Designation: F 75 – 01

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* 2.3 ISO Standards:8

1.1 This specification provides the requirements for ISO 5832-4 Implants for Surgery—Metallic Materials—
cobalt-28 chromium-6 molybdenum alloy unfinished invest- Part 4: Cobalt-Chromium-Molybdenum Casting Alloy
ment product castings for surgical implant applications and ISO 6892 Metallic Materials Tensile Testing at Ambient
casting alloy in the form of shot, bar, or ingots to be used in the Temperature
manufacture of surgical implants. This specification does not 2.4 American Society for Quality Standard:9
apply to completed surgical implants made from castings. ASQ Cl Specification of General Requirements for a Qual-
1.2 The values stated in inch-pound units are to be regarded ity Program
as the standard. The SI equivalents of inch-pound units may be 3. Ordering Information
approximate.
3.1 Inquiries and orders for material under this specification
2. Referenced Documents shall include the following information:
2.1 ASTM Standards: 3.1.1 Quantity (number of product castings or weight of
E 3 Practice for Preparation of Metallographic Specimens2 casting alloy),
E 8 Test Methods for Tension Testing of Metallic Materials2 3.1.2 ASTM designation and date of issue,
E 18 Test Methods for Rockwell Hardness and Rockwell 3.1.3 Form (product casting, shot, bar, ingot),
Superficial Hardness of Metallic Materials2 3.1.4 Applicable dimensions or drawing number,
E 165 Test Method for Liquid Penetrant Examination3 3.1.5 Condition (as-cast, hot isostatically pressed (HIP),
E 407 Practice for Microetching Metals and Alloys2 solution annealed, and so forth),
E 601 Practice for Fluorescent Penetrant Inspection of Me- 3.1.6 Special tests, if any, and
tallic Surgical Implants4 3.1.7 Other requirements.
E 629 Practice for Radiography of Cast Metallic Surgical
4. Materials and Manufacturing Requirements for
Implants5
Product Castings
F 981 Practice for Assessment of Compatibility of Bioma-
terials for Surgical Implants with Respect to Effect of 4.1 Final thermal processing for castings, if any, shall be
Materials on Muscle and Bone6 specified by mutual agreement between the supplier and
2.2 Aerospace Material Specification:7 purchaser.
AMS 2248 Chemical Check Analysis Limits: Corrosion and 4.2 Castings shall be free of visible investment shell mate-
Heat Resistant Steels and Alloys, Maraging and Other rial and scale when examined without magnification.
Highly-Alloyed Steels, and Iron Alloys 4.3 Welding may be used to repair castings as agreed upon
AMS 2269 Chemical Check Analysis Limits: Nickel, between supplier and purchaser.
Nickel Alloys and Cobalt Alloys 4.3.1 Weld repair shall be performed in accordance with
written procedures by individuals certified to perform those
procedures.
1
This specification is under the jurisdiction of ASTM Committee F04 on 4.3.2 Weld filler metal conforming to the chemistry of Table
Medical and Surgical Materials and Devices and is the direct responsibility of 1 shall be used when it is needed.
Subcommittee F04.12 on Metallurgical Materials.
4.3.3 Weld repair, if any, shall be performed before final
Current edition approved Dec. 10, 2001. Published February 2002. Originally
published as F 75 – 67. Last previous edition F 75 – 98. thermal processing.
2
Annual Book of ASTM Standards, Vol 03.01.
3
Annual Book of ASTM Standards, Vol 03.03.
4
Annual Book of ASTM Standards, Vol 14.03.
5 8
Discontinued; See 1996 Annual Book of ASTM Standards, Vol 11.05. Available from American National Standards Institute, 25 W. 43rd St., 4th
6
Annual Book of ASTM Standards, Vol 13.01. Floor, New York, NY 10036.
7 9
Available from Society of Automotive Engineers, 400 Commonwealth Dr., Available from American Society for Quality, 600 N. Plankinton Ave.,
Warrendale, PA 15096-0001. Milwaukee, WI 53203.

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

Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.

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 F 75 – 01
TABLE 1 Chemical Composition TABLE 2 Product Analysis TolerancesA
Composition, % (Mass/Mass) Tolerance,B,C
Element Element
% (Mass/Mass)
min max
Chromium 0.30
Chromium 27.00 30.00
Molybdenum 0.15
Molybdenum 5.00 7.00
Nickel 0.05
Nickel ... 0.50
Iron 0.03
Iron ... 0.75
Carbon 0.02
Carbon ... 0.35
Silicon 0.05
Silicon ... 1.00
Manganese 0.03
Manganese ... 1.00
Tungsten 0.04
Tungsten ... 0.20
Phosphorous 0.005
Phosphorous ... 0.020
Sulfur 0.003
Sulfur ... 0.010
Nitrogen 0.02D
Nitrogen ... 0.25
Aluminum 0.02
Aluminum ... 0.10
Titanium 0.02
Titanium ... 0.10
Boron 0.002
Boron ... 0.010
A
Cobalt balance balance Refer to AMS Standard 2269 for chemical check analysis limits.
B
Under the minimum limit or over the maximum limit.
C
For elements in which only a maximum percentage is indicated, the “under
minimum limit” is not applicable.
D
Refer to AMS 2248 for chemical check analysis limits.
NOTE 1—Under certain circumstances, a weld repair may act as a stress
riser. Therefore, care should be exercised in the location and extent of TABLE 3 As-Cast Mechanical Requirements
weld repair as it relates to regions of the implant where significant stresses
Property
might occur.
Ultimate tensile strength, min, psi (MPa) 95 000 (655)
Yield strength, (0.2 % offset), min, psi (MPa) 65 000 (450)
5. Chemical Requirements Elongation,A min, % 8
5.1 Both product castings and casting alloy shall conform to Reduction of area, min, % 8
the chemical requirements prescribed in Table 1. The supplier A
Elongation of material 0.062 in. (1.575 mm) or greater in diameter (D) or width
shall not ship material that is outside the limits specified in (W) shall be measured using a gage length of 2 in. or 4D or 4W. The gage length
must be reported with the test results. The method for determining elongation of
Table 1. Chemical analysis shall be performed on a represen- material under 0.062 in. (1.575 mm) in diameter or thickness may be negotiated.
tative specimen cast from each master heat using the same Alternately, a gage length corresponding to ISO 6892 may be used when agreed
upon between supplier and purchaser. (5.65=So, where So is the original
general procedures used in casting implants. cross-sectional area.)
5.1.1 Requirements for the major and minor elemental
constituents are listed in Table 1. Also listed are important
residual elements. Analysis is not required for elements, which 6.1.4 Tension test results for which any specimen fractures
are not listed in Table 1, to verify compliance with this outside the gage length shall be considered invalid and a
specification. replacement specimen shall be tested in accordance with Test
5.2 Product Analysis —The product analysis is either for the Methods E 8.
purpose of verifying the composition of a heat or lot or to 6.1.5 If castings are supplied in a heat-treated condition,
determine variations in the composition within the heat. tensile property requirements shall be agreed upon between
5.2.1 Acceptance or rejection of a heat or lot of material supplier and purchaser.
may be made by the purchaser on the basis of this product 6.2 Tensile Properties for Casting Alloy:
analysis. 6.2.1 As-cast material shall conform to the mechanical
5.2.2 Product analysis tolerances do not broaden the speci- property requirements given in Table 3 when tested in accor-
fied chemical requirements but instead cover variations be- dance with Test Methods E 8.
tween laboratories in the measurement of chemical content. 6.2.2 Tension test specimens shall be melted and cast under
Product analysis limits shall be as specified in Table 2. casting procedures agreed upon between supplier and pur-
chaser.
6. Mechanical Requirements 6.2.3 A minimum of two tension test specimens per master
6.1 Tensile Properties for Product Castings: heat shall be tested. If one specimen fails the specified
6.1.1 As-cast material shall conform to the mechanical mechanical requirements, two additional specimens shall be
property requirements given in Table 3 when tested in accor- tested and both must pass.
dance with Test Methods E 8. 6.2.4 Tension test results for which any specimen fractures
6.1.2 Tension test specimens shall be melted and cast from outside the gage length shall be considered acceptable, if the
each master heat by the same general procedures used in reduction of area meets the minimum requirements specified. If
casting the surgical implants or machined from surgical im- the reduction of area is less than the minimum requirement,
plant castings. discard the test results and retest.
6.1.3 A minimum of two tension test specimens per heat
shall be tested. If one specimen fails the specified mechanical 7. Special Testing for Product Castings
requirements, two additional specimens shall be tested and 7.1 Liquid Penetrant Examination—Sampling plans and
both must pass. acceptance criteria shall be mutually agreed upon by supplier

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 F 75 – 01
and purchaser. Individual parts should be examined in accor- 8. Certification
dance with Practice F 601 or Test Method E 165, as appropriate 8.1 A certification, including a complete test report, shall be
for the surface condition of the casting being tested. provided by the supplier at the time of shipment stating that the
7.2 Radiographic Examination—Sampling plans and accep- product castings or the casting alloy were manufactured and
tance criteria shall be mutually agreed upon by supplier and tested in accordance with this specification.
purchaser. Radiographic examination shall be in accordance 8.2 If the supplier and purchaser are one and the same,
with Practice F 629. equivalent internal documentation shall be acceptable in lieu of
7.3 Metallography—The microstructural requirements and certification.
frequency of examinations shall be mutually agreed upon by
supplier and purchaser. Specimen preparation shall be in 9. Quality Program Requirements
accordance with Practices E 3 and E 407. 9.1 The foundry, its ingot suppliers, any processors and
7.4 Hardness: distributors shall all maintain quality programs, such as is
7.4.1 Materials conforming to this specification will typi- defined in ASQ C1.
cally have a hardness of 25 to 35 HRC in the as-cast condition.
The hardness determination shall be performed in accordance 10. Keywords
with Test Methods E 18. 10.1 castings—surgical; cobalt alloys (for surgical im-
7.4.2 Hardness values are for information only and shall not plants); cobalt-chromium-molybdenum-metals (for surgical
be used as criteria for rejection. implants); cobalt alloys

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 7.
castings they represent.
X1.5 Beacuse 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
F 981. material is used in appropriate applications.

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 F 75 – 01
SUMMARY OF CHANGES

(1) Changes from the previous document include a change in separate testing controls for cast product to Section 6, and
the title and the addition of requirements for casting product adding penetrant inspection, radiographic inspection, and met-
throughout the document. These changes include: adding allographic inspection to Section 7.
Practice E 3, Test Method E 165, Practices E 407, F 601, (2) Editorial corrections have been made to meet terminology
F 629, ISO 5832-4, and ISO 6892 to Section 2, adding thermal and formatting guidelines established for implant material
processing and weld repair to Section 4, adding a chemical standards.
requirement to control titanium content to Section 5, adding

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