Designation: F 75 – 07

Standard Specification for

Cobalt-28 Chromium-6 Molybdenum Alloy Castings and
Casting Alloy for Surgical Implants (UNS R30075)1
This standard is issued under the fixed designation F 75; 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 (e) indicates an editorial change since the last revision or reapproval.

1. Scope* 2.2 Aerospace Material Specification:4

1.1 This specification covers the requirements for cobalt-28 AMS 2248 Chemical Check Analysis Limits: Corrosion and
chromium-6 molybdenum alloy unfinished investment product Heat Resistant Steels and Alloys, Maraging and Other
castings for surgical implant applications and casting alloy in Highly-Alloyed Steels, and Iron Alloys
the form of shot, bar, or ingots to be used in the manufacture AMS 2269 Chemical Check Analysis Limits: Nickel,
of surgical implants. This specification does not apply to Nickel Alloys and Cobalt Alloys
completed surgical implants made from castings. 2.3 ISO Standards:5
1.2 The values stated in inch-pound units are to be regarded ISO 5832-4 Implants for Surgery—Metallic Materials—
as the standard. The SI equivalents in parentheses are for Part 4: Cobalt-Chromium-Molybdenum Casting Alloy
information only. ISO 6892 Metallic Materials Tensile Testing at Ambient
Temperature
2. Referenced Documents ISO 9001 Quality Management Systems—Requirements
2.1 ASTM Standards: 2 2.4 American Society for Quality Standard:6
A 957 Specification for Investment Castings, Steel and ASQ Cl Specification of General Requirements for a Qual-
Alloy, Common Requirements, for General Industrial Use ity Program
E 3 Guide for Preparation of Metallographic Specimens
3. Terminology
E 8 Test Methods for Tension Testing of Metallic Materials
E 18 Test Methods for Rockwell Hardness and Rockwell 3.1 Definitions of Terms Specific to This Standard:
Superficial Hardness of Metallic Materials 3.1.1 investment casting, n—a metal casting that is pro-
E 29 Practice for Using Significant Digits in Test Data to duced in a mold obtained by investing (surrounding) an
Determine Conformance with Specifications expendable pattern with a ceramic slurry that is allowed to
E 165 Test Method for Liquid Penetrant Examination solidify. The expendable pattern may consist of wax, plastic, or
E 354 Test Methods for Chemical Analysis of High- other material and is removed prior to filling the mold with
Temperature, Electrical, Magnetic, and Other Similar Iron, liquid metal.
Nickel, and Cobalt Alloys 3.1.2 master heat, n—a quantity of metal processed in a
E 407 Practice for Microetching Metals and Alloys single furnace or refining vessel at one time in such a manner
E 601 Test Method for Comparing EMF Stability of Single- as to produce the desired composition and properties.
Element Base-Metal Thermocouple Materials in Air3 3.1.3 sub-heat, n—a portion of a master heat remelted
F 629 Practice for Radiography of Cast Metallic Surgical without additional processing for pouring into castings. Syn-
Implants onyms: melt, production heat.
F 981 Practice for Assessment of Compatibility of Bioma- NOTE 1—Terminology section in accordance with Specification A 957.
terials for Surgical Implants with Respect to Effect of
Materials on Muscle and Bone 4. Ordering Information
4.1 Inquiries and orders for material under this specification
shall include the following information:
1
This specification is under the jurisdiction of ASTM Committee F04 on 4.1.1 Quantity (number of product castings or weight of
Medical and Surgical Materials and Devices and is the direct responsibility of casting alloy),
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Jan. 1, 2007. Published January 2007. Originally
4
approved in 1967. Last previous edition approved in 2001 as F 75 – 01. Available from Society of Automotive Engineers (SAE), 400 Commonwealth
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Dr., Warrendale, PA 15096-0001, http://www.sae.org.
5
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Standards volume information, refer to the standard’s Document Summary page on 4th Floor, New York, NY 10036, http://www.ansi.org.
6
the ASTM website. Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
3
Withdrawn. Milwaukee, WI 53203, http://www.asq.org.

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

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 F 75 – 07
4.1.2 ASTM designation and date of issue, residual elements. Analysis is not required for elements, which
4.1.3 Form (product casting, shot, bar, ingot), are not listed in Table 1, to verify compliance with this
4.1.4 Applicable dimensions or drawing number, specification.
4.1.5 Condition (as-cast, hot isostatically pressed (HIP), 6.2 Product Analysis —The product analysis is either for the
solution annealed, and so forth), purpose of verifying the composition of a heat or lot or to
4.1.6 Special tests, if any, and determine variations in the composition within the heat.
4.1.7 Other requirements. 6.2.1 Acceptance or rejection of a heat or lot of material
may be made by the purchaser on the basis of this product
5. Materials and Manufacturing Requirements for analysis.
Product Castings 6.2.2 Product analysis tolerances do not broaden the speci-
5.1 Final thermal processing for castings, if any, shall be fied chemical requirements but instead cover variations be-
specified by mutual agreement between the supplier and tween laboratories in the measurement of chemical content.
purchaser. Product analysis limits shall be as specified in Table 2.
5.2 Castings shall be free of visible investment shell mate-
7. Mechanical Requirements
rial and scale when examined without magnification.
5.3 Welding may be used to repair castings as agreed upon 7.1 Tensile Properties for Product Castings:
between supplier and purchaser. 7.1.1 As-cast material shall conform to the mechanical
5.3.1 Weld repair shall be performed in accordance with property requirements given in Table 3 when tested in accor-
written procedures by individuals certified to perform those dance with Test Methods E 8.
procedures. 7.1.2 Tension test specimens shall be melted and cast from
5.3.2 Weld filler metal conforming to the chemistry of Table a sub heat of each master heat by the same general procedures
1 shall be used when it is needed. used in casting the surgical implants or machined from surgical
5.3.3 Weld repair, if any, shall be performed before final implant castings.
thermal processing. 7.1.3 Specimens may be cast, ground, or machined to final
dimensions in accordance with the 0.25 in. (6.35 mm) diameter
NOTE 2—Under certain circumstances, a weld repair may act as a stress specimen in Fig. 8 of Test Methods E 8.
riser. Therefore, care should be exercised in the location and extent of
weld repair as it relates to regions of the implant where significant stresses
7.1.4 Perform at least two tension tests per master heat.
might occur. Should any of these test pieces not meet the specified require-
ments, test two additional representative test pieces, in the
6. Chemical Requirements same manner, for each failed test piece. The master heat shall
6.1 Both product castings and casting alloy shall conform to be considered in compliance only if all additional test pieces
the chemical requirements prescribed in Table 1. The supplier meet the specified requirements.
shall not ship material that is outside the limits specified in 7.1.5 Tensile tests results for which any specimen fractures
Table 1. outside the gage length shall be considered acceptable, if both
6.1.1 Chemical analysis shall be performed on a represen- the elongation and reduction of area meet the minimum
tative specimen of a sub heat cast from each master heat using requirements specified. Refer to Test Methods E 8, sections
the same general procedures used in casting implants. 7.11.4 and 7.11.5. If either the elongation or reduction of area
6.1.2 Requirements for the major and minor elemental is less than the minimum requirement, discard the test and
constituents are listed in Table 1. Also listed are important
TABLE 2 Product Analysis TolerancesA,B
Tolerance Under the Minimum
TABLE 1 Chemical Composition Element or Over the Maximum Limit,
% (Mass/Mass)C
Composition, % (Mass/Mass)
Element Chromium 0.30
min max
Molybdenum 0.15
Chromium 27.00 30.00 Nickel 0.05
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Molybdenum 5.00 7.00 Iron 0.03

Nickel ... 0.50 Carbon 0.02
Iron ... 0.75 Silicon 0.05
Carbon ... 0.35 Manganese 0.03
Silicon ... 1.00 Tungsten 0.04
Manganese ... 1.00 Phosphorous 0.005
Tungsten ... 0.20 Sulfur 0.003
Phosphorous ... 0.020 Nitrogen 0.02D
Sulfur ... 0.010 Aluminum 0.02
Nitrogen ... 0.25 Titanium 0.02
Aluminum ... 0.10 Boron 0.002
Titanium ... 0.10 A
See Test Methods E 354.
Boron ... 0.010 B
Refer to AMS Standard 2269 for chemical check analysis limits (except
CobaltA balance balance
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 the cobalt difference is not required to minimum limit” is not applicable.
D
be reported. Refer to AMS 2248 for chemical check analysis limits.

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 F 75 – 07
TABLE 3 As-Cast Mechanical Requirements dance with Test Method F 601 or Test Method E 165, as
Property appropriate for the surface condition of the casting being
Ultimate tensile strength, min, psi (MPa) 95 000 (655) tested.
Yield strength, (0.2 % offset), min, psi (MPa) 65 000 (450) 8.2 Radiographic Examination—Sampling plans and accep-
Elongation,A min, % 8
Reduction of area, min, % 8
tance criteria shall be mutually agreed upon by supplier and
A
purchaser. Radiographic examination shall be in accordance
Elongation of material 0.063 in. (1.6 mm) or greater in diameter (D) or width (W)
shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge length with Practice F 629.
must be reported with the test results. The method for determining elongation of 8.3 Metallography—The microstructural requirements and
material under 0.063 in. (1.6 mm) in diameter or thickness may be negotiated. frequency of examinations shall be mutually agreed upon by
Alternately, a gauge length corresponding to ISO 6892 may be used when agreed
upon between supplier and purchaser. (5.65 times the square root of So, where So supplier and purchaser. Specimen preparation shall be in
is the original cross-sectional area.) accordance with Guide E 3 and Practice E 407.
8.4 Hardness:
8.4.1 Materials conforming to this specification will typi-
retest. Retest one specimen for each specimen that did not meet cally have a hardness of 25 to 35 HRC in the as-cast condition.
the minimum requirements. The hardness determination shall be performed in accordance
7.1.6 If castings are supplied in a heat-treated condition, with Test Methods E 18.
tensile property requirements shall be agreed upon between 8.4.2 Hardness values are for information only and shall not
supplier and purchaser. be used as criteria for rejection.
7.2 Tensile Properties for Casting Alloy:
7.2.1 As-cast material shall conform to the mechanical 9. Significance of Numerical Limits
property requirements given in Table 3 when tested in accor-
9.1 The following applies to all specified numerical limits in
dance with Test Methods E 8.
this specification. To determine conformance to these limits, an
7.2.2 Tension[epsis ] test specimens shall be melted and cast
observed or calculated value shall be rounded to the nearest
from a sub heat of each master heat by the same general
unit in the last right hand digit used in expressing the
procedures used in casting of the surgical implants
specification limit, in accordance with the rounding method of
7.2.3 Specimens may be cast, ground, or machined to final
Practice E 29.
dimensions in accordance with the 0.25 in. (6.35 mm) diameter
specimen in Fig. 8 of Test Methods E 8.
10. Certification
7.2.4 Perform at least two tension tests per master heat.
Should any of these test pieces not meet the specified require- 10.1 A certification, including a complete test report, shall
ments, test two additional representative test pieces, in the be provided by the supplier at the time of shipment stating that
the product castings or the casting alloy were manufactured

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same manner, for each failed test piece. The master heat shall
be considered in compliance only if all additional test pieces and tested in accordance with this specification.
meet the specified requirements. 10.2 If the supplier and purchaser are one and the same,
7.2.5 Tensile tests results for which any specimen fractures equivalent internal documentation shall be acceptable in lieu of
outside the gage length shall be considered acceptable, if both certification.
the elongation and reduction of area meet the minimum
requirements specified. Refer to Test Methods E 8, sections 11. Quality Program Requirements
7.11.4 and 7.11.5. If either the elongation or reduction of area 11.1 The foundry, its ingot suppliers, any processors and
is less than the minimum requirement, discard the test and distributors shall all maintain quality programs, such as is
retest. Retest one specimen for each specimen that did not meet defined in ASQ C1 or other recognized quality management
the minimum requirements. system such as ISO 9001.

8. Special Testing for Product Castings 12. Keywords

8.1 Liquid Penetrant Examination—Sampling plans and 12.1 castings—surgical; cobalt alloys (for surgical im-
acceptance criteria shall be mutually agreed upon by supplier plants); cobalt-chromium-molybdenum-metals (for surgical
and purchaser. Individual parts should be examined in accor- implants); cobalt alloys

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 F 75 – 07
APPENDIXES

(Nonmandatory Information)

X1. RATIONALE

X1.1 The mechanical properties listed in Table 3 are used to castings. This specification is not intended to cover the effects
verify the capability of the alloy to produce castings of of such processes.
acceptable strength and ductility. For consistency of test
results, it is advisable to subject test bars to the same X1.4 If castings are straightened, bent or welded, they may
radiographic and penetrant requirements as will be used for the require subsequent annealing or special testing per Section 8.
castings they represent.
X1.5 Because of the wide variety of devices made from this
X1.2 Cast microstructure and mechanical properties are alloy, 100 % radiographic inspection may not be required.
dependent on cross sectional thickness. The mechanical prop-
erties measured on as-cast 1⁄4-in. diameter test bars may not be X1.6 The approximate ISO standard equivalent for this
the same as those in castings of different cross-sectional material is ISO 5832-4. (Such ISO standards are listed for
thickness. reference only. Although ISO standards are similar to the
corresponding ASTM International standards, they are not
X1.3 Various heat treatments, including hot isostatic press- always identical. Use of an ISO standard in addition to or
ing, solution annealing, and sintering, may be used on instead of a preferred ASTM International standard may be
cobalt-28 chromium-6 molybdenum alloy surgical implant negotiated between purchaser and supplier.)

X2. BIOCOMPATIBILITY

X2.1 The alloy composition covered by this standard has X2.2 No known surgical implant material has ever been
been used successfully in human implant applications in shown to be completely free of adverse reactions in the human
contact with soft tissue and bone for over a decade. Because of body. However, long-term clinical experience of the use of the
the well characterized level of biological response exhibited by material referred to in this standard has shown that an
this alloy, it has been used as a control material in Practice acceptable level of biological response can be expected, if the

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F 981. material is used in appropriate applications.

SUMMARY OF CHANGES

Committee F04 has identified the location of selected changes to this standard since the last issue (F 75 – 01)
that may impact the use of this standard. (Approved Jan. 1, 2007.)

(1) Changes from the previous document include the addition (2) Editorial corrections have been made to meet terminology
of rounding Practice E 29, Test Methods E 354, quality man- and formatting guidelines established for implant material
agement system ISO 9001, and the addition of Section 3, standards.
Terminology.

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