Designation: F 1537 07

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 F 1537; 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*
1.1 This specification covers the chemical, mechanical, and
metallurgical requirements for three wrought cobalt28chromium-6molybdenum alloys used for surgical implants.
The properties specified apply specifically to wrought bar, rod,
and wire.
1.2 The values stated in inch-pound units are to be regarded
as the standard. The SI equivalents in parentheses are for
information only.

AMS 2269 Chemical Check Analysis Limits, Nickel,

Nickel Alloys and Cobalt Alloys
AMS 2630 Ultrasonic Inspection
2.3 ISO Standards:4
ISO 583212 Implants for SurgeryMetallic Materials
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
ISO 6892 Metallic Materials Tensile Testing at Ambient
Temperature
ISO 9001 Quality Management SystemsRequirements
2.4 American Society for Quality Standard:5
ASQ C1 Specification of General Requirements for a Quality Program

2. Referenced Documents
2.1 ASTM Standards: 2
E 8 Test Methods for Tension Testing of Metallic Materials
E 18 Test Methods for Rockwell Hardness of Metallic
Materials
E 29 Practice for Using Significant Digits in Test Data to
Determine Conformance with Specifications
E 112 Test Methods for Determining Average Grain Size
E 354 Test Methods for Chemical Analysis of HighTemperature, Electrical, Magnetic, and Other Similar Iron,
Nickel, and Cobalt Alloys
F 75 Specification for Cobalt-28 Chromium-6 Molybdenum
Alloy Castings and Casting Alloy for Surgical Implants
(UNS R30075)
F 799 Specification for Cobalt-28Chromium-6Molybdenum
Alloy Forgings for Surgical Implants (UNS R31537,
R31538, R31539)
2.2 Aerospace Material Specifications:3
AMS 2248 Chemical Check Analysis Limits, Corrosion
and Heat Resistant Steels and Alloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys

3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lotthe total number of mill products produced from
the same melt heat under the same conditions at essentially the
same time.

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4. Ordering Information
4.1 Inquiries and orders for material under this specification
shall include the following information:
4.1.1 Quantity,
4.1.2 ASTM designation, alloy number, and date of issue,
4.1.3 Mechanical properties (See Section 7),
4.1.4 Form (bar, rod or wire),
4.1.5 Applicable dimensions including size, thickness,
width, and length (exact, random, or multiples) or drawing
number,
4.1.6 Condition (See Section 5),
4.1.7 Special tests (if any), and
4.1.8 Other requirements.
5. Materials and Manufacture
5.1 Product shall be furnished as specified below:
5.1.1 The annealed condition is typically supplied as a hot
rolled and annealed product.

This specification is under the jurisdiction of ASTM Committee F04 on

Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved July 1, 2007. Published August 2007. Originally
approved in 1994. Last previous edition approved in 2000 as F 1537 00.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM
Standards volume information, refer to the standards Document Summary page on
the ASTM website.
3
Available from Society of Automotive Engineers (SAE), 400 Commonwealth
Dr., Warrendale, PA 15096-0001, http://www.sae.org.

4
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
5
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Milwaukee, WI 53203, http://www.asq.org.

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

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F 1537 07
TABLE 2 Product Analysis TolerancesA,B

5.1.2 The hot worked condition is typically supplied as a hot

rolled and unannealed product.
5.1.3 The warm worked condition is typically supplied as a
thermomechanically processed product to achieve a strainhardened structure.
6. Chemical Requirements
6.1 The cobalt-28chromium-6molybdenum alloys shall conform to the chemical requirements prescribed in Table 1. The
supplier shall not ship material that is outside the limits
specified in Table 1 for the applicable alloy.
6.1.1 Requirements for the major and minor elemental
constituents are listed in Table 1. Also listed are important
residual elements. Analysis for elements not listed in Table 1 is
not required to verify compliance with this specification.
6.2 Product AnalysisThe product analysis is either for the
purpose of verifying the composition of a heat or lot or to
determine variations in the composition within the heat.
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
analysis.
6.2.2 Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between
laboratories in the measurement of chemical content. Product
analysis limits shall be as specified in Table 2.

Element

Permissible Variation Under the Minimum

Limit or Over the Maximum Limit, % (mass/
mass)C

Carbon
Aluminum # 0.50
Aluminum > 0.50 up to 1.00
Lanthanum
Chromium
Molybdenum
Nickel
Iron
Silicon
Manganese
NitrogenD

0.02
0.05
0.10
0.01
0.30
0.15
0.05
0.03
0.05
0.03
0.02

See Test Methods E 354.

Refer to AMS 2269 for chemical check analysis limits (except nitrogen).
For elements in which only a maximum percentage is indicated, the under
minimum limit is not applicable.
D
Refer to AMS 2248.
B

7.1.3 The mechanical properties of test specimens shall

conform to the requirements specified in Table 3.
7.2 Hardness:
7.2.1 Hardness values shall be determined in accordance
with Test Methods E 18.
7.2.2 Hardness values are for information only and shall not
be used as a basis for rejection.
8. Special Tests
8.1 Bar, rod, and wire conforming to this specification shall
have a homogeneous microstructure with an average grain size
of ASTM No. 5 or finer when measured in accordance with
Test Methods E 112.
8.2 Ultrasonic inspection shall be per AMS 2630, Class A1.

7. Mechanical Requirements
7.1 Tensile Properties:
7.1.1 Perform at least two tension and two bend tests from
each lot. Should any of these test pieces not meet the specified
requirements, test two additional test pieces representative of
the same lot, in the same manner, for each failed test piece. The
lot shall be considered in compliance only if all additional test
pieces meet the specified requirements.
7.1.2 Tensile test results for which any specimen fractures
outside the gauge length shall be considered acceptable, if both
the elongation and reduction of area meet the minimum
requirements specified. Refer to subsections 7.11.4 and 7.11.5
of Test Methods E 8.

9. Significance of Numerical Limits

9.1 The following applies to all specified numerical limits in
this specification. To determine conformance to these limits, an
observed or calculated value shall be rounded to the nearest
unit in the last right hand digit used in expressing the
specification limit, in accordance with the rounding method of
Practice E 29.

TABLE 1 Chemical Composition

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Element

Carbon
Aluminum
Lanthanum
Chromium
Molybdenum
Nickel
Iron
Silicon
Manganese
Nitrogen
CobaltA

Composition % (mass/mass)

TABLE 3 Mechanical Requirements

Alloy 1
UNS R31537
(Low Carbon)

Alloy 2
UNS R31538
(High Carbon)

Alloy 3
UNS R31539
(Dispersion
Strengthened)

min
max
......
0.14
......
......
......
......
26.0
30.0
5.0
7.0
......
1.0
......
0.75
......
1.0
......
1.0
......
0.25
Balance

min
max
0.15
0.35
......
......
......
......
26.0
30.0
5.0
7.0
......
1.0
......
0.75
......
1.0
......
1.0
......
0.25
Balance

min
max
......
0.14
0.30
1.00
0.03
0.20
26.0
30.0
5.0
7.0
......
1.0
......
0.75
......
1.0
......
1.0
......
0.25
Balance

Condition

Annealed
Hot
Worked
Warm
Worked

Yield
Strength
(0.2 %
offset),
min, psi
(MPa)

ElongationA
min, %

Reduction
in Area
min, %

Hardness
HRC,
Typical

130 000
(897)
145 000
(1000)
170 000
(1172)

75 000
(517)
101 000
(700)
120 000
(827)

20

20

25

12

12

28

12

12

35

A
Elongation of material 0.062 in. (1.575 mm) or greater in diameter or thickness
shall be measured using a gauge length of 2 in. or 4D or 4W. The gauge length
must be reported with the test results. The method for determining elongation of
material under 0.062 in. (1.57 mm) in diameter or thickness may be negotiated.
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
is the original cross sectional area).

A
Approximately equal to the difference of 100 % and the sum percentage of the
other specified elements. The percentage of cobalt difference is not required to be
reported.

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Ultimate
Tensile
Strength
min, psi
(MPa)

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F 1537 07
12. Keywords

10. Certification
10.1 The supplier shall provide a certification that the
material was manufactured and tested in accordance with the
requirements of this specification. A report of the test results
shall be furnished to the purchaser at the time of shipment.

12.1 cobalt alloys (for surgical implants); cobalt28chromium-6molybdenum; metals (for surgical implants)

11. Quality Program Requirements

11.1 The alloy supplier shall maintain a quality program
such as that which is defined in ASQ C1 or other recognized
quality management system such as ISO 9001.

APPENDIXES
(Nonmandatory Information)
X1. RATIONALE

X1.1 The purpose of this specification is to characterize

composition and properties to ensure consistency in wrought
cobalt-28chromium-6molybdenum bar, rod, and wire used in
the manufacturing of medical devices.

X1.4 The minimum mechanical properties of wrought bar,

rod, and wire conforming to this specification are superior to
the minimum mechanical properties of Specification F 75
material in the as-cast condition.

X1.2 The carbon content of commercially available F 1537

barstock varies to meet specific customer needs. The chemical
composition was expanded into low and high carbon alloys
(Alloys 1 and 2 in Table 1). Alloy 2 contains a greater volume
fraction of carbides compared to Alloy 1.

X1.5 Some complex metallic phases, such as carbides,

oxides, or carbonitrides, or combinations thereof, may be
present in the microstructure of this alloy.
X1.6 ISO standards are listed for reference only. Although
the ISO 583212 standard listed in Section 2 is similar to the
corresponding ASTM standard, they are not identical. Use of
the ISO standard instead of the preferred ASTM standard may
be agreed upon between purchaser and supplier. The mechanical properties of warm-worked condition material, subsection
5.1.3, of this specification are equivalent to the ISO 583212
cold-worked condition.

X1.3 Alloy 3 was added in Table 1 since bar, rod, and wire
produced with this composition meet the current ASTM F 1537
requirements. Alloy 3 is a dispersion-strengthened alloy containing fine aluminum-lanthanum oxides/nitrides.6,7
6
Wang, K. K., Gustavson, L. J., and Dumbleton, J. H., U.S. Patent #4,668,290,
Dispersion Strengthened Cobalt-Chromium-Molybdenum Alloy Produced By Gas
Atomization, Filed August 13, 1985, Issued May 26, 1987.
7
Wang, K. K., Gustavson, L. J., and Dumbleton, J. H., The Development of a
New Dispersion Strengthened Vitallium Alloy for Medical Implants, Modern
Developments in Powder Metallurgy, Volume 20, 1988, pp. 361-375, Metal Powder
Industries Federation, 105 College Road East, Princeton, NJ 08540-6692

X1.7 Wrought material, typically hot-worked and unannealed with a surface suitable for forging, shall be fabricated
and supplied in accordance with this specification when used as
forging stock in the manufacture of forgings in accordance
with Specification F 799.

X2. BIOCOMPATIBILITY

X2.1 The alloy compositions covered by this specification

have been employed successfully in human implant applications in contact with soft tissue and bone for over a decade
(reference 510k #K852964 for Alloy 3, which has been used
since 1985).

shown to be completely free of adverse reactions in the human

body. Long term clinical experience of the use of the material
referred to in this specification, however, has shown that an
acceptable level of biological response can be expected, if the
material is used in appropriate applications.

X2.2 No known surgical implant material has ever been

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F 1537 07
SUMMARY OF CHANGES
Committee F04 has identified the location of selected changes to this standard since the last issue
(F 1537 00) that may impact the use of this standard. (Approved July 1, 2007.)
(1) The value in Table 3 of 1172 MPa was incorrectly
published as 1192 MPa in the 2000 version of the standard and
was corrected with this edition.

(2) Editorial corrections have been made in order to meet

terminology and formatting guidelines established for implant
material standards.

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