This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles

for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Designation: F1537 − 20

Standard Specification for

Wrought Cobalt-28Chromium-6Molybdenum Alloys for
Surgical Implants (UNS R31537, UNS R31538, and UNS
R31539)1
This standard is issued under the fixed designation F1537; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.

1. Scope* F75 Specification for Cobalt-28 Chromium-6 Molybdenum

1.1 This specification covers the chemical, mechanical, and Alloy Castings and Casting Alloy for Surgical Implants
metallurgical requirements for three wrought cobalt- (UNS R30075)
28chromium-6molybdenum alloys used for surgical implants. F799 Specification for Cobalt-28 Chromium-6 Molybdenum
The properties specified apply specifically to wrought bar, rod, Alloy Forgings for Surgical Implants (UNS R31537,
and wire. R31538, R31539)
IEEE/ASTM SI 10 American National Standard for Metric
1.2 The values stated in either SI units or inch-pound units Practice
are to be regarded separately as standard. The values stated in 2.2 Aerospace Material Specifications:3
each system are not necessarily exact equivalents; therefore, to AMS 2248 Chemical Check Analysis Limits, Corrosion and
ensure conformance with the standard, each system shall be Heat Resistant Steels and Alloys, Maraging and Other
systems shall not be combined. iTeh Standards
used independently of the other, and values from the two Highly-Alloyed Steels, and Iron Alloys
AMS 2269 Chemical Check Analysis Limits, Nickel, Nickel

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1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard-
Alloys and Cobalt Alloys
AMS 2630 Inspection, Ultrasonic Product over 0.5 Inch
ization established in the Decision on Principles for the
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(12.7 mm) Thick
Development of International Standards, Guides and Recom- 2.3 ISO Standards:4
mendations issued by the World Trade Organization Technical ISO 5832–12 Implants for Surgery—Metallic Materials—
Barriers to Trade (TBT) Committee. Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
2. Referenced Documents
ASTM F1537-20
ISO 6892 Metallic Materials - Tensile Testing at Ambient
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Temperature
2.1 ASTM Standards:2 ISO 9001 Quality Management Systems—Requirements
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials 3. Terminology
E18 Test Methods for Rockwell Hardness of Metallic Ma- 3.1 Definitions of Terms Specific to This Standard:
terials 3.1.1 lot—the total number of mill products produced from
E29 Practice for Using Significant Digits in Test Data to the same melt heat under the same conditions at essentially the
Determine Conformance with Specifications same time.
E112 Test Methods for Determining Average Grain Size
E354 Test Methods for Chemical Analysis of High- 4. Ordering Information
Temperature, Electrical, Magnetic, and Other Similar Iron,
4.1 Inquiries and orders for material under this specification
Nickel, and Cobalt Alloys
shall include the following information:
4.1.1 Quantity;
1
This specification is under the jurisdiction of ASTM Committee F04 on 4.1.2 ASTM designation, alloy number, and date of issue;
Medical and Surgical Materials and Devices and is the direct responsibility of 4.1.3 Mechanical properties (see Section 7);
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved March 1, 2020. Published April 2020. Originally
4.1.4 Units to be certified – SI or inch pound;
approved in 1994. Last previous edition approved in 2011 as F1537 – 11. DOI:
10.1520/F1537-20.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Society of Automotive Engineers (SAE), 400 Commonwealth
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM Dr., Warrendale, PA 15096-0001, http://www.sae.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.

*A Summary of Changes section appears at the end of this standard

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1
 F1537 − 20
4.1.5 Form (bar, rod or wire); 6.2.1 Acceptance or rejection of a heat or lot of material
4.1.6 Applicable dimensions including size, thickness, may be made by the purchaser on the basis of this product
width, and length (exact, random, or multiples) or drawing analysis.
number; 6.2.2 Product analysis tolerances do not broaden the speci-
4.1.7 Condition (see Section 5); fied heat analysis requirements but cover variations between
4.1.8 Special tests (if any); and laboratories in the measurement of chemical content. Product
4.1.9 Other requirements. analysis limits shall be as specified in Table 2.
5. Materials and Manufacture 7. Mechanical Requirements
5.1 Product shall be furnished as specified below: 7.1 Tensile Properties:
5.1.1 The annealed condition is typically supplied as a hot 7.1.1 Perform at least two tension tests from each lot.
rolled and annealed product. Should any of these test pieces not meet the specified
5.1.2 The hot worked condition is typically supplied as a hot requirements, test two additional test pieces representative of
rolled and unannealed product. the same lot, in the same manner, for each failed test piece. The
5.1.3 The warm worked condition is typically supplied as a lot shall be considered in compliance only if all additional test
thermomechanically processed product to achieve a strain- pieces meet the specified requirements.
hardened structure. 7.1.2 Tensile test results for which any specimen fractures
6. Chemical Requirements outside the gauge length shall be considered acceptable, if both
the elongation and reduction of area meet the minimum
6.1 The cobalt-28chromium-6molybdenum alloys shall con- requirements specified. Refer to subsections 7.11.4 and 7.11.5
form to the chemical requirements prescribed in Table 1. The of Test Methods E8/E8M.
supplier shall not ship material that is outside the limits 7.1.3 The mechanical properties of test specimens shall
specified in Table 1 for the applicable alloy. conform to the requirements specified in Table 3.
6.1.1 Requirements for the major and minor elemental
constituents are listed in Table 1. Also listed are important 7.2 Hardness:

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residual elements. Analysis for elements not listed in Table 1 is 7.2.1 Hardness values shall be determined in accordance
not required to verify compliance with this specification. with Test Methods E18.
7.2.2 Hardness values are for information only and shall not
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6.1.2 All commercial metals contain small amounts of
elements other than those which are specified. It is neither be used as a basis for rejection.
practical nor necessary to specify limits for unspecified
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8. Microstructure Requirements
elements, whether residual elements or trace elements, that can
be present. The producer is permitted to analyze for unspecified 8.1 Bar, rod, and wire conforming to this specification shall
elements and is permitted to report such analyses. The presence have a homogeneous microstructure with an average grain size
of an unspecified element and the reporting of an analysis for of ASTM No. 5 or finer when measured in accordance with
that element shall not be a basis for rejection.
ASTM F1537-20
Test Methods E112.
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6.1.3 Intentional elemental additions other than those speci-
9. Ultrasonic Inspection
fied in Table 1 are not permitted.
9.1 For finished thicknesses 6.35 mm [0.250 in.] and
6.2 Product Analysis—The product analysis is either for the
greater, inspection shall be per AMS 2630 Class A1. Equiva-
purpose of verifying the composition of a heat or lot or to
lent test methods may be substituted when agreed to by
determine variations in the composition within the heat.
purchaser and supplier. AMS 2630 indicates a minimum size of
TABLE 1 Chemical Composition
Composition % (mass/mass) TABLE 2 Product Analysis TolerancesA,B
Element Alloy 1 Alloy 2 Alloy 3 Element Permissible Variation Under the Minimum
UNS R31537 UNS R31538 UNS R31539 Limit or Over the Maximum Limit, % (mass/
(Low Carbon) (High Carbon) (Dispersion mass)C
Strengthened) Carbon 0.02
min max min max min max Aluminum #0.50 0.05
Carbon ...... 0.14 0.15 0.35 ...... 0.14 Aluminum >0.50 up to 1.00 0.10
Aluminum ...... ...... ...... ...... 0.30 1.00 Lanthanum 0.01
Lanthanum ...... ...... ...... ...... 0.03 0.20 Chromium 0.30
Chromium 26.0 30.0 26.0 30.0 26.0 30.0 Molybdenum 0.15
Molybdenum 5.0 7.0 5.0 7.0 5.0 7.0 Nickel 0.05
Nickel ...... 1.0 ...... 1.0 ...... 1.0 Iron 0.03
Iron ...... 0.75 ...... 0.75 ...... 0.75 Silicon 0.05
Silicon ...... 1.0 ...... 1.0 ...... 1.0 Manganese 0.03
Manganese ...... 1.0 ...... 1.0 ...... 1.0 NitrogenD 0.02
Nitrogen ...... 0.25 ...... 0.25 ...... 0.25 A
See Test Methods E354.
CobaltA Balance Balance Balance B
Refer to AMS 2269 for chemical check analysis limits (except nitrogen).
A C
Approximately equal to the difference of 100 % and the sum percentage of the For elements in which only a maximum percentage is indicated, the “under
other specified elements. The percentage of cobalt difference is not required to be minimum limit” is not applicable.
D
reported. Refer to AMS 2248.