ASTM F1537-20

Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for three wrought cobalt-28chromium-6molybdenum alloys used for surgical implants. The properties specified apply specifically to wrought bar, rod, and wire. The alloys shall conform to the prescribed chemical requirements. Two tension and two bend tests shall be performed on each sample lot to determine tensile properties. 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.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three wrought cobalt-28chromium-6molybdenum alloys used for surgical implants. The properties specified apply specifically to wrought bar, rod, and wire.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.3 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.

General Information

• Status: Published
• Publication Date: 29-Feb-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Mar-2020
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 01-Mar-2020
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Mar-2020
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Mar-2020
• Referred By: ASTM F1377-21 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
• Effective Date: 01-Mar-2020
• Referred By: ASTM F2052-21 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• Effective Date: 01-Mar-2020
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis
• Effective Date: 01-Mar-2020
• Referred By: ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
• Effective Date: 01-Mar-2020
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Mar-2020

Standards Content (Sample)

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
1
R31539)
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
Alloy Castings and Casting Alloy for Surgical Implants
1.1 This specification covers the chemical, mechanical, and
(UNS R30075)
metallurgical requirements for three wrought cobalt-
F799 Specification for Cobalt-28 Chromium-6 Molybdenum
28chromium-6molybdenum alloys used for surgical implants.
Alloy Forgings for Surgical Implants (UNS R31537,
The properties specified apply specifically to wrought bar, rod,
R31538, R31539)
and wire.
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
3
2.2 Aerospace Material Specifications:
each system are not necessarily exact equivalents; therefore, to
AMS 2248 Chemical CheckAnalysis Limits, Corrosion and
ensure conformance with the standard, each system shall be
Heat Resistant Steels and Alloys, Maraging and Other
used independently of the other, and values from the two
Highly-Alloyed Steels, and Iron Alloys
systems shall not be combined.
AMS 2269 Chemical CheckAnalysis Limits, Nickel, Nickel
1.3 This international standard was developed in accor-
Alloys and Cobalt Alloys
dance with internationally recognized principles on standard-
AMS 2630 Inspection, Ultrasonic Product over 0.5 Inch
ization established in the Decision on Principles for the
(12.7 mm) Thick
4
Development of International Standards, Guides and Recom-
2.3 ISO Standards:
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
ISO 6892 Metallic Materials - Tensile Testing at Ambient
2. Referenced Documents
Temperature
2
2.1 ASTM Standards:
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,andOtherSimilarIron,
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.
4.1.4 Units to be certified – SI or inch pound;
Current edition approved March 1, 2020. Published April 2020. Originally
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 [e-mail]. 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 fromAmerican 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
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 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 analys
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1537 − 11 F1537 − 20
Standard Specification for
Wrought Cobalt-28Chromium-6Molybdenum Alloys for
Surgical Implants (UNS R31537, UNS R31538, and UNS
1
R31539)
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*
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for three wrought cobalt-28chromium-
6molybdenum alloys used for surgical implants. The properties specified apply specifically to wrought bar, rod, and wire.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values givenstated
in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.each
system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used
independently of the other, and values from the two systems shall not be combined.
1.3 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E8/E8M Test Methods for Tension Testing of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F799 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
IEEE/ASTM SI 10 American National Standard for Metric Practice
3
2.2 Aerospace Material Specifications:
AMS 2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys
AMS 2269 Chemical Check Analysis Limits, Nickel, Nickel Alloys and Cobalt Alloys
AMS 2630 Inspection, Ultrasonic Product over 0.5 Inch (12.7 mm) Thick
4
2.3 ISO Standards:
ISO 5832–12 Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
ISO 6892 Metallic Materials - Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
1
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 Nov. 15, 2011March 1, 2020. Published December 2011April 2020. Originally approved in 1994. Last previous edition approved in 20082011
as F1537 – 08.F1537 – 11. DOI: 10.1520/F1537-11.10.1520/F1537-20.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s 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.
*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
1

---------------------- Page: 1 ----------------------
F1537 − 20
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot—the total number of mill products produced from the same melt heat under the same conditions at essentially the same
time.
4. Ordering Information
4.1 Inquiries and orders for material under this specification shall include the following information:
4.1.1 Quantity,Quantity;
4.1.2 ASTM designation, alloy number, and date of issue,issue;
4.1.3 Mechanical properties (See(see Section 7),);
4.1.4
...