 acceptance metrics for high fidelity of finished production parts and components depending on
16 feedstock, and process (or post-process) conditions. The acceptance metrics (criticality, consequence
17 and likelihood of failure, loads, etc.) are expected to be industry specific (aerospace, medical, energy
18 sectors). Part and component level NDE inspections may be corroborated with effect-of-defect coupon
19 (or witness specimen) level testing described in gap NDE9 using specimens that have the appropriate
20 level of fidelity, i.e., sufficient similarity between the defect state and mechanical response in sacrificial
21 samples (for example, ASTM E8 compliant dog bones, and witness coupons showing the same level of
22 defects) with natural flaws in actual production parts.
23 Priority: ☒High; Medium; ☐Low
24 Organization: ASTM F42 / ISO TC 261 JG 59, ASTM E07, ASTM E08 on Fracture and Fatigue

27 Repair; ☐Data


34 ☐Personnel/Suppliers; ☐Other (specify)
2 ☐New
3 V3 Update: AWS D20.1 contains acceptance criteria but is also planning to address internal flaws
4 matched with surface finish for fatigue applications. ASTM WK75329 will be a standard practice for NDE
5 of PBF-LB aerospace components, establishing NDE acceptance classes and acceptance criteria. The
6 criteria are based on the practical limits of NDE technology, not effect-of-defect.
7 2.4.9 Effect-of-Defect of Technologically Important AM Defects

8 As noted in Section 2.4.8 on Acceptance Criteria, fracture critical metal AM hardware (such as a high
9 consequence of failure flight hardware) requires comprehensive volumetric and surface NDE to ensure
10 the hardware is acceptable for use. To quantify the risks associated with the part and to demonstrate
11 acceptable damage tolerance, it is incumbent upon the structural assessment and fracture and fatigue
12 communities to define critical initial flaw sizes (CIFS) for the part to define the objectives of the NDE.
13 Knowledge of the CIFS will allow the NDE and fracture control community to evaluate risks and
14 communicate meaningful recommendations regarding the acceptability of the risk.
15 In NASA-STD-6030, high-risk, high consequence of failure parts are categorized as Class A parts. Implicit
16 in NASA’s Class A-B-C formalism is the ability to:
17 1) detect flaws that bracket the critical initial flaw size at a requisite reliability (e.g., 90/95 POD)
18 2) detect flaws that are relevant (i.e., effect on finished part performance has been demonstrated)
19 3) detect flaws that are unique to AM for which engineering experience is lacks.
20
21 Similar considerations might be for non-fracture critical AM parts that have a nonnegligible consequence
22 of failure. For example, such parts might be used in applications are that are safety and mission critical,
23 and may include both polymeric and metallic AM hardware. In NASA-STD-6030, such parts are
24 categorized as Class B parts. Like Class A parts, Class B parts also require comprehensive volumetric and
25 surface NDE to ensure the hardware is acceptable for use. However, the requirement to detect flaws at
26 a requisite reliability is waived, for example, 90/95 POD as levied by NASA-STD-5009 is not imposed.
27 Instead, in the case of ASTM WK75329, acceptance criteria are based on the practical limits of NDE
28 technology, not knowledge of the CIFS, fracture mechanics, reliability of the NDE, or effect-of-defect.
29 However, an important caveat exists for non-fracture critical Class B parts that cannot be ignored.
30 Namely, the effect-of-defect is currently unknown for technologically important flaws unique to AM
31 such as:
32 1) lack of fusion porosity

33 2) keyhole porosity
34 3) trapped powder
35
36 In this case, it is premature, therefore, to conclude flaws of a given type and size are irrelevant and thus
37 do not need to be detected.
1 To rectify this situation, this gap implements guidance to prepare subscale test specimens that allow the
2 effect of technologically important defects on relevant end-use properties to be determined. Contrary
3 to gap NDE8, which is applied to production parts, gap NDE9 investigates the effect-of-defect using
4 representative, subscale coupons (or witness specimens). This allows a direct cause-and-effect
5 relationship to be established between processing (and/or post-processing), the resulting defect state,
6 and end-use properties, thus establishing succinct process-structure-property relations for specific
7 defects. Important questions such as whether defects can be healed through hot isotactic pressing (HIP)
8 or heat treatment can also be examined if needed.
9 To obtain meaningful results, control coupons (or witness specimens) are made using the same
10 materials and processes as used for high fidelity or finished production parts and components. The
11 defect state is then intentionally altered using guidance in ISO/ASTM TR 52906-EB. The coupons and
12 subscale test specimens so obtained can possess a range of defect states. To facilitate ensuing NDE
13 inspections and destructive tests (T&I), the specimens called out in this standard are fabricated in the
14 form of standard test specimens for tensile testing (ASTM E8, D638, D5766, D6742), compressive testing
15 (ASTM D395), fatigue life (ASTM E466, E606), fracture toughness (ASTM E399, E1820), etc., as outlined
16 in Tables 13 through 16 in NASA-STD-6030. For a given defect or characteristic defect state great care
17 must be taken to ensure the effect-of-defect exhibited by coupons and subscale test specimens is
18 representative of the effect-of-defect exhibited by the production part of interest. To accomplish this,
19 coupon or subscale test specimen data should be verified or augmented by production part data when
20 doubts of equivalency exist.
22  NASA-STD-6030, Additive Manufacturing Requirements for Spaceflight Systems Section 4.8

23 provides guidance for NDE with full coverage of surface and volume of the part including
24 verifiable detection of critical initial flaw size and fracture critical damage tolerant parts
25 performed on Class A and B parts including the concept of AM risk is introduced, which governs
26 the quantitative NDE performed for a given part. While the NDE approach used for fracture
27 critical (Class A) parts covered by gap NDE8 must follow the intent of NASA-STD-5009 towards
28 meeting a 90/95 POD requirement, this standard instead focuses on effect-of-defect.
29  ISO/ASTM TR 52906-EB, Additive Manufacturing—Nondestructive Testing—Intentionally
30 Seeding Flaws in Metallic Parts
31
32 Published standards for fracture control of metals (currently agnostic to AM):
33  NASA-STD-5009, Nondestructive Evaluation Requirements for Fracture Critical Metallic

34 Components
35
1  ASTM WK75329, Practice for Nondestructive Testing (NDT), Part Quality, and Acceptability
2 Levels of Additively Manufactured Laser Based Powder Bed Fusion Aerospace Components (in
3 development under F42.07)
4
5 New Gap NDE9: Effect-of-Defect of AM Defects Detectable by NDE. There is a need for an industry
6 standard to determine the effect of technologically important flaws unique to AM, which are considered
7 to relevant and have a significant effect on end-use properties. Contrary to gap NDE8, which uses
8 acceptance criteria based on NDE capability developed for production parts or components, gap NDE9
9 investigates the effect-of-defect at the coupon level (or witness specimen level). Direct cause-and-effect
10 relationships between process (and/or post-processing), the resulting defect state, and final properties
11 is established (process-structure-property relationship). Important questions such as whether defects
12 can be healed through hot isotactic pressing (HIP) or heat treatment can also be examined if necessary.
13 Questions about equivalency between subscale and production parts can be accomplished by verifying
14 or augmenting subscale part with production part data.
15
16 To obtain meaningful results, control coupons (or witness specimens) are made using the same
17 materials and processes as used for the production part. The defect state is then intentionally altered
18 using guidance in ISO/ASTM TR 52906-EB. The specimens so obtained will possess a range of defect
19 states, which will be characterized by NDE. The specimens called out in this standard can be fabricated
20 in the form of standard test specimen geometries for tensile testing (ASTM E8, D638, D5766, D6742),
21 compressive testing (ASTM D395), fatigue life (ASTM E466, E606), fracture toughness (ASTM E399,
22 E1820), etc., as outlined in Tables 13 through 16 in NASA-STD-6030.
24 R&D Expectations: A multidisciplinary effort is needed encompassing feedstock selection, AM

25 processing and post-processing, NDE, and physical and mechanical property testing. Coupons (or
26 witness specimens) are made at one or several manufacturers are analyzed by NDE and finally by
27 destructive testing (mechanical and physical property testing). Round robin testing following the outline
28 of than ASTM interlaboratory study (ILS) would be ideal subscale test coupons are interrogated by NDE
29 at several labs to assess NDE reproducibility and repeatability and leading to NDE Precision and Bias
30 statements. This gap interfaces and with proper coordination can be combined with gap NDE8 by
31 fabricating witness coupons at the same time as production parts. The coupon-level test specimens
32 fabricated by this standard will contain controlled loadings of technologically important AM defects,
33 which are then used to determine the effect-of-defect in order to assess relevance or nonrelevance. The
34 relevance of flaw type, size and distribution as characterized by NDE is compared to part performance as
35 indicated by mechanical and physical property test results. The goal thus is to develop acceptance
36 criteria based on knowledge of the characteristic defect state rather than on NDE reliability and fracture
37 mechanics and has application to both metallic and polymeric (including composite) AM parts.
1 Recommendation: Develop an industry standard that allows fabrication of subscale test specimens
2 (standard test coupons) that directly link the characteristic defect state with end-use performance
3 properties such as strength, modulus, fracture toughness, and part density.
4 Priority: ☐High; ☒ Medium; ☐Low
5 Organization: ASTM F42 / ISO TC 261 JG 59, ASTM E07 on NDT, ASTM E08 on Fracture and Fatigue,
6 NASA

9 Repair; ☐Data


16 ☐Personnel/Suppliers; ☐Other (specify) ☒Test coupons and artefacts
19 ☒New
20 2.4.10 In-Service NDE

21 2.4.10.1 In-service Inspection
22 A key step in using AM-fabricated components will be the assurance that safety-critical components
23 meet the quality and performance requirements of the industry and regulatory authorities throughout
24 the components’ lifetime. In-service inspection refers to the periodic inspection of components that
25 have already been placed into service to monitor flaw initiation and growth. AM materials provide
26 unique in-service inspection challenges. For example, porosity, grain microstructure, and surface
27 roughness are common issues with AM components, and there is a lack of data on the effects of these
28 issues on conventional nondestructive test methods such as ultrasonic (signal-to-noise, scatter, and
29 attenuation come into play), eddy current testing, and radiographic testing. The nuclear sector primarily
30 uses ultrasonics for volumetric inspections and eddy current for surface inspection of the heat exchange
31 tubing. As industries progress toward the use of AM-built components, the inspection capabilities to
32 monitor the safety and integrity of these components need to be effective and reliable.
1 Issues such as critical flaw types, critical flaw sizes, flaw locations, and degradation mechanisms need to
2 be understood so that appropriate NDE methods can be implemented, adapted, or developed. Research
3 is needed to demonstrate that NDE can identify the critical flaws early enough so that mitigating action
4 can be taken. Also, AM components may have complex geometries that will challenge existing NDE
5 approaches, so new inspection approaches may be needed such as whole-body resonance approaches.
6 Design of AM components where NDE inspectability is factored into early design phases to facilitate
7 detection of critical flaws throughout the service life at the critical location, size, and distribution is also
8 expected to play a role.
10  ASME BPVC-XI-1 – 2021, Rules for Inservice Inspection of Nuclear Power Plant Components
11  ASTM E3213-19, Standard Practice for Part-to-Itself Examination Using Process Compensated
12 Resonance Testing Via Swept Sine Input for Metallic and Non-Metallic Parts (E07.06)
13
14 No in-development standards have been identified.
15
16 New Gap NDE10: In-service Inspection. No published or in-development standards have been identified
17 for in-service inspection of safety-critical AM components.
19 R&D Expectations: R&D is needed to demonstrate which in-service NDE methods or techniques can
20 identify critical flaws in safety-relevant AM components. Prior to implementing in-service NDE, critical
21 flaw types and locations should be identified in addition to degradation mechanisms. The effects of
22 material microstructure and geometry should be explored. New or emerging NDE techniques, such as
23 ultrasonic full matrix capture, targeted micro-CT, and PCRT, may need to be tested. An increased
24 understanding about how surface finish issues common with additive parts would affect eddy current
25 measurement states is needed.
26 Recommendation: Develop standards for in-service inspection of AM components. Standards may

27 describe issues including, but not limited to, what types of flaws to look for, where critical flaws might
28 occur (i.e., the relevant inspection volume), how critical flaws might propagate (i.e., rates of
29 propagation, degree of branching), the level of component surface finish that is needed, methods for
30 inspecting complex geometries, and guidelines for reference mockups and standards. It is recommended
31 that exemplar AM components used in critical applications (nuclear, aerospace, and/or medical) that
32 present unique NDE inspection challenges will be fabricated with known relevant flaws (e.g. porosity)
33 and distributed to stakeholders in a round robin study conducted over the course of a component’s life
34 cycle. For example, components with accumulated service as measured by time and number of cycles
35 would be inspected at intervals characteristic of 1) post—fabrication/pre-installation (new or early life),
36 2) periodic-remove and inspect (mid-life), 3) decommissioning/component replacement (near end-of-
37 life), and 4) ultimate failure (end-of-life).
2 Organization(s): ASME, ASTM

5 Repair; ☐Data
6 Sectors: ☐All/Sector Agnostic; ☒Aerospace; ☐Automotive; ☒Construction; ☒Defense; ☐Electronics;

7 ☒Energy; ☒Medical; ☒Spaceflight; ☒Other (specify) Nuclear
10 Extrusion;☐Material Jetting; ☐Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photopolymerization

13 Current Alternative: Use existing in-service inspection standards developed for non-AM parts and
14 materials.
16 New
17 Other Nondestructive Evaluation (NDE) Standards Activity Since Roadmap v2 - Relevance to

20 No additional published standards were identified.
22  AMPP TR21522, Corrosion Testing for Additive Manufacturing. Laura Feix, AMPP, reports that
23 target date for balloting is in Q2 of 2023. Five sub-teams are conducting literature surveys in the
24 areas of Corrosion Resistance, Corrosion Fatigue, Environmental Cracking (SSC/SCC), Hydrogen
25 Related (HISC, SWC & HIC) and High Temperature Oxidation. See more at Q&C Section 2.3.3.6.1.
1
2
3
4
5
6
7
8
9
1 2.5 Maintenance and Repair
3 Maintenance
4 For purposes of this discussion, “maintenance” is defined as encompassing maintenance of AM

5 machines; condition-based maintenance (CBM)35 as it relates to the use of metal and polymer AM
6 processes and equipment; level of repair analysis (LORA)36 and reliability centered maintenance (RCM)37
7 analysis of AM parts, tools, and equipment; training of maintenance personnel; and maintenance
8 inspection of AM machines.
9 Additive Repair
10 Additive repair processes apply exclusively to metal components and refer to processes used to add or
11 build up material onto a substrate. The repaired surface(s) and component are then returned to the as-
12 designed condition by subtractive manufacturing methods. Additive repair processes in current use
13 include blown metal powder systems and hybrid (additive + subtractive) systems. For some applications,
14 metal cold spray processes (high pressure cold spray systems) can be used to add metal to an existing
15 surface for structural purposes. Other aspects of additive repair include: requirements for metal powder
16 used for additive repair, surface preparation requirements, qualification and certification of the repair
17 process, and inspection of repairs performed with AM technology. There are currently no materials,
18 processes or equipment that are used to additively repair polymer AM parts.
19 Tools and Tooling
35
Conditioned Based Maintenance: Performing Maintenance based on Need (i.e., based on the Condition or
Health of a component or system rather than on a periodic or scheduled basis). Source: ARP6461, Guidelines for
Implementation of Structural Health Monitoring on Fixed Wing Aircraft. The purpose of Condition Based
Maintenance (CBM) is to reduce the maintenance and life-cycle costs by using a proactive strategy of performing
maintenance based on evidence of need. That is contrasted with Interval Based Maintenance, where the action is
performed at a set interval (measured by time, mileage or some other metric). Source: SAE TAHB0009, Reliability
Program Handbook
36
Level of Repair Analysis (LORA): An analytical methodology used to assist in developing maintenance concepts,
influencing design, and establishing the maintenance level at which components will be replaced, repaired, or
discarded based on economic/noneconomic constraints and operational readiness requirements. Source: AS1390,
Level of Repair Analysis (LORA)
37
Reliability Centered Maintenance (RCM) is a logical, structured framework that leverages reliability assessment
activities to determine the optimum mix of applicable and effective maintenance activities needed to sustain the
desired level of operational reliability of products/systems while ensuring their safe and economical operation and
support. Source: SAE TAHB0009, Reliability Program Handbook
1 As more fully described below, tools and tooling refer to creation or repair of those artifacts needed to
2 execute a parts repair and/or remanufacture for the purposes of scheduled maintenance or general
3 upgrade/overhaul. Tools and tooling as applied here may also include molds and dies that are
4 manufactured using AM processes. Tools refer to those parts and assemblies designed and
5 manufactured by AM processes and used to support the manufacture and/or repair of aerospace,
6 energy, industrial, medical, and other sectors’ equipment and systems. Tooling refers to those parts that
7 are designed and manufactured by AM processes and used to make the end use parts that become part
8 of the aircraft itself (or the industrial or aerospace equipment and systems).
9 2.5.2 Maintenance and Sustainment of Machines

10 Manufacturers have prescribed methods for maintenance of their particular additive machines. The
11 intent of focusing on this area is not to circumvent manufacturer-recommended machine maintenance
12 practices, but to establish boundaries for standardization of the various maintenance activities that may
13 be unique to AM machines whether the machines are used to produce metal AM or polymer AM parts.
14 These may include for example:
15  Facility requirements that will provide for future maintenance of the AM machines including but
16 not limited to: electrical power supply requirements; power conditioning requirements; standby
17 power requirements or recommendations; water availability and quality or filtration
18 requirements; structural requirements for supporting the AM machine; lighting; limits on
19 temperature and humidity where the AM machine is installed; and distance from machine to
20 wall of room (required to support maintenance, air flow, people, etc.)
21  Safety overviews
22  Skill set required to perform maintenance on AM machines
23  Training of maintenance personnel
24  Documentation of AM maintenance programs
25  Hazardous materials related to AM machines
26  Software maintenance and cybersecurity related to AM machines
27 SAE committee G-41 Reliability standards portfolio has several resources but they are more broadly
28 applicable and not specific to AM.
29
31  IEC 60300-3-11:2009 Dependability management - Part 3-11: Application guide - Reliability

32 centred maintenance (IEC TC 59) but is not specific to AM.
33  ISO 17359:2018 Condition monitoring and diagnostics of machines — General guidelines (TC 108
34 / SC 5)
35  ISO / ASTM 52941: 2020 Additive manufacturing — System performance and reliability —
37 aerospace application (Aerospace PBF) defines relevant testing.
38  SAE JA1012: 2011, A Guide to the Reliability-Centered Maintenance (RCM) Standard (2011-08-
39 22)
1  SAE JA1011: 2009, Evaluation Criteria for Reliability-Centered Maintenance (RCM) Processes
2 (2009-08-26)
3  SAE AMS7032 Machine Qualification for Fusion-Based Metal Additive Manufacturing (2022-08-
4 17)
5
6 Gap M1: AM Analyses in RCM and CBM. With respect to maintenance and sustainment of AM
7 machines, standards for AM analyses in Reliability Centered Maintenance (RCM) and Conditioned Based
8 Maintenance (CBM+) are needed.
11 Recommendation: Update SAE JA 1012-2011, a guide to provide analytics for AM trade-offs in RCM and
12 CBM+.
14 Organization: SAE, ISO, ASTM

17 Repair; ☐Data


25 Current Alternative: OEM preventative maintenance requirements outlined in maintenance manuals.
27 ☐New
28 V3 Update: SAE G-11M, Maintainability, Supportability and Logistics Committee, will consider inclusion
29 of analytics for AM trade-offs in the next update of JA1012.
30
1 See also gap PC2 on machine calibration and preventative maintenance, and gap PC14 on environmental
2 health and safety issues and protection of AM machine operators.
3 2.5.3 Standard Repair Procedures

4 AM technology for sustainment-related repairs can provide faster solutions to obsolescence and
5 diminishing sources of supply due to the large quantity of systems, subsystems, parts and tooling that
6 are no longer available or manufactured, or where no data exists. It has the potential to provide relief to
7 weapon systems support required in the field by providing on-site repair capability. Materials are a
8 factor since there are several types of powder metal materials that can be used. Different powders can
9 be engineered for each application, operational load spectrum, and standards should be established for
10 the AM repair industry (see gap PM7). Other factors to be addressed in the use of AM processes to
11 repair end use parts or tooling include:
12  Qualification and certification of the repair, including inspection of repairs (See also Q&C section
13 of this roadmap.)
14  Standard cleaning, and handling to prepare surfaces for adding material
15  The urgency of the maintenance required, e.g., requiring creation of a missing tool using
16 additive technology
17  Trade space related to different levels of repair and methods for accomplishing similar repairs
18 using traditional technologies and AM, e.g., relating to Life Cycle Cost (LCC)38 Analysis, LORA, and
19 RCM39
20  Reverse engineering of legacy parts (2D drawing conversion to 3D model) for AM tool path
21 generation; dimensional measurement during AM repair development and post inspection; and
22 load/stress analysis substantiation.
23  Development of test plans and specifications to qualify an organization’s use of an additive
24 repair process, including acceptance criteria.
25  Adaptation of existing standards requirements into the development of qualification test plans
26 and specifications.
28  ASME B107 series of standards (B107.100; B107.14M; B107.17; B107.300; B107.4; B107.400;
29 B107.410; B107.500; B107.56; B107.600)
38
Life Cycle Cost (LCC): Life Cycle Cost consists of research and development (R&D) costs, investment costs,
operating and support (O&S) costs, and disposal costs over the entire life cycle of a product. Source: AS1390, Level
of Repair Analysis (LORA)
39
“Trade space” refers to an aspect of analysis where variables are introduced to allow for alternate solutions to
be developed and compared. Amending doctrine on LCC Analysis, LORA, and RCM will allow for new variables to
be analyzed.
1  AWS B2.1/B2.1M:2014-AMD1, Specification for Welding Procedure and Performance
2 Qualification, which also has published errata (see document page).
3  AWS D17.1/D17.1M:2017-AMD2, Specification for Fusion Welding for Aerospace Applications
5 Manufacturing
6  ISO 15609-1:2019, Specification and qualification of welding procedures for metallic materials -
7 Welding procedure specification - Part 1: Arc welding (TC 44 / SC 10)
8  Metallic Materials Properties Development and Standardization Handbook (MMPDS), (2017-07)
9  MIL-STD-3021_CHG-2, Department of Defense Manufacturing Process Standard: Materials
10 Deposition, Cold Spray (2015-03-04)
11  MIL-STD-3049-CHG-1, Department of Defense Manufacturing Process Standard: Materials
12 Deposition, DDM: Direct Deposition of Metal For Remanufacture, Restoration And Recoating
13 (2014-01-10) on DED metal remanufacture/restoration
14  SAE AMS2680C-2019, Electron-Beam Welding for Fatigue Critical Applications (2019-01-14)
16  SAE AS1390A, Level of Repair Analysis (2014-04-15) provides a framework for evaluating
17 cost/benefit analysis of repairing a part versus replacing it.
18  SAE AMS2680C, Electron-Beam Welding for Fatigue Critical Applications (2019-01-14)
19  SAE TA-STD-0017A, Product Support Analysis, which is a partnering document to AS1390A.
20 (2022-03-01)
21  SAE AMS-AM, Additive Manufacturing Repair for Aerospace Applications
22
23 Gap M9: Laser Based Additive Repair. Current standards do not specifically address the use of laser-
24 based systems (metal powder or wire feedstock) to additively repair parts or tools.
27 Recommendation: Ensure that laser based additive repair processes are included in AWS D20.1 and SAE
28 AMS-AM Additive Repair for Aerospace Applications.
30 Organization: AWS, SAE AMS-AM

33 Repair; ☐Data
6 Q&C Category: ☐Materials; ☒Processes/Procedures; ☒Machines/Equipment; ☒Parts/Devices;

8 Current Alternative: Qualifying repair documents provided to customers.
10 ☐New
11 V3 Update: AWS D20.1 contains requirements for qualifying wire-fed and powder-fed laser DED
12 procedures. In paragraph 5.2.3.2, AWS D20.1 requires that tension test specimens that include the
13 material interface in the gage region be removed from procedure qualification builds used to qualify
14 repairs.
15 SAE’s AMS-AM Additive Manufacturing Committee established the Additive for Repair Working Group in
16 September 2018. Currently developing a scenario to establish the specification framework utilizing a
17 damaged airframe component requiring a directed energy deposition repair. Once finalized, the working
18 group plans to develop material and process specifications for aerospace repair applications.
19 2.5.4 Standard Technical Inspection Processes

20 Physical inspection of parts and tools/tooling requires a standardized assessment of defects, including
21 corrosion, abrasion/wear, cracks/fractures, and the suitability of additive manufacturing technologies as
22 a corrective repair action for such defects. Standard inspection procedures provide guidance to
23 maintainers to schedule preventative maintenance tasks, prioritize part or tooling defect cases, assess
24 risks, determine corrective action measures, and determine repair vs. remanufacture from a technical
25 feasibility and cost standpoint. Standard inspection procedures do not adequately consider the viability
26 of additive manufacturing technologies for preventative and corrective maintenance actions. Inspection
27 tools and procedures include:
28  Visual inspection
29  Magnetic particle inspection
30  Fluorescent and liquid penetrant inspection
31  Computed tomography (CT) scan
32  Radiography/X-ray inspection
33  Acoustic emission
1  Model-based inspection (e.g., 3D scanning) covered more in the next section
2  Ultrasonic inspection
3  Preventative maintenance scheduling
4  Risk assessment
5  Part condition categorization
7  ASTM E1742/E1742M-18, Standard Practice for Radiographic Examination (2018-03-21)

8  ASTM E1444/E1444M-22a, Standard Practice for Magnetic Particle Testing (2022-07-11)
9  SAE JA1011, Evaluation Criteria for Reliability-Centered Maintenance (RCM) Processes (2019-08-
10 26)
11  SAE JA1012, A Guide to the Reliability-Centered Maintenance (RCM) Standard (2011-08-22)
12  SAE AS1390A, Level of Repair Analysis (2014-04-15)
13 No standards in development have been identified.
14 Gap M4: Physical Inspection of Parts Repaired Using AM. A standard inspection process for component
15 or tooling defects is needed to consider additive manufacturing technologies as potential solutions for
16 preventative and corrective maintenance actions.
19 Recommendation: Update SAE JA1011/1012 to include an inspection process for additive

20 manufacturing repairs.
22 Organization: ASTM, ISO, SAE

25 Repair; ☐Data

3 Current Alternative: Existing inspection methods being used to determine if it still meets the original
4 requirements of the original part.
6 ☐New
7 V3 Update: SAE G-11M, Maintainability, Supportability and Logistics Committee, will consider inclusion
8 of an inspection process for AM repairs in the next update of JA1011 and JA1012.
9 2.5.5 Model-Based Inspection

10 Model-based inspection methods and tools, including 3D scanning, can be used to assess the level of
11 damage or nonconformance of material and provide insight into repairs necessary to restore parts to
12 ready-for-issue condition. The model used to assess the level of repair could be used to support the
13 business case for repair via AM, remanufacture via AM, or scrapping the part. Currently, model-based
14 inspection tools including 3D scanners and coordinate measuring machines (CMM) are used by
15 maintainers to measure tolerances of parts and level of damage for used components. Model-based
16 software tools can enable automated inspection routines for repeatability.
17 Model-based inspection, including 3D scanning, offers NDI for both end-use parts and AM machines.
18 Models can be utilized to assess level of damage for used components and assess the “health” of the
19 AM machine itself. Digital models can provide a cost-effective approach to assess level of damage and
20 provide predictive analytical models to monitor AM machine performance for maintenance scheduling.
22  ASME Y14.41-2019, Digital Product Definition Data Practices

23  ISO 16792:2021, Technical product documentation — Digital product definition data practices
24  ISO/IEC 23510:2021, Information technology — 3D printing and scanning — Framework for an
25 Additive Manufacturing Service Platform (AMSP) focuses on operational aspects.
26  QIF 3.0:2018, Quality Information Framework (QIF) (free download)
27 Gap M5: Model-Based Inspection. Standard practices for model-based inspection methods using AM
28 are needed for repair assessments and scheduling.
31 Recommendation: Develop standard practices for assessing level of damage for end-use parts.
1 Organization: ASME, ISO/ASTM, Dimensional Metrology Standards Consortium

4 Repair; ☐Data


12 Current Alternative: Existing inspection methods being used to determine if it still meets the original
13 requirements of the original part.
15 ☐New
17 2.5.6 Standards for Tracking Maintenance Operations

18 Maintenance tracking for AM machines is used to facilitate the management and organization of a
19 maintenance operation. Maintenance actions that are tracked include: routine maintenance,
20 preventative maintenance, work order maintenance, and breakdown maintenance. Maintenance
21 tracking can require a computerized maintenance management software (CMMS) tool. Tracking
22 maintenance operations is important to:
23  Ensure readiness of the system by tracking part maintenance

24  Evaluate and implement new technologies
25  Collect data for metrics
26  Develop information from collected data for prognostics and spares estimations
27  Verify spare parts inventories control and management
28  Verify skills requirements
29  Track time to repair
30  Ensure optimized use of budget for parts and manpower
31 Maintenance operations for AM include:
1  Monitoring machine usage to ensure capacity and identify demand for specific machines
2  Scheduling of machine maintenance (including cleaning, preventative parts replacements, etc.)
3  Maintenance on parts that have been made using AM to ensure durability and reliability
4  Documenting maintenance trends
5  Verifying skills levels for machine maintenance
6  Verifying environmental requirements and safety for AM machines
8  DoD Directive 8320.03, Unique Identification (UID) Standards for Supporting the DoD
9 Information Enterprise, Incorporating Change 1, November 15, 2017, is a policy for
10 development, management, and use of unique identifiers and their associated data sources to
11 preclude redundancy. A “unique identifier” is a character string assigned to a discrete entity or
12 its associated attribute that serves to uniquely distinguish it from other entities.
13  SAE AMS7002A, Process Requirements for Production of Metal Powder Feedstock for Use in
17 (2019-01-31)
20 (2021-10-28)
21  SAE AMS7022, Binder Jetting Additive Manufacturing (BJAM) Process (2020-11-19)
23 (2020-11-18)
28 build health for laser beam powder bed fusion process (Jan 2020)
29  SAE AMS7012A, Precipitation Hardenable Steel Alloy, Corrosion and Heat-Resistant Powder for
31  SAE AMS7029, Cold Metal Transfer Directed Energy Deposition (CMT-DED) Process (2020-02-03)
32  SAE AMS7034, Hybrid Laser Arc Directed Energy Deposition (HLA-DED) (2020-08-31)
33 Gap M6: Tracking Maintenance. A standard is needed for how preventative maintenance operations of
34 AM machines are tracked (e.g., monitoring printer health, need for servicing, etc.).
1 Recommendation: Develop a standard for tracking maintenance operations to ensure a printer is ready
2 when needed. See also gap PC2 on machine calibration and preventative maintenance and PC3 on
3 machine health monitoring. Develop a standard to address emergency repair/limited life parts for
4 urgent cases in the field.
6 Organization: AWS, ASTM, ISO, TAPPI

9 Repair; ☐Data


17 Current Alternative: Machine operations and maintenance manuals
18 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☒Not Started; ☒Unknown; ☐Withdrawn; ☐Closed;
19 ☐New
20 V3 Update: No general machine maintenance standard is in development. Individual standards may

21 have sections within them that recommend maintenance. Additionally, each machine will have its own
22 maintenance manual which should be followed. Lastly, ASTM AM CoE Strategic Roadmap for Research &
23 Development (April 2020) notes that AM CoE Project 1901 (WK71395) under F42.01 addresses AMSC
24 gap M6.
25 2.5.7 Additive Repair

26 Additive manufacturing can be used to rapidly repair end-use components to a ready-for-issue (RFI)
27 condition. However, many end-use structural components contain some protective coating or plating to
28 protect the component in its operational environment and extend its usable life. Component defects are
29 influenced by a multitude of conditions, including corrosion, abrasive wear, thermal stress, and cracking.
30 In order to sufficiently repair the component, coatings, and electro-plating finishes may need to be
31 stripped from the component surface and properly treated for additive manufacturing repair. The
32 preparation for an additive repair process can include removal of protective coatings and treatment of
1 the material surface. Surface preparation can include abrasive removal of coatings, such as sand
2 blasting, chemical removal, or reverse electro-plating. Additionally, the surface to be repaired via an
3 additive process needs to address surface preparation, including removal of dust, grease, oil, and
4 particulate matter. Standard processes and materials need to be identified that are compatible for use
5 with additively manufactured components, without compromising the functionality and performance
6 characteristics of the part.
7 Standards development committees active in this space include ASTM Committee B08, AWS D1.1,
8 ISO/TC 107, and SAE AMS G-8. However, no specific standards have been identified at this time.
9 Gap M8: Surface Preparation for Additive Repair. Standards are needed for chemical compatibility with
10 additively manufactured materials for surface cleaning in preparation for an additive repair process.
11 Additionally, standards are needed for removal of coatings, including paints and powder coating, and
12 plating (chrome, zinc, etc.) for additively manufactured parts.
15 Recommendation: Develop standards for approved chemical substances and mechanical processes used
16 for the removal of coatings and plating on additively manufactured components, to include metals,
17 polymers, ceramics, and other materials.
19 Organization: ASTM, SAE, ISO, AMPP, AWS D20.1

20
23 Repair; ☐Data


31 Current Alternative: Agreement between customer and organization performing repair.
2 ☐New
4 There is a lack of industry best practices on the maintenance and repair using additive manufacturing.
5 General guidance to support various sectors would be beneficial. Specific sectors will have different
6 requirements and more specific guidance. Guidance to help users understand qualification
7 considerations, especially as it relates to critical parts, and how it impacts safety, liability, and obtaining
8 performance criteria (tensile properties, hardness, wear, etc.). Additionally, moving repairs from
9 machine to machine is not always straightforward, especially in DED. Significant changes to the
10 configuration of the machine would require requalification of the repair. Considerations such as data
11 needs, powder feeding, laser spot size, speed, material flow rate (among others) should be taken in to
12 account.
14  ISO/ASTM 52931: 2023 - Additive manufacturing of metals — Environment, health and safety —
15 General principles for use of metallic materials (2023-01)
16  NEMA Policy on Reconditioned Electrical Equipment (2020-09)
17  NEMA/MITA RMD P1-2019, Considerations for Remanufacturing of Medical Imaging Devices
18 (2019-09)
19  SAE AMS7015, Titanium 6-Aluminum 4-Vanadium Powder for Additive Manufacturing (2022-04-
20 22)
21  SAE AMS7006, Nickel Alloy, Corrosion- and Heat-Resistant, Powder for Additive Manufacturing
22 52.5Ni – 19Cr – 3.0Mo – 5.1Cb (Nb) – 0.90Ti – 0.50Al – 18Fe (2022-03-21)
23  SAE AMS7020, Aluminum Alloy Powder 7.0Si – 0.55Mg – 0.12Ti (2022-11-09)
24  SAE AMS7037, Steel, Corrosion and Heat-Resistant, Powder for Additive Manufacturing, 17Cr –
25 13Ni – 2.5Mo (316L) (2021-11-23)
26  SAE AMS7018, Aluminum Alloy Powder 10.0Si – 0.35Mg (2020-05-11)
28  ISO/ASTM DIS 52938-1 Additive manufacturing of metals — Environment, health and safety —
29 Part 1: Safety requirements for PBF-LB machines
30  ISO/ASTM DIS 52933 Additive manufacturing — Environment, health and safety — Test method
31 for the hazardous substances emitted from material extrusion type 3D printers in the non-
32 industrial places
33  SAE AMS-AM Repair Committee guidance and specifications for AM repair of aerospace parts.
34 New Gap M10: Best Practices on Repair using Additive Manufacturing. Currently, there is no
35 standardized guidance on the maintenance and repair using additive manufacturing. This could be a
1 horizontal guidance applicable to all sectors detailing the best practices for manufacturers or servicers
2 performing maintenance and repair using AM.
5 Recommendation: Develop best practices on maintenance and repair using additive manufacturing
6 covering topics such as safety and reliability parameters, certification of product, and qualifications of
7 AM parts. Considerations for moving repairs from machine to machine (e.g. for DED) should be included.
9 Organization: ASTM, NEMA, ISO, SAE

12 Repair; ☐Data

18 Q&C Category: ☐Materials; ☐Processes/Procedures; ☒Machines/Equipment; ☒Parts/Devices;

20 Current Alternative: Agreement between customer and organization performing repair.
22 ☒New
23 Other Maintenance and Repair Standards Activity Since Roadmap v2 – Relevance to

26 No other related new standards Identified.
28 No other related in-development standards Identified.
1 2.6 Data
3 As a digital production process, the formatting, extraction, transfer, integration, security and
4 interoperability of data is critical along the entire additive manufacturing value chain. Data will impact
5 the design, testing, validation, qualification, and quality assurance of parts and systems in nearly all
6 industry sectors. Standards which support data management will help inform decision making in AM
7 production. The following links provide more background regarding how data and data management
8 support AM:
9  Data Driven Decision Support for Additive Manufacturing

10  A Collaborative Data Management System for Additive Manufacturing40
11
12 Standards related to data management (and other topics mentioned in the prior paragraph) are
13 currently being developed. Typically, these standards are industry agnostic but can serve as a foundation
14 from which specific sector related standards can be built on. Several of the standards referenced in this
15 chapter acknowledge the existing standardization activities either as helpful resources to support AM
16 specific standards or for adoption more broadly. The roadmap does not recommend which path but
17 leaves that to the SDOs to determine. The AM sector has begun development of AM specific data
18 standards, for example under ASTM F42.08 and in cooperation with ISO have published ISO/ASTM
19 52950:2021, Additive manufacturing -- General principles -- Overview of data processing.
20
21 As an increased focus continues to be placed on AM data specific considerations are being made for
22 laying strong foundations moving forward. For instance, a deliberate effort is being made to adopt FAIR
23 Data Principles, which stands for Findable, Accessible, Interoperable and Reusable, as they are seen as
24 important for widespread adoption of AM data sets. These principles have been adopted globally by
25 research institutions because they help increase transparency, collaboration and accelerate R&D. In
26 innovative and data reliant sectors, like AM, they can improve data management because of the volume
27 and speed of data leveraged. The FAIR concept was first defined by Scientific Data41 in March 2016. FAIR
40
Lu, Y., Witherell, P. and Donmez, M. (2017), A Collaborative Data Management System for Additive
Manufacturing, 37th Computers and Information in Engineering Conference (CIE), Cleveland, OH, [online],
https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=923075 (Accessed April 21, 2023)
41
Wilkinson, M., Dumontier, M., Aalbersberg, I. et al. The FAIR Guiding Principles for scientific data management
and stewardship. Sci Data 3, 160018 (2016). https://doi.org/10.1038/sdata.2016.18
1 principles impact on AM is discussed further in the Unleashing the Potential of Additive Manufacturing:
2 Fair Am Data Management Principles42 paper.
3 Section 2.6 Data was not developed until this version of the AMSC roadmap. All of the issues, gaps and
4 recommendations are recently identified (with the exception of DA9 and DA17 which have been
5 relocated and revised from other chapters). The structure of this section breaks down topics by data
6 related issues agnostic of sectors, AM processes or qualification and certification. Existing standards
7 development to support broader data concerns have been acknowledged (such as ISO/IEC JTC1 SC32)
8 and influenced the breakdown this section. On the other hand, the gaps within this chapters’
9 subsections (2.6.2 through 2.6.9) attempt to focus not only specifically to additive manufacturing but
10 also were considered applicable to issues that would impact various AM processes. There are data
11 related gaps in other chapters of the roadmap which focus on the specific needs of, for example, design
12 or qualification and certification.
13
14 Section 2.6.10 contains several topic areas identified by the working group members as gaps in
15 standardization. However, discussions for these areas did not mature enough to result in content
16 development. It is recommended that the AM industry discuss these further and be considered for a
17 future iteration of the AMSC roadmap.
18 Data Related Gaps in the AMSC Roadmap
19 The following gaps which appear in other chapters of the roadmap are related to data. These gaps were
20 either found in prior versions of the AMSC Roadmap or developed with a specific focus to the respective
21 chapter. The intent of this chapter is to address standardization issues that may impact several aspects
22 of the additive manufacturing sectors processes and needs. This table is provided to aid in the
23 identification of other data related standardization needs.
24
SECTION GAP NUMBER & TITLE
2.1.3 Gap DE8: Machine Input and Capability Report.
2.1.4.3 Gap DE12: Imaging Consistency
2.1.4.3 Gap DE13: Image Processing and 2D to 3D Conversion.
2.1.5 Gap DE17: Contents of a TDP.
2.1.5 Gap DE19: Organization Schema Requirement and Design Configuration Control.
2.1.5 Gap DE20: Neutral Build File Format.
2.2.2.10 Gap PC15: Configuration Management: Cybersecurity.
2.2.2.11 Gap PC16: In-Process Monitoring.
2.2.2.2 Gap PC1: Digital Format and Digital System Control.
42
Frazier, W., Lu, Y. and Witherell, P. (2021), Unleashing the Potential of Additive Manufacturing: FAIR AM Data
Management Principles, Advanced Materials & Processes magazine, [online],
https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=932826 (Accessed April 21, 2023)
2.3.3.7.2 Gap QC6: Importing Ultrasound Data.
2.3.3.7.3 Gap QC7: Protocols for Image Accuracy
2.3.3.7.13 Gap QC10: Verification of 3D Model
2.3.3.7.4 Gap QC14: Segmentation.
1
2 2.6.2 Data Formats and Representation
3 2.6.2.1 Standard Data Format for Material Characterization
4 To produce AM parts with consistent, predictable, and repeatable characteristics, materials in various
5 forms and thermal conditions need to be characterized by specific properties that support the quality
6 required by the end product. As such, material characterization data play a critical role in AM. Although
7 various standards are published by SDOs to define methods for material characterization, inspection,
8 there is no uniform way to represent material characterization results, neither any standard format to
9 represent their metadata. However, engineers, business analysts, data scientists, both OT and IT teams,
10 rely on standard formats of material characterization data and metadata to communicate, collaborate,
11 and make decisions for AM development.
14 of Data Pedigree
15  ASTM F3560-22, Standard Specification for Additive Manufacturing – Data – Common Exchange
16 Format for Particle Size Analysis by Light Scattering
18 Additive Manufacturing Processes
19  ASTM E8/E8M-22, Standard Test Methods for Tension Testing of Metallic Materials
20  ASTM E21-20, Standard Test Methods for Elevated Temperature Tension Tests of Metallic
21 Materials
22  ASTM E139-11(2018), Standard Test Methods for Conducting Creep, Creep-Rupture, and Stress-
23 Rupture Tests of Metallic Materials
24  ASTM E466-21, Standard Practice for Conducting Force Controlled Constant Amplitude Axial
25 Fatigue Tests of Metallic Materials
26  ASTM E468-18, Standard Practice for Presentation of Constant Amplitude Fatigue Test Results
27 for Metallic Materials
28  ASTM E606/E606M-21, Standard Test Method for Strain-Controlled Fatigue Testing
29  ASTM E112-13(2021), Standard Test Methods for Determining Average Grain Size
30
1 New Gap DA1: Standard Data Format for Material Characterization. There are no standard material
2 characterization data models and formats supporting the curation and exchange of AM material test,
3 inspection and characterization results and metadata.
5 R&D Expectations: R&D activities are needed to collect various material characterization reporting
6 requirements and to develop a unified data model as well as type specific models to represent AM
7 material characterization data and metadata.
8 Recommendation: Various SDOs, professional organizations, their technical committees’ members

9 should get together to harmonize the existing data reporting requirements and turn them into
10 standards data formats. Multiple standards should be developed to capture 1) (standard practice)
11 General data structure for AM material characterization; 2) Type specific standards format for AM
12 material characterization data representation.
14 Organization(s): ASTM, ISO, SAE, ASM
15 Lifecycle Area: ☐Design; ☒Precursor Materials; ☐Process Control; ☐Post-processing; ☒Finished

17 Repair; ☒Data


27 ☒New
1 2.6.2.2 Process Specific Common Data Dictionary
2 A common data dictionary allows AM data pedigree to be discovered, mapped, federated, and analyzed
3 to improve both the understanding and qualification of AM processes and parts. In 2021, ASTM
4 published a common data dictionary which captures general data elements applicable to most AM
5 process categories. They are broadly applicable to all the process categories defined in ASTM 52900
6 (2015). It is intended to be a starting point, not all-encompassing.
7 To capture, integrate or federate comprehensive data elements through AM development lifecycles

8 using various technologies, the data dictionary has to be expanded to cover process specific data
9 elements, for example, process parameters, process control, process monitoring, process validation and
10 process specific AM system descriptions.
11
13  ASTM F3490-21 Standard Practice for Additive Manufacturing — General Principles —

14 Overview of Data Pedigree [also known as the Common Data Dictionary (CDD)]
15
17 New Gap DA2 Process Specific Common Data Dictionary. There are no standard process specific
18 common data dictionary supporting the curation and exchange of data associated with a specific process
19 type, for example, data terms used specifically for PBF, DED, BJ, FDM etc.
21 R&D Expectations: R&D activities are needed to explore type-specific process data and equipment data
22 elements, which also depend on the vendors of the equipment.
23 Recommendation: Develop process specific common data dictionary standards. ASTM COE, SAE ITC
24 AMDC and America Makes etc. are creating standard data collection templates to curate data
25 contributed by their members. The standard efforts should leverage on those efforts.
27 Organization(s): ASTM F42, ISO TC 261, SAE AMS

29 Material Properties; ☒Qualification & Certification; ☐Nondestructive Evaluation; ☒Maintenance and
30 Repair; ☒Data


6 Current Alternative: Proprietary data dictionaries.
8 ☒New
9 2.6.2.3 Digital Format for In Process Monitoring Data
10 Due to various sensing technologies, vendors, and AM OEMs, there is no consistent digital format for
11 AM process monitoring to assure the interoperability of process monitoring data. There are no
12 guidelines/standards for users to leverage process data collected from different sensing
13 capacities/machine OEMs.
15  WK74390 New Practice for Additive Manufacturing of Metals -- Data -- File structure for in-
16 process monitoring of powder bed fusion
17
18 There are no known published standards.
19 New Gap DA3: Digital Format for In Process Monitoring Data. No published or in-development
20 standards have been identified for “digital format for in process monitoring” for additive manufacturing
21 technology. See also section 2.6.4.1 / gap DA12 for AM Data Collection
23 R&D Expectations: Possible development of a protocol /procedure to standardize processing monitoring

24 data format to facilitate data/knowledge sharing for process monitoring.
25 Recommendation: Develop standard protocol for “digital format for in process monitoring” and address
26 process-specific needs and/or variations in how process technologies could be monitored. The process
27 data collected from diversified sensing systems and different machines can be transformed into a
28 unified format with standardized data importing/exporting and sharing routines to facilitate broader
29 collaboration.
1 Organization(s): unknown

4 Repair; ☒Data


14 New
15 2.6.2.4 Data Capturing for Machine Logs
16 A machine log is in effect an output of the machine operations (PLCs, humidity sensors, or other parts of
17 the machine). It is important to capture this data for process control, among other applications. Due to
18 various methods additive manufacturing machine vendors use to produce machine logs, there is no
19 consistent standard for what data should be captured in them or how to deliver the information. There
20 is no concrete specification of what should be reported during the process. For some critical parts,
21 monitoring in-process variables is required - which should be put on the data format. Getting this data is
22 difficult due to the various methods machine vendors settle on. Different machine vendors use different
23 ways for capturing machine logs. Machine owners must use additional software like OSIsoft Pi
24 Connector, Montana Digital Academy (MTDA), or other machine sensor data translators. For a simple
25 log file, even a small script is needed to parse through and produce information in a useable way for
26 given investigatory needs. Logging of build interruptions is inconsistent. Lastly, there should be a
27 method to specify what events should be reported.
1
Figure 4: Example of Data Capturing for Machine Logs
2
Evolving sequence of AM NDE gaps
3 There are no known published or in development standards.
4 New Gap DA4: Data Capturing for Machine Logs During a Build. No published or in-development
5 standards have been identified for “Data Capturing of Machine Logs During A Build” for additive
6 manufacturing technology.
8 R&D Expectations: Possible development of a service to standardize machine log data outputs.
9 Recommendation: Develop standards for “Data Capturing for Machine Logs During a Build.” The
10 machine’s status can be communicated through OPC-UA, MT Connect, MQTT, RESTful API calls to local
11 databases (or equivalent) where data is being logged, reports generated from vendor software, or clear
12 text log files on the machine itself. This new standard should pick one that provides the most well-
13 rounded machine data results and provide a standard format for the output and a method to declare
14 what outputs should be generated.
16 Organization(s): ASTM, ISO
2 Material Properties; ☒Qualification & Certification; ☐Nondestructive Evaluation; ☒Maintenance and
3 Repair; ☒Data


10 ☐Personnel/Suppliers; ☒Other (specify) Additional machine sensors
11 Current Alternative: Adoption of OPC-UA, MQTT, or log file parsing on a company-by-company basis.
13 New
14 2.6.2.5 Extended Design Meta-Data Definition, Format and Management
15 The ISO/ASTM 52915:20 AMF specification includes support for 14 types of defined meta data, including
16 material, color, unit of measure, author, etc., and provides meta data fields for designer specified meta
17 data in XML v1 format. Additional design specification information can easily be added in the current
18 meta data fields. Examples include: Intellectual property attributes, cyber security attributes, source ID
19 number, author, organization, version, creation date, dimension attributes, tolerances attributes, color
20 attributes, and material attributes. Standardization of how these meta data fields are filled in will aid in
21 addressing a wide range of technical, quality, legal and security issues for AM.
23 • ISO/ASTM 52915:2020, Specification for additive manufacturing file format (AMF) Version 1.2
24 • ASTM F3490-21 Standard Practice for Additive Manufacturing — General Principles — Overview of
25 Data Pedigree (also known as the Common Data Dictionary (CDD))
26
27 There were no standards in development identified.
28 New Gap DA5: Extended Design Specifications for Meta-Data Format Standardization. There is a need
29 to standardize the type, naming conventions, and schema meta data used in design and work flow and is
30 essential to additive manufactured part and assembly quality, cyber-security and intellectual property
31 protection. This includes for example, meta data specifying unique file ID number, file source, material
1 attributes, color attributes, dimension attributes, tolerance attributes, surface characteristics, assembly
2 characteristics, intellectual property attributes, cyber-security attributes and any additional meta data
3 needed to meet quality specifications, such as layer height, print orientation, support structure
4 attributes, and embedded labeling requirements.
7 Recommendation: Standardize definitions and meta data schema for essential design, print,
8 cybersecurity and intellectual property specification information for inclusion in the ISO/ASTM 52915:20
9 standard. Utilize and expand this standard's current list of meta data definitions and schema. The
10 standard specifies meta data fields in XML v1 format for "material, color, tolerance, ID numbers, source
11 "and other attributes, but lacks schema specifications for these meta data types. The standard includes
12 a general purpose "meta data" attribute that allows for inclusion of additional types of meta data.
13 Create definitions and schema for additional meta data identified necessary to ensure quality, cyber-
14 security and intellectual property protection through the AM work flow to be listed in this "meta data"
15 attribute.
17 Organization(s): ASTM F42.08, ISO/ASTM TC261, J64, NIST
18 Lifecycle Area: ☒Design; ☐Precursor Materials; ☒Process Control; ☒Post-processing; ☐Finished

20 Repair; ☒Data

25 Extrusion; ☐Material Jetting; ☐Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photo polymerization

27 ☐Personnel/Suppliers; ☒Other (specify): Design specifications and design file, meta-data
28 Current Alternative: Ad-hoc proprietary methods
30 ☒New
1 2.6.2.6 Representation of Large Data Sets
2 Additive manufacturing is gaining an increasingly large digital presence, led by efforts such real time
3 monitoring, real time control, and NDE. Reliance on this digital presence is growing as new efforts such
4 as “born” qualified and digital twins emerge. To best leverage these data sets and maximize their utility
5 in new roles, their proverbially ad hoc existence must become more structured and formalized.
7  The HDF Group, HDF543, High-performance data management and storage suite (addresses big
8 data representation but is not AM specific)
9  ISO/IEC 11179-33:2023, Information technology — Metadata registries (MDR) — Part 33:
10 Metamodel for data set registration (part 33 replaced part 7)
11
13 New Gap DA6: Specifications and Representations for AM Big Data. There currently exists no best
14 practices or standard specifications for capturing and curating the “Big Data” in AM. Emerging uses of
15 this data, including part qualification and digital twins, will require standardized structure and best
16 practices for consistent interpretability and analysis.
18 R&D Expectations: Identifying if a single specification, set of specifications, or a guide that best meets
19 this gap. Identifying ways to meet the gap in a neutral format that can be accessed by different parties.
20 Recommendation: Develop standards which leverage the FAIR principles and ad hoc approaches,
21 engage with software vendors, practitioners, and acceptance authorities to determine best way
22 forward.
24 Organization(s): ASTM/ISO, NIST

27 Repair; ☒Data
43
Hierarchical Data Format (HDF) is a set of file formats (HDF4, HDF5) designed to store and organize large
amounts of data.

8 Current Alternative: Ad hoc
10 New
11 2.6.2.7 Additively Manufactured Electronics (AME) Data Transfer Format
12 Additively Manufactured Electronics (AME) is a new fully additive process with unique materials and
13 structures to create printed circuit boards (PCB’s). These products merge the mechanical and electrical
14 design environments by incorporating additively formed passive and semiconducting electronic and
15 mechanical components within the circuit board structure. Signal routing in a traditional PCB occurs
16 orthogonally on layers that are connected by vertical drilled and copper plated vias. AME allows the
17 interconnect to be routed in the X, Y and Z axes simultaneously using a variety of interconnect form
18 factors. Currently no SDO has a unified data format standard for AME substrates. There is an ASTM
19 mechanical data format (AMF) and an IPC Printed Circuit Board (PCB) electrical connectivity standard,
20 IPC-2581. AME substrates create traditional 3D components and interconnect structures, e.g., antennas
21 and coaxial cables, within and/or the surface of the substrate. To create a true design to manufacturing
22 high reliability automated data transfer process requires the 3D CAD information to be incorporated
23 into the 2.5D electrical CAD data.
24
26  ISO/ASTM 52915:2020 Specification for additive manufacturing file format (AMF) Version 1.2
27  IPC-2581C, Generic Requirements for Printed Board Assembly Product Manufacturing
28 Description Data and Transfer Methodology (DPMX Committee)
29
31 New Gap DA7: Additively Manufactured Electronics (AME) Data Transfer Format. AME substrates
32 create traditional 3D components and interconnect structures, e.g., antennas and coaxial cables, within
33 and/or the surface of the substrate. To create a true design to manufacturing high reliability automated
1 data transfer process requires the 3D CAD information to be incorporated into the 2.5D electrical CAD
2 data.
4 R&D Expectations: Both ECAD and MCAD software will require development to define test and then
5 implement the new data standard. Existing PCB layout software only allows trace routing on X-Y layers
6 with vias connecting the layers. AME technology allows signal routing in the X, Y, &Z axis simultaneously
7 without the use of vias. Also, 3D structures, such as coils, can be created within the structure and
8 connected to signal nets at any z-axis coordinate, such as surface mounted components.
9 Recommendation:
10 The industry needs to start the data format definition based on IPC-2581. It will take 1-2 years to define
11 the standards, another 1-2 years to fully implement and another 4+ years for industry adoption using
12 traditional new data format development cycle times. See also Section 2.3.3 and gap QC17.
14 Organization(s): ASTM, IPC

17 Repair; ☒Data


25 Current Alternative: Using multiple industry and proprietary data formats, email, and ePaper for data
26 transfer with human intervention to interpret and transcribe the data.
27 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐ Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
28 ☒New
29 2.6.3 Data Registration, Fusion and Visualization
1 2.6.3.1 Data Registration and Fusion
2 Massive complex data are generated from AM development and deployment, with a multitude of
3 modalities and high dimensions, and at various scales and sampling rates. That is, information acquired
4 from an individual data source exhibits limitations in AM decision makings. Instead, different data
5 modes offer varying amounts of discriminative information that fused not only plays a key role in
6 advancing the understanding of AM processes but also drive the engineering decision makings in the
7 lifecycle and value chain. For example, multi-modal in-process monitoring data can be co-processed for
8 better process anomaly detection and part detection prediction. For the purposes of this section, the
9 following definitions are considered:
10  Data Registration: process of transforming different sets of data into one coordinate system
11 (ISO/IEC 20005:2013)
12  Data Fusion: a multilevel, multifaceted process dealing with the automatic detection,
13 association, correlation, estimation, and combination of data and information from multiple
14 sources” [US Department of Defense, 1991]. While this definition best represents the intent,
15 there are other definitions of data fusion that could be applied.
16
17 In the NDT metrology world, data fusion based on multiple techniques provides the ability to measure
18 the same location from different viewpoints. One example of this methodology can be applying the eddy
19 current method to check surface detection, but then using ultrasonic methods to get volumetric
23 utility of the inspection results. Models include: the original part or feature model (either a surface or
24 solid model); the build model to include support structure, fixture, or base features (hybrid parts); and
25 models or data sets associated with NDE or metrology scans such as CT reconstructions and 3D and 2D
26 feature maps.
27 Data registration that aligns the orientation of these data sets in a common frame of reference is critical
28 to interpreting the differences and relationship of the features. In one example, an as-built model
29 calculated from a CT reconstruction may be compared to an original part model to determine geometric
30 fidelity, or how to orient the as-built part to find the finished product within the near net shaped
31 deposit. In another example, the comparison of the finished part model may be compared with the as-
32 deposited model and the location of near surface defects, to ensure adequate machining allowance is
33 provided to remove the defects identified within an NDE-generated data set. Thermomechanical
34 simulation may be compared with as-built data sets, to derive the character or location of distortion or
35 feature resolution from form metrology methods.
36 Relevant Publications
1  Data Registration for In-Situ Monitoring of Laser Powder Bed Fusion Processes44
2  In-Process Data Fusion for Process Monitoring and Control of Metal Additive Manufacturing45
3  Feature-Level Data Fusion for Energy Consumption Analytics in Additive Manufacturing46
4
6  ISO/IEC TR 24722:2015, Information technology — Biometrics — Multimodal and other

7 multibiometric fusion (2015-12)
8  ISO/IEC 29159-1:2010, Information technology — Biometric calibration, augmentation and
9 fusion data — Part 1: Fusion information format (2010-09)
10  ISO 23150:2021, Road vehicles — Data communication between sensors and data fusion unit for
11 automated driving functions — Logical interface (2021-05)
12  ISO/IEC 20547, Big Data Reference Architecture
13 o ISO/IEC TR 20547-1:2020, Information technology — Big data reference architecture — Part
14 1: Framework and application process (2020-08)
16 2: Use cases and derived requirements (2018-01)
17 o ISO/IEC 20547-3:2020, Information technology — Big data reference architecture — Part 3:
18 Reference architecture (2020-03)
20 Security and privacy (2020-09)
22 5: Standards roadmap (2018-02)
23  ISO/ASTM DIS 52953, Additive manufacturing for metals — General principles — Registration of
24 geometric data acquired from process-monitoring and for quality control
25  ASTM E2339-21, Standard Practice for Digital Imaging and Communication in Nondestructive
26 Evaluation (DICONDE)
27
44
Feng, S., Lu, Y. and Jones, A. (2019), Data Registration for In-Situ Monitoring of Laser Powder Bed Fusion
Processes, Proceedings of the ASME 2019 International Mechanical Engineering Congress and Exposition, Salt Lake
City, UT, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=927979 (Accessed April 21, 2023)
45
Yang, Z. , Lu, Y. , Li, S. , Li, J. , Ndiaye, Y. , Yang, H. and Krishnamurty, S. (2021), In-Process Data Fusion for Process
Monitoring And Control of Metal Additive Manufacturing, Proc. of 41st Computers and Information in Engineering
Conference (CIE), Virtual, MD, US, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=932382
(Accessed April 21, 2023)
46
Witherell, P. (2020), Feature-level Data Fusion for Energy Consumption Analytics in Additive Manufacturing,
Proc. of IEEE Conference on Automation Science and Engineering 2020, Hong Kong, HK (Accessed April 21, 2023)
1  ISO/ASTM DIS 52953, Additive manufacturing for metals — General principles — Registration of
2 geometric data acquired from process-monitoring and for quality control.
3
4 New Gap DA8: Best Practices and/or Specifications for Registering and Fusing Data Sets During the AM
5 Manufacturing and Inspection Process. There are no data registration and fusion standard supporting
6 AM data registration and data fusion for process monitoring and control, part inspection and testing,
7 and AM qualification and certification.
9 R&D Expectations: R&D activities are needed to explore the equality of multi-modality data fusion for
10 part qualification compared to the traditional test intensive qualification methods.
11 Recommendation: The following are needed to address the gap:
12  Specific industry standards for data registration and fusion for integrative AM data analysis
13  Expert education, training, and certification for AM data fusion for process control, NDT and
14 qualification.
15
16 Collaborative efforts should be made by government agencies, academia and industry to develop new
17 data registration and fusion methods to support process control, NDE data fusion for post process part
18 inspection and qualification, and material and process development based on both simulation and
19 measurement data from various material and processes.
21 Organization(s): IEC, ISO, ASTM
22 Lifecycle Area: ☒Design; ☐Precursor Materials; ☒Process Control; ☒Post-processing; ☒Finished

24 Repair; ☒Data

28 Process Category: ☒All/Process Agnostic; ☒Binder Jetting; ☒Directed Energy Deposition; ☒Material
29 Extrusion; ☒Material Jetting; ☒Powder Bed Fusion; ☒Sheet Lamination; ☒Vat Photopolymerization

1 Current Alternative: Proprietary solutions.
3 ☒New
4 Data fusion in the NDT metrology world is defined as applying more than one NDT technique to provide
5 additional, complementary, or redundant information that can conform with the result. Data fusion
6 provides the ability to measure the same location from different viewpoints. This is needed because of
7 the complex geometry that might exist in AM parts. Setting this process up is not easy as it might require
8 a robotic-based or automated positioning system. One example of this methodology can be applying the
9 eddy current method to check surface detection, but then using ultrasonic methods to get volumetric
13 utility of the inspection results. NDE data plays an important role in product acceptance/rejection,
14 validation of simulation/predictive models, process improvement, and potentially process control.
15 Models include: the original part or feature model (either a surface or solid model); the build model to
16 include support structure, fixture, or base features (hybrid parts); and models or data sets associated
17 with NDE or metrology scans such as CT reconstructions and 3D and 2D feature maps. The orientation of
18 these data sets in a common frame of reference is critical to interpreting the differences and
19 relationship of the features. In one example, an as-built model calculated from a CT reconstruction may
20 be compared to an original part model to determine geometric fidelity, or how to orient the as-built part
21 to find the finished product within the near net shaped deposit. In another example, the comparison of
22 the finished part model may be compared with the as-deposited model and the location of near surface
23 defects, to ensure adequate machining allowance is provided to remove the defects identified within an
24 NDE-generated data set. Thermomechanical simulation may be compared with as-built data sets, to
25 derive the character or location of distortion or feature resolution from form metrology methods.
27  ASTM WK73978 New Specification for Additive Manufacturing-General Principles-Registration of

28 Process-Monitoring and Quality-Control Data (F42.08)
29
30 No published standards have been identified.
31 Gap DA9 (formerly NDE5 in V2): Data Fusion. Since multiple sources and results are combined in data
32 fusion, there is a possible issue of a non-linear data combination that can produce results that can be
33 influenced by the user. Additionally, data fusion may employ statistical techniques that can also
34 introduce some ambiguity in the results. While likely more accurate than non-data fusion techniques,
35 introduction of multiple variables can be problematic. Data fusion techniques also require a certain level
36 of expertise by the user and therefore there might be a need for user certification. The demand is not
1 NDE specific, but instead more for fusing NDE data with in-process data to correlate to determine
2 effectiveness of methods or to create more of a digital record of the part. Some considerations are:
3 - What data is recommended to be exported out of these standards?

4 - What data processing and visualization come into play?
5 - What are the expected/necessary data outputs, CT, and/or other methods?
6 - What are the needs for real time vs not real time data fusion. These demands would be very different
7 (alignment and processing of data) than going offline. Process data with fusion does relate to other real
8 time needs. What are the cross correlations?
10 R&D Expectations: N/A, information theory sciences are well established.
12  Specific industry standards for data fusion in AM NDT techniques

13  Expert education, training, and certification for AM data fusion in NDT
14
17 Lifecycle Area: ☐Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; Finished Material
18 Properties; ☐Qualification & Certification; ☒Nondestructive Evaluation; ☐Maintenance and Repair;
19 ☒Data


29 ☐New
1 2.6.3.2 Anomaly Detection, Localization and Prediction
2 AM processes are inherently highly unstable. Therefore, even using the same process parameters and
3 part design, the AM fabricated parts may demonstrate different quality. Given the high process
4 uncertainty in AM processes, it is of utmost importance to perform timely anomaly detection,
5 localization, and part defect prediction. By leveraging the real-time sensing systems, the process data
6 can be collected and machine learning models (e.g., artificial neural networks and convolutional neural
7 networks) can be trained for real-time anomaly detection, localization, and prediction. For supervised
8 learning, labels are obtained from post-manufacturing characterization. However, the response labeling
9 causes a critical issue, since there is no standard to set up the threshold to distinguish between healthy
10 and anomaly in the post-manufacturing characterization. Furthermore, even though there are a lot of
11 research efforts focused on anomaly detection for different AM processes, each research study focuses
12 on one AM process using a specific sensing system/technology, there is no standard available for best
13 practices for the evaluation of data set used for part defect prediction purpose.
16 for Laser Powder Bed Fusion
17  ISO/ASTM52904-2019, Additive Manufacturing – Process Characteristics and Performance -
18 Practice for Metal Powder Bed Fusion Process to Meet Critical Applications
19
20 No in-development standards were identified.
21 New Gap DA10: Best Practices for Anomaly Characterization and Localization for Part Defect
22 Prediction Purpose. There are no standard AM process anomaly detection methods for part defect
23 prediction for different AM processes.
26 Recommendation: Various technical committees should get together to consolidate a list of existing
27 anomaly detection and location methods, categorized by different sensing capacity and different AM
28 processes. Since different AM processes may present completely different anomaly, defect, and
29 corresponding failure modes, multiple standards should be developed to summarize: 1) standard
30 practice for sensing capability requirement determination for AM process anomaly detection; 2)
31 standard operation procedure for anomaly detection method assessment in different AM processes; 3)
32 labeling strategy for both qualitative (e.g., microstructure characterization) and quantitative (e.g., X-ray
33 CT inspection for porosity size, morphology, and distribution) post-manufacturing characterizations.
1 Organization(s): ASTM, ISO, SAE

4 Repair; ☒Data


12 Current Alternative: Data analytics is handled on a case by case basis.
14 New
15 2.6.3.3 Digital Twin Development and Application
16 While AM data continues to provide insight into AM processes, it is being increasingly used to provide
17 insight into AM parts. From design to inspection, the fabrication of an AM part is leaving an increasingly
18 large digital footprint. However, this large amount of data is not often deliberately packaged in a way
19 that in can be interpreted and analyzed to support part evaluation and acceptance. Subsequently large
20 data sets associated with AM parts are not easily interpreted and are subject to various unknown
21 assumptions, idealizations, and simplifications that ultimately restrict the utility of the data in facilitating
22 part acceptance.
23 See also, NIST report on Digital Twin-Based Cyber-Attack Detection Framework for Cyber-Physical
24 Manufacturing Systems
26  ISO 23704-3:2023, General requirements for cyber-physically controlled smart machine tool
27 systems (CPSMT) — Part 3: Reference architecture of CPSMT for additive manufacturing
28
30  ISO/ASTM PWI 52951, Data Packages for AM
1
2 New Gap DA11: Need for Consistent Part Traceability and Provenance (Digital Twin). New methods are
3 needed to define and guide how AM data can be associated with different phases of an AM part
4 fabrication so that this data can be readily and consistently interpreted to establish traceability and part
5 provenance. An established approach to the development of an AM digital twin will help address this
6 need.
8 R&D Expectations: R&D to establish the guidance/meta model for development of an AM digital twin
9 that explicitly establishes traceability and provenance of an AM part.
10 Recommendation: New efforts needed to focus on standard development that relates qualification gaps
11 to data representations, including addressing formats, data structure, and digital thread. Standards
12 which augment the connection between engineering intent and manufacturing systems (i.e. neutral file
13 format, STEP, XML, HDF5, AMF, or others) and enable digital twin are needed.
15 Organization(s): ASTM, ISO, NIST

18 Repair; ☒Data


26 Current Alternative: Ad hoc.
28 ☒New
29 2.6.4 Data Management
1 2.6.4.1 AM Data Collection
2 Currently AM machine OEM’s create data with varying file naming standards, data content types, and
3 timestamp formats. This leads to the need to support multiple data standards increasing the cost of
4 leveraging data sets.
6  F3560-22 Common Data Exchange Format for Particle Size provides a standardized JSON
7 structure for reporting powder stock testing data.
8
10 New Gap DA12: Best Practices and Guidance for AM Data Collection. Data from AM machines varies in
11 its format, level of detail, and interoperability. A standard set of data formatting and available data
12 types needs to be developed.
14 R&D Expectations: Collect A wider array of machine data examples should be gathered to provide
15 further examples of the disparity and data available across various implementations.
16 Recommendation: Create a data standard that addresses at a minimum the expected minimum data
17 availability from a machine, a variable and file naming structure for the data, and ensures
18 interoperability on timestamp formats, data encoding, and packaging pertinent meta-data about the
19 machine and the build. The goal should be to have a methodology that ensures that if, for example, two
20 LPBF machines are being used and you receive similar data, that you can leverage that data in a
21 common way. Ensure that the developed guidance works to use existing data standards where
22 applicable, the format of the data is supported by common industry tools (similar to F3560-22’s use of
23 JSON), and that there is guidance on how to test methods and equipment that provide the data.
25 Organization(s): ASTM, All applicable SDOs

28 Repair; ☒Data


7 New
8 2.6.4.2 Data Aggregation
9 Both time-series and file object data related to additively manufactured parts, coming from various
10 equipment, lack a standard method of aggregation (or grouping it together for one view of the data).
11 Some companies aggregate by the machine’s Build Job ID. However, some data (e.g. powder testing
12 data) is created before the print process; so, another ID must be used to track and aggregate this data as
13 well. The pre-print, print, and post-print data generators need a standard method to properly aggregate.
14 The same method devised for aggregation is required for fusion, or the combining of data from multiple
15 sources to achieve inferences that cannot be obtained from a single source, a similar method is needed
16 to bring this data together.
17 No published or in development standards have been identified.
18 New Gap DA13: Data Aggregation of Time Series and Object Data. No published or in-development
19 standards have been identified for “Aggregation / Data Fusion of time series and object data” for
20 additive manufacturing technology.
23 Recommendation: Develop guidance on the aggregation of time series and object data. Identifiers can
24 be obtained from most 3D Printer devices as a result of a job instantiation. Identifiers can also be
25 obtained from a chosen manufacturing execution system (MES) in relation the jobs to be performed.
26 However, choosing which, both, or another separate identifier is a matter of the solution identified to
27 properly close this gap.
29 Organization(s): ASTM, ISO
1 Lifecycle Area: ☐Design; ☒Precursor Materials; ☒Process Control; ☒Post-processing; ☒Finished
3 Repair; ☒Data


10 ☒Personnel/Suppliers; ☒Other (specify) Additional machine sensors
11 Current Alternative: Individual application development or manual data aggregation/fusion
13 New
14 2.6.4.3 Data Retention
15 Striking a balance amongst retaining data for immediate analysis, quality control, product qualification,
16 and long-term regulatory requirements is difficult amidst the rising quantity of data and costs of data
17 storage. Companies struggle to declare a one-size-fits-all approach to data retention due to these
18 varying factors. Often, in aerospace for example, there are at least three factors for retention based on
19 business unit, data owner, and regulatory bodies. Without a standard approach to rendering data down
20 to just what is absolutely needed and providing a technological way to re-inflate the data for deeper
21 analysis if needed later than the retention period, the persistent issue of data bloating is inevitable.
22 Additionally, cloud technology providers continue to compete, providing various new technologies and
23 cost differentiations with multiple tiers of storage. These complexities make it difficult for businesses to
24 make quick and effective decisions for their data and costs.
25 No published or in development standards have been identified.
26 New Gap DA14: Data Retention Guidelines. No published or in-development standards have been
27 identified for “Data Retention Guidelines” for additive manufacturing and related technologies.
29 R&D Expectations: Possible development of algorithms for data size reduction with minimal data loss
30 (e.g. akin to the .jpeg format being a lossy format but still high quality enough for the naked eye).
1 Recommendation: Develop standards for “Data Retention Guidelines.” New algorithms or
2 recommendations for proper use of existing algorithms that target AM data (e.g. melt pool h5 data,
3 optical tomography .raw or .tiff imagery). A standard cloud provider agrees to data reduction and lowest
4 cost storage tiers. Also, recommendations to industries for duration data should be retained based on
5 analysis and regulatory needs.
7 Organization(s): ASTM, ISO, applicable regulatory and certifying bodies
8 Lifecycle Area: ☐Design; ☒Precursor Materials; ☐Process Control; ☒Post-processing; ☒Finished

10 Repair; ☒Data

16 Q&C Category: ☒Materials; ☐Processes/Procedures; ☒Machines/Equipment; ☒Parts/Devices;

17 ☐Personnel/Suppliers; ☒Other (specify) Additional machine sensors & imagery
18 Current Alternative: Complex architectures and agreements both with internal organizations and
19 external cloud providers. Data simply retained for as long as possible because a standard is not declared.
21 ☒New
22 2.6.5 Data Quality

23 Data quality has been defined in ISO/IEC 8000 - Data Quality as “degree to which a set of inherent
24 characteristics of data fulfils requirements” which is not specific to AM. Examples of data characteristics
25 include accuracy, completeness, confidence, consistency, timeliness and usability. Data quality is vital
26 for additive manufacturing because data are increasingly used to drive AM development and operations
27 and directly impacts the reliability of the manufacturing processes and effectiveness of the decision-
28 makings.
29 While there are several standards and guidelines that address aspects of data quality and management
30 in the context of manufacturing and related industries, measurement and specifications on AM data
1 quality are needed for process control, process optimization, preventive maintenance, supply chain
2 management, part qualification and certification, and regulatory compliance.
3 The electronics sector looks at data quality from two perspectives; one from data structure and accuracy
4 and the second if it matches the manufacturing capability and design intent. In the circuit board
5 industry, less than 5% of the manufacturing requires editing.
7  ISO 9001:2015, Quality Management Systems – Requirements (reconfirmed in 2021)

8  ISO 19157:2013, Geographic information — Data quality
9  ISO 22400-1:2014, Automation systems and integration — Key performance indicators (KPIs) for
10 manufacturing operations management — Part 1: Overview, concepts and terminology
11 (reconfirmed in 2022)
12  ISO 22400-2:2014, Automation systems and integration — Key performance indicators (KPIs) for
13 manufacturing operations management — Part 2: Definitions and descriptions (2014-01)
14  ISO/IEC 8000, Data Quality: This series of standards focuses on data quality management and
15 provides a general framework for managing data quality across different industries and
16 applications, including manufacturing.
17  ISO/IEC 27001:2022, Information security, cybersecurity and privacy protection — Information
18 security management systems — Requirements (2022-10), which establishes requirements for
19 information security management systems (ISMS) to protect the confidentiality, integrity, and
20 availability of information, which can be critical for maintaining data quality in manufacturing
21 systems.
22  SAE AS9100D, Quality Management Systems - Requirements for Aviation, Space, and Defense
23 Organizations (2016-09-20)
24
26
27 New Gap DA15: Assessment and Specifications of AM Data Quality. There are no standard metrics to
28 measure AM data quality and the impact on AM decision making; There is no standard specification on
29 AM data quality for data driven AM qualification and certification.
31 R&D Expectations: Efforts should be made to review the existing data quality standards and identify the
32 needs of AM data quality management and develop guidelines for AM data quality control.
33 Recommendation: Develop standards which define aspects of data quality specific to AM. NIST to assist
34 with a review on existing data quality standards and their applicability to AM, as well as the gaps to
35 enable data driven AM decision makings.
1 Organization(s): ASTM, ISA, ISO, NIST, SAE

4 Repair; ☒Data


12 Current Alternative: None specific for AM but sector agnostic standards listed above may be used.
14 ☒New
15 2.6.6 AM Value Chain Data Usage and Management

16 2.6.6.1 Digital Thread
17 AM process chains and value chains are inherently disparate, with organizations, processes, machines,
18 and software all contributing to variations in the AM “digital thread.” With the maturation of AM
19 processes technologies, AM part fabrication is increasingly being integrated into supply chains.
20 Additionally, AM data is being increasingly relied upon to establish AM part quality. Instances such as
21 these require a consistent understanding of the AM fabrication process, especially when that process is
22 organizationally and geographically distributed.
24  ISO 23704-3:2023, General requirements for cyber-physically controlled smart machine tool
25 systems (CPSMT) — Part 3: Reference architecture of CPSMT for additive manufacturing
26 (defines digital thread but is not commonly adopted by the AM sector)
27
29  ISO/ASTM PWI 52951, Data Packages for AM

30
1 New Gap DA16: Reference Workflow (Digital thread) for AM Part Fabrication. With AM workflows
2 becoming increasingly important, for instance in establishing part provenance or integrating supply
3 chains, new standardized references are needed. A standardized AM workflow, or digital thread, is
4 needed to provide a consistent refence for the various processes and activities associated with AM part
5 fabrication.
7 R&D Expectations: R&D to establish what level of detail for a reference makes sense, and the role of
8 data representation/formats when referencing the workflow.
9 Recommendation: Continue to develop ISO/ASTM PWI 52951 and then create additional guidance as
10 needed.
12 Organization(s): ASTM, ISO, NIST

15 Repair; ☒Data


23 Current Alternative: Ad hoc.
25 ☒New
26 2.6.7 AM Data Security & IP Protection

27 2.6.7.1 AM Security Guidelines
28 Manufacturers need AM security guidance. Factors contribute to this need:
1 1. Increasing industry adoption of AM technology
2 2. A large body of research demonstrating the ability of attackers to manipulate AM 3D geometry
3 and process data and achieve adverse impacts to manufacturers and their customers
4 3. Layer-based technology introduces more attack vectors than non-layered manufacturing
5 technologies, but also may provide more opportunities to detect or respond to an attack
6 4. Diversity of material types and processing technologies implies need for process technology-
7 specific guidance, although there is some general guidance that applies across AM technologies
8
10  ISO/IEC 27001:2022, Information security, cybersecurity and privacy protection — Information

11 security management systems — Requirements (2022-10)
12  NIST Cybersecurity Framework 1.1
13  NIST Cybersecurity Framework Version 1.1 Manufacturing Profile, NISTIR 8183 Rev. 1
14
17 AM Security (F42.08)
18  NIST Cybersecurity Framework 2.0
19  NIST Special Publication 800-82 Rev. 3, Guide to Operational Technology (OT) Security (Initial
20 Public Draft)
21
22 New Gap DA17: AM-Specific Security Guidance. Although numerous groups have standardized IT
23 cybersecurity and privacy guidance, and a growing number of standards address OT security, no
24 standardized guidance specifically addresses AM security.
26 R&D Expectations: More research needed on security for non-extrusion AM processes. More research
27 needed on applying content management technologies to security guidance publications to better
28 manage dependencies of process-specific guidance on general AM security guidance, AM security
29 guidance on OT security guidance, etc.
30 Recommendation: Complete work on ASTM F42.08 WG WK78322, whose guidance should not be AM
31 process-specific. Subsequent guidance standards should address specific process technologies.
33 Organization(s): ASTM, America Makes, NIST
3 Repair; ☒Data


13 New
14 2.6.7.2 Cybersecurity
15 Issues related to cybersecurity (digital thread) for AM technology and maintenance relate to both AM
16 parts and AM machines. Examples of related concerns include: intentional corruption of drawing files;
17 intentional corruption of tool files; hacking and theft of designs; industrial espionage; counterfeiting and
18 anti-counterfeiting; theft of intellectual property rights including patents, trade, service, and
19 certification marks; copyright; and unqualified (low quality) parts being fielded on viable systems risking
20 degradation of performance, reliability, and potential safety issues.
21 Cybersecurity for AM maintenance relates to the users themselves, networks, devices, software,
22 processes, information in storage or transit, applications, services, and systems that can be connected
23 directly or indirectly to networks.
25  NIST Special Publication 800-37, Revision 2, Risk Management Framework for Information
26 Systems and Organizations - A System Life Cycle Approach for Security and Privacy.
27  NIST Special Publication 800-53, Revision 5, Security and Privacy Controls for Information Systems
28 and Organizations.
29  NIST Special Publication 800-82, Revision 3:(Draft), Guide to Operational Technology (OT)
30 Security.
31  NISTIR 8023, Risk Management for Replication Devices.
1  NISTIR 8041, Proceedings of the Cybersecurity for Direct Digital Manufacturing (DDM)
2 Symposium (April 2015)
3  NISTIR 8183, Cybersecurity Framework Manufacturing Profile47
4  National Defense Industrial Association (NDIA) Cybersecurity for Advanced Manufacturing White
5 Paper (May 2014), which includes a short note that “While additive manufacturing is inherently
6 no more vulnerable than other manufacturing methods, the opportunity exists to build more
7 security into these emerging systems now”
8  NEMA White Paper, Supply Chain Best Practices
9  NEMA/MITA White Paper, Cybersecurity for Medical Imaging
10  PWG 5199.10-2019: IPP Authentication Methods v1.0
12  ASTM WK76970: Guidelines for Technical and Intellectual Property Authentication and
13 Protection
14  ASTM WK78322, New Guide for Additive Manufacturing -- General Principles -- Guidelines for AM
15 Security.
16
17 Other notable activities include:
18  Defense Federal Acquisition Regulation Supplement (DFARS) Publication Notice 20160802,

19 Detection and Avoidance of Counterfeit Electronic Parts – Further Implementation (DFARS Case
20 2014-D005).
21  The National Defense Industrial Association (NDIA) Cybersecurity for Advanced Manufacturing
22 (CFAM) Joint Working Group (JWG). CFAM was launched in November 2015 as a government
23 and industry collaboration to identify cybersecurity threats, vulnerabilities, and consequences in
24 defense contractors' manufacturing networks and to define actions to mitigate those risks. The
25 group held its first public forum on August 18, 2016, to raise awareness to the manufacturing
26 networks' cyber threats facing the defense industrial base and to introduce the CFAM JWG to a
27 broader community. A second public forum was held on November 15, 2016 where JWG team
28 leaders presented their findings and recommendations to improve cybersecurity in the defense
29 industrial base's manufacturing networks.
30  National Electrical Manufacturers Association (NEMA) anti-counterfeiting initiative
31  International AntiCounterfeiting Coalition (IACC), which encompasses 250+ member companies
32 in 40+ countries from various industries
33 Gap DA18 (formerly M7 in V2): Additive Manufacturing Supply Chain Security: Guidance is needed that
34 addresses cyber and non-cyber threat (i.e. side channel attacks) security considerations for ordering,
47
The landing page for NIST’s research and standards activity for cybersecurity for general IT can be found at:
https://www.nist.gov/topics/cybersecurity.
1 maintenance, repair and replacement parts that have 3D models ready to print to ensure that a build
2 has not been sabotaged and that IP has not been stolen. Secure storage should ensure that only
3 authorized personnel can access files and print parts. Maintenance security guidance for AM machines
4 should be similar to that of other industrial machines. However, AM machines could be used in
5 environments where maintenance may not be executed with the same degree of rigor or with the same
6 quality control checks as in conventional settings. For example, a military organization could use a 3D
7 printer at a battle location to print replacement parts. AM security guidance could perhaps suggest
8 compensating controls in such scenarios where the usual controls are infeasible.
11 Recommendation: Guidance is needed to ensure the confidentiality, integrity, and availability of AM

12 data as procurement, maintenance and repair operations may take place in an uncontrolled
13 environment. See also gap PC15 Configuration management: cybersecurity.
15 Organization: NIST, NEMA/MITA, NDIA JWG, ASTM, IEEE-ISTO PWG

18 Repair; ☒Data

21 Material Type: ☒All/Material Agnostic; ☐Metal; ☐Polymer; ☐Ceramic; ☒Composite
24 Q&C Category: ☐Materials; ☒Processes/Procedures; ☒Machines/Equipment; ☒Parts/Devices;

28 ☐New
29 V3 Update: See full list of documents above. Since Roadmap v2.0, PWG 5199.10 was published. New
30 ASTM WK78322 will establish AM Security practices necessary to protect additive manufacturing parts
31 structural integrity, provenance throughout production chain, and protection of technical data. The
32 standard will identify and categorize security threats in AM, highlight characteristic aspects of AM
1 security that require special considerations, and describe the mitigations the manufacturing life cycle.
2 This gap in AMSC Roadmap v2 was originally “cybersecurity for maintenance” however the issue was
3 broader than maintenance, and instead across the supply chain and AM process. Updates have been
4 made for v3 to better reflect the intent and need for standards.
5 2.6.7.3 Technical and IP Authentication and Protection
6 The primary issue is the lack of standards on how to record, display, transmit and retain the intellectual
7 property rights for AM design files and derivative works created during the design to print to post
8 process work flow. For example, copyrights, patents, and authorized use notices; access privileges, etc.
9 The secondary issue has to do with how to protect the IP records, displays and archives of such files. A
10 tertiary issue relates to other methods of authentication, including methods designed into the file,
11 mechanical or chemical operations to the printed part, or post processing methods of authenticating the
12 printed part.
15 Technical and Intellectual Property Authentication and Protection (F42.08)
16
17 No published standards have been identified.
18 New Gap DA19: Technical and IP authentication and protection. This gap is distinct from cybersecurity
19 issues. There is currently no standardized method of labeling, securing and authenticating the
20 intellectual property ownership and related rights to AM designs, files and metadata. This creates an
21 opportunity for unauthorized use and/or counterfeiting of AM printed objects. There is no standardized
22 method of authenticating printed parts for counterfeiting.
25 Recommendation: Complete and publish WK76970. Revise ISO/ASTM 52915 to include support for
26 technical guidance and meta data specifications in WK76970.
28 Organization(s): ASTM F42.08, ISO/ASTM TC261, J64, NIST
29 Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☒Post-processing; ☐ Finished

31 Repair; ☒Data
2 ☐Energy; Medical; ☐Spaceflight; ☐Other (specify) ______________________
5 Extrusion; ☐Material Jetting; ☐Powder Bed Fusion; ☐Sheet Lamination; ☐Vat Photo polymerization

7 ☐Personnel/Suppliers; ☒Other (specify): Source file data, meta-data
8 Current Alternative: Ad hoc proprietary methods
10 ☒ New
11 2.6.8 Data Architecture Integration and Interoperability

12 2.6.8.1 AM System Integration and Data Integration Architecture
13 AM technology is transitioning from prototyping to industrialization, however, with a limited scale. One
14 of the more pressing problems is the lack of system and data integration. The AM systems are
15 commonly siloed, and existing manufacturing executive systems are seldom set up for AM-based
16 production. Hence real-time production monitoring and manufacturing intelligence cannot be
17 established. The big data generated from AM in-process monitoring and nondestructive evaluation are
18 commonly acquired manually and scattered around the shop floor. The AM engineering data are still
19 seldom reused across departments. Challenges in AM data integration stem from the complexity of the
20 tasks, including: the wide scope of integration across product, machine, and material domains, where
21 communication methods and protocols diverge, the high variety of data types, the unstructured high
22 volume and high velocity nature of the data.
23 For the purposes of this section, data integration is defined as the process of combining data residing in
24 different sources and providing users with a unified view of them, ISO/IEC 30145-3:2020(en), 3.1.7
26  ISA 95, Enterprise-Control System Integration (addresses traditional manufacturing system and
27 data integration but leaves gaps for AM)
28  ISA 88, Batch Control (for batch manufacturing)
29  OPC 40540, The Future OPC UA Interface for Additive Manufacturing (UA4AM) is intended to
30 facilitate the exchange of information between an AM machine and software systems such as
31 MES, SCADA, ERP or data analysis systems
1  IEC PAS 63088:2017 Smart manufacturing - Reference architecture model industry 4.0 (RAMI4.0)
2  ISO/IEC 20547, Big Data Reference Architecture
4 1: Framework and application process (2020-08)
6 2: Use cases and derived requirements (2018-01)
8 Reference architecture (2020-03)
10 Security and privacy (2020-09)
12 5: Standards roadmap (2018-02)
13
15  IEC/CD TR 63319, A meta-modelling analysis approach to smart manufacturing reference models

16
17 New Gap DA20: AM Machine Data Framework and Guideline for Automated AM Data Integration and
18 Management. Even though both AM machine builders and industrial automation software providers are
19 creating partnerships to push the development of AM integration and data management solutions, the
20 applications are not reported, and standard practices have not been established and shared on how AM
21 machines can be easily integrated with existing manufacturing systems for industrialization, including
22 supervisory control and data acquisition (SCADA), MES, product lifecycle management (PLM) and
23 enterprise resource planning (ERP) systems. In addition, there are no communication specifications
24 defined to integrate and stream high-speed and high volume in-process data.
28  Standardized AM machine data framework to support AM in-process data integration for real-time
29 manufacturing operations
30  Specifications for communication protocols for high-speed AM in-process big data streaming and
31 analysis
32  Extended existing system and data integration architecture, for example, ISA 95, for AM data and
33 system integration for industrialization
34  Guidelines, best practices and tools for AM data integration and management, including research
35 data, engineering data, production data, inspection data and testing data.
36
1 Organization(s): IEC, ISO, ASTM, OPC, UMATI
2 Lifecycle Area: ☒Design; ☐Precursor Materials; ☒Process Control; ☒Post-processing; ☒Finished

4 Repair; ☒Data


12 Current Alternative: Proprietary solutions.
14 ☒New
15 2.6.9 Sector Related Needs

16 2.6.9.1 Medical AM Design File Retention
17 There is no standard for retention of medical AM design files used to produce an AM medical device.
18 Retention of such files are required to meet HIPAA and FDA regulatory requirements.
19
21  DICOM, Digital Imaging and Communication in Medicine

23
25 New Gap DA21: Medical AM design file retention. Standards are needed on how to store, label and
26 provide access to medical AM design files derived from radiologic scans.
1 Recommendation: Draft standard guidance for storing, labeling and publishing medical AM design files
2 to meet HIPAA and FDA regulatory requirements.
3 Priority: High; ☒Medium; ☐Low
4 Organization(s): ISO/ASTM TC261, DICOM

7 Repair; ☒Data


14 ☐Personnel/Suppliers; ☒Other (specify) Design File Data
15 Current Alternative: The information is discarded except the design file (STL, OBJ or other format)
16 information addressed by DICOM. DICOM specification for storing an encapsulated .STL file (not
17 adequate to meet HIPAA and FDA requirements).
18 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; ☐ Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
19 ☒New
20 2.6.9.2 Medical AM Quality Management Systems
21 The FDA is proposing to expand regulation of hospitals and other "point of care" medical facilities
22 conducting additive manufacturing of medical devices to include individual, patient specific medical
23 devices. This will require point of care facilities to comply with FDA guidance governing manufactured
24 medical devices. A critical requirement within this regulatory "framework" is the creation and use of a
25 quality management system (QMS) that will facilitate validation of each medical device's quality by the
26 producer of the device. The FDA has the authority to contract with accredited third-party organizations
27 to audit and verify quality of medical devices produced by a POC facility.
28 A large percentage of medical devices produced using AM are derived from radiologic scans. Selected
29 scan sets are edited and altered by segmentation software and saved in formats that can be input to
30 CAD or other modeling software to design the medical device. The segmenting, editing, conversion and
1 repairing of these files results in some degradation of the design files, thereby impacting accuracy,
2 precision and overall quality of the medical device produced.
3 At the present time there is no standard for how to record, transmit and maintain the digital source files
4 quality attributes and their modifications created by segmentation, file repair and 3D modeling
5 applications (that affect resolution, accuracy, and dimensional tolerances) through this work flow. This
6 creates a barrier to validation and verification of a medical device produced using AM technology.
7 Relevant Publications
8  U.S. FDA published "Discussion Paper: 3D Printing Medical Devices at Point of

9 Care"(December 2021)
10  Radiological society of North America (RSNA) 3D Printing Special Interest Group (SIG):
11 Guidelines for medical 3D printing and appropriateness for clinical scenarios (November
12 2018)
13  21 CFR Chapter 1, Subpart H, Medical Devices
14

17 image data
18  ISO/ASTM 52915:2020, Specification for additive manufacturing file format (AMF) Version
19 1.2
20
22 New Gap DA22: Quality Management of Medical AM Files. There is no comprehensive standard
23 method for recording, transmitting and maintaining AM quality related meta data from radiologic scan
24 to final part. This information is needed to comply with FDA quality validation and verification
25 requirements for AM medical device manufacturing.
28 Recommendation: Revise ISO/ASTM 52915 and ISO/ASTM 52916 to address this gap. Draft revisions to
29 augment specified standards to provide guidance on how to implement a method to record, transmit
30 and maintain design file quality related meta data from radiologic scan to final part; including but not
31 limited to: file resolution, accuracy, dimensional tolerances, surface characteristics, and any additional
32 FDA specified meta data, such as device labeling, as well as work-in-process file retention to retain any
33 revisions to such meta data. Standardization of meta data terminology will facilitate programmatic
34 transmission of meta data through the entire work flow.
2 Organization(s): ISO/ASTM TC261, RSNA, NIH, American College of Radiology (funding)
3 Lifecycle Area: ☒Design; ☐Precursor Materials; ☒Process Control; ☐Post-processing; ☒Finished

5 Repair; ☒Data

7 ☐Energy; ☒ Medical; ☐Spaceflight; ☐Other (specify) ______________________

12 ☐Personnel/Suppliers; ☒Other (specify) Source file data quality
13 Current Alternative: Ad hoc proprietary methods
14 V3 Status of Progress: ☐Green; ☐Yellow; ☐Red; Not Started; ☐Unknown; ☐Withdrawn; ☐Closed;
15 ☒New
16 2.6.10 Data Gaps for Future Consideration

17 This contains several topic areas identified by the working group members as gaps in standardization.
18 However, discussions for these areas did not mature enough to result in content development. It is
19 recommended that the AM industry discuss these further and be considered for a future iteration of the
20 AMSC roadmap. The additional standardization areas are listed under the originally proposed Section
21 2.6 subsection they were identified against.
23 considerations and standards and R&D needs for the following topic areas.
2.6.2 Data Formats and Representation

Customizable data acquisition template
Evaluating data maturity for usage and adoption
2.6.3 Data Registration, Fusion and Visualization
Digital twin (virtual machine) framework for testing models in simulation
2.6.4 Data Management
Exchange and reuse of AM data
Feedback of data
2.6.6 AM Value Chain Data Usage and Management
Scenario-specific data selection
Capability of machine data sheets
2.6.7 AM Data Security & IP Protection
Cybersecurity framework profile / meta data provisions specifications
2.6.8 Data Architecture Integration and Interoperability
Guidance to integrate varying data sources
Guidance on high-volume and high-speed data integration
AM Data for Models and Machine Learning
Guidance for establishing correlation models
Data Through Part Development Lifecycle
Evaluation of data quality
Using in-process data
Product and coupon handling and management
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2 3. Next Steps
3
4 This roadmap should be widely promoted among interested stakeholders so that its recommendations
5 see broad adoption.
6 To the extent R&D needs have been identified, the roadmap can be used as a tool to direct funding to
7 areas of research needed in additive manufacturing.
8 In terms of standards activities, an ongoing dialogue among affected stakeholders would be beneficial to
9 continue discussions around coordination, forward planning, and implementation of the roadmap’s
10 recommendations. Such a dialogue can also identify emerging issues that require further elaboration.
11 It is recognized that standardization activity will need to adapt as the ecosystem for additive
12 manufacturing evolves due to technological innovations and as additional industry sectors enter the
13 additive manufacturing market.
14 Depending upon the realities of the standards environment, the needs of stakeholders, and available
15 resources, it is envisioned that a mechanism will be established to monitor progress to implement the
16 roadmap’s recommendations.
17 Ultimately, the aim of such efforts would be to continue to guide, coordinate, and enhance
18 standardization activity and enable the market for additive manufacturing to thrive.
19
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1 Appendix A. Glossary of Acronyms and Abbreviations
2
2D Two-dimensional
3D Three-dimensional
3MF 3D manufacturing format
3MF 3MF Consortium
AAMI Association for the Advancement of Medical Instrumentation
AATB American Association of Tissue Banks
ABS ABS group
ACR American College of Radiology
AFRL U.S Air Force Research Laboratory
AI Artificial intelligence
AIA Aerospace industries association
AM Additive manufacturing
AMDC Additive Manufacturing Data Consortium (SAE-ITC)
AME Additively manufactured electronics
AMF Additive manufacturing file format
AMMT Advanced Materials and Manufacturing Technologies
AMMTO Advanced Materials and Manufacturing Technology Office
AMO Advanced manufacturing office
AMO Advanced manufacturing office
AMPP Association for Materials Protection and Performance
AMSP Additive manufacturing service platform
ANSI American national standards institute
ANT Advanced nuclear technology
API Application programming interface
API American Petroleum Institute
ARL Applied Research Laboratory (Penn state)
ARP Aerospace recommended practice (SAE)
ASM ASM international
ASME American Society of Mechanical Engineers
ASSP American Society of Safety Professionals
ASTM ASTM international
AWS American Welding Society
BINDT British Institute of Non-Destructive Testing
BJAM Binder jetting additive manufacturing
BNCS Board on Nuclear Codes and Standards
BPTCS Board on Pressure Technology Codes and Standards
BPVC Boiler and Pressure Vessel Code
CAD Computer aided design
CAE Computer-aided engineering
CAM Computer-aided manufacturing
CBM Condition-based maintenance
CD Committee draft (ISO)
CDA Clinical document architecture
CDD Common data dictionary
CFR Code of Federal Regulations
CM4QC Computational Materials for Qualification and Certification
CM4QC Computational Materials for Qualification and Certification Steering Group
CMDS Consortium for Materials Data Standardization
CMDS Consortium for Materials Data Standardization (ASTM)
CMH Composite material handbook (i.e. CMH-17)
CMM Coordinate measuring machines
CMMS Computerized maintenance management software
CMS Coordinate measuring systems
CoE Center of excellence
CR Computed radiography
CRADA Cooperative research & development agreements
CSG Constructive solid geometry
CT Computed tomography
DA Data (ANSI AMSC)
DE Design (ANSI AMSC)
DED Directed energy deposition
DED-EB Electron beam directed energy deposition
DED-GMA Gas metal arc (DED process)
DED-GTA Gas tungsten arc (DED process)
DED-LB Laser beam directed energy deposition
DED-PA Plasma arc (DED process)
DFAM Design for additive manufacturing
DFARS Defense federal acquisition regulation supplement
DFMA Design for Manufacture and Assembly
DHS U.S. Department of Homeland Security
DIN Deutsches Institut für Normung
DIS Draft international standard (ISO)
DIW Direct ink wiring
DLP Digital light processing
DMA Dynamic mechanical analysis
DMSC Dimensional Metrology Standards Consortium (QIF)
DoD U.S. Department of Defense
DR Digital radiography
DSC Differential scanning calorimetry
DTS Draft technical specification (ISO)
EASA European union aviation safety agency
ECAD Electrical computer-aided design
EEE Electrical, Electronic, and Electromechanical
EFCP Equipment and Facility Control Plan
EHS Environmental health and safety
ELI Extra low interstitial
EMB Engineering in Medicine and Biology (IEEE)
EN European norm
EPA U.S. Environmental Protection Agency
EPRI Electric power research institute
ETL Extract, transform, load
ETWG Emerging technology work group
FAA U.S. Federal Aviation Administration
FAIR Findable, Accessible, Interoperable and Reusable
FDA U.S. Food and Drug Administration
FDM Fused deposition modeling
FFF Fused filament fabrication
FGM Functionally graded materials
FMP Finished material properties
FR Flame retardant
FST Flame, smoke, toxicity
FTIR Fourier transform infrared
GAO U.S. General Accounting Office
GCC General coordination committee
GD&T Geometric dimensioning and tolerancing
GPS Geometrical product specifications
GSG Government steering group
HDF The HDF group
HFIR High-flux Isotope Reactor
HIP Hot isostatic pressing
HIPPA Health Insurance Portability and Accountability
HL7 Hl7 international
HT Heat treatment
ICNDT International Committee for Non-Destructive Testing SIG)
ID Identification
IEC International electrotechnical commission
IEDO Industrial Efficiency and Decarbonization Office
IEEE Institute of Electrical and Electronics Engineers
IETF Internet engineering task force
IGA Intergranular attack
IGO Integranular oxidation
INL Advanced Test Reactor at Idaho National Laboratory
IPC Association connecting electronics industries
IQ Installation qualification
IQI Image quality indicators
ISFA International symposium on flexible automation
ISMS Information security management systems
ISO International Organization for Standardization
ISTO Industry Standards and Technology Organization (IEEE)
IT Information technology
JMADD Joint metals additive database definition
LANL Los Alamos National Laboratory
LCC Life cycle cost
LORA Level of repair analysis
MAPOD Model-assisted POD
MCAD Mechanical computer-aided design
MDR Meta data registries
MES Manufacturing execution system
MIT Massachusetts Institute of Technology
MITA Medical imaging & technology alliance
MMPDS Metallic Materials Properties Development and Standardization (Handbook)
MPIF Metal powder industries federation
MQTT Message queuing telemetry transport
MRI Magnetic resonance imaging
MRO Maintenance, repair and operations
MRR Manufacturing readiness review
MTDA Montana digital academy
NASA National Aeronautics and Space Administration
NAWC Naval Air Warfare Center
NCAMP National Center for Advanced Materials Performance
NDE Nondestructive evaluation
NDI Nondestructive inspection
NDIA National Defense Industrial Association
NDT Nondestructive testing
NE Nuclear energy
NEI Nuclear energy institute
NEMA National Electrical Manufacturers association
NFPA National Fire Protection Association
NIH National Institute of Health
NIOSH National Institute for Occupational Safety and Health
NIST National Institute of Standards and Technology
NNSA National Nuclear Security Agency (doe)
NRC Nuclear Regulatory Commission
OBJ Object file
OQ Operations qualification
ORNL Oak Ridge National Laboratory
OSHA The Occupational Safety and Health Administration
OT Operational technology
OTJ On the job
PAEK Polyaryl ether ketones
PBF Power bed fusion
PBF-EB Electron beam powder bed fusion
PBF-L Laser based powder bed fusion
PBF-LB Laser powder bed fusion
Pc Peak count
PC Process control
PC Polycarbonate (polymer)
PCB Printed circuit boards
PCD Process control documents
PCRT Process compensated resonance testing
PDF Portable document format
PEI Polyetherimide (polymer)
PHM Prognostics and Health Management
PJP Plastics jet printing
PLA Polylactic acid (polymer)
PLC Programmable logic controller
PM Powder metallurgy
PMC Polymer matrix composites
POD Probability of detection
PPP Part production plan
PQ Performance qualification
PRC Product representation compact
PSDO Partner standards developing organization (ASTM/ISO)
PT Project team (ASME)
PT Penetrant testing
PTB Pressure technology book (ASME)
PWG Printer working group
PWI Preliminary work item (ISO)
Q&C Qualification and certification
QA Quality assurance
QC Qualification and certification (ANSI AMSC)
QIF Quality information framework
QMP Qualified material process
QMS Quality management system
QPC Quality and process control
QPP Qualified part process
R&D Research and development
R&R Repeatability and reproducibility
Ra Roughness
RCM Reliability centered maintenance
ROI Regions of interest
RQI Representative quality indicators
Rsm Mean profile spacing
RSNA Radiological Society of North America
RT Radiographic testing
RUS Resonant ultrasonic spectroscopy
S/N Serial number
SABIC SABIC
SAE SAE international
SAR Source approval request
SDO Standards development organization
SIG Special interest group (RSNA)
SLA Stereolithography
SLM Selective laser melting
SLS Selective laser sintering
SMR Small modular reactor
SPC Statistical process control
STD Standard
STEP Standard for the Exchange of Product Data
STL Stereolithography / standard tessellation language
SYSCOM Systems Command (DoD)
T&I Testing and inspection
TC Technical committee
TCR Transformational challenge reactor
TDP Technical data packages (defense sector)
Tg Glass transition temperature
TGA Thermogravimetric analysis
TMA Thermomechanical analysis
TR Technical report (ASTM, ISO)
TRISO Tri-structural isotropic
TS Technical specification (ISO)
UA Unified architecture
UID Unique identification
UL Underwriters laboratory
UNS Unified numbering system
URL Uniform resource locator
USP United states pharmacopeia
UT Ultrasonic testing
V&V Verification and validation
V3 Version 3 (ANSI AMSC)
VDI The Association of German Engineers
VOC Volatile organic chemicals
VRML Virtual reality modeling language
VT Visual testing
VVUQ Verification, validation and uncertainty qualification
WAAM Wire arc AM
WG Working group
WK Work item (ASTM)
X3D Extensible 3D
XCT X-ray computed tomography
XML Extensible markup language
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What organizations are involved in developing standards for additive manufacturing?

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America Makes & ANSI Additive Manufacturing Standardization

Organization Name of Individual(s)

12 Significant Changes from Version 2.0

19 High-Level Structural and Content Changes

28 Repositioned v2 Roadmap Sections/Subsections

4 * priority in terms of desired timeframes for having a published standard

5 Breakdown of Open Gaps by Lifecycle Area

Section High Priority Medium Priority Low Priority Total

8 - Gap DE1: Decision Support: Additive vs. Traditional

12 Withdrawn v2 Gaps (8)

13 - Gap D6: Software-encodable/Machine-readable Guidelines

5 DE – Design (2.1) 10 QC – Qualification & Certification (2.3)

Section # Gap #, Title and Description High Medium Low

10 The process for making production AM parts may be summarized as follows:

11  Design the part for AM

22 1.1 Background on the AMSC and Catalyst for this Roadmap

18  SDOs in identifying opportunities to coordinate and collaborate.

26 1.3 Roadmap Structure

18 Table 1: Prioritization Matrix

Criticality (Safety/Quality Implications). How important is the 3 - critical

Scope (Investment of Resources). Will the project require a

10 The final chapter briefly describes next steps.

11 1.4 List of Organizations Covered in this Roadmap

3MF 3MF Consortium

27 2.1.2 Design Guides

3 2.1.2.1 General Guides for AM

7  ISO/ASTM 52910-18, Additive manufacturing — Design — Requirements, guidelines and

13  ASTM WK83512, Revision of ISO/ASTM52910-18 Additive manufacturing — Design —

19 R&D Needed: ☐Yes; ☒No; ☐Maybe

20 R&D Expectations: N/A

26 Priority: High; Medium; ☐ Low

27 Organization: ISO/ASTM, AWS, SAE, SME, ASME

28 Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished

31 Sectors: ☒All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☐Electronics;

4 Q&C Category: ☐Materials; ☐Processes/Procedures; ☐Machines/Equipment; ☐Parts/Devices;

6 Current Alternative: Organizational level internal evaluations, traditional manufacturing decision-

10 V3 Update: See standards activity above. Commercial tools are available.

20 R&D Needed: ☐Yes; ☒No; ☐Maybe

21 R&D Expectations: N/A

25 Priority: ☐High; ☒Medium; ☐Low

28 Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished

31 Sectors: ☒All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☐Electronics;

4 Q&C Category: ☐Materials; ☐Processes/Procedures; ☐Machines/Equipment; ☐Parts/Devices;

6 Current Alternative: Organizational level internal evaluations

13 2.1.2.2 Process-Specific Guides for AM

19 R&D Needed: ☐Yes; ☐No; ☒Maybe

24 Priority: ☐High; ☒Medium; ☐Low

25 Organization: ASTM F42/ISO TC 261 JG 57, AWS

26 Lifecycle Area: ☒Design; ☐Precursor Materials; ☐Process Control; ☐Post-processing; ☐Finished

29 Sectors: ☒All/Sector Agnostic; ☐Aerospace; ☐Automotive; ☐Construction; ☐Defense; ☐Electronics;

31 Material Type: ☒All/Material Agnostic; ☐Metal; ☐Polymer; ☐Ceramic; ☐Composite

3 Current Alternative: Organizational level internal practices.

8 2.1.2.3 Design Guides for Specific Applications