ASTM F1537-11

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 inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

General Information

• Status: Historical
• Publication Date: 14-Nov-2011
• 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

• Replaces: ASTM F1537-08 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• Effective Date: 15-Nov-2011
• Replaced By: ASTM F1537-20 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• Effective Date: 01-Mar-2020
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 15-Nov-2011
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 15-Nov-2011
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 15-Nov-2011
• Referred By: ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
• Effective Date: 15-Nov-2011
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 15-Nov-2011
• 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: 15-Nov-2011
• Referred By: ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
• Effective Date: 15-Nov-2011
• Referred By: ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
• Effective Date: 15-Nov-2011
• Referred By: ASTM F1377-21 - Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
• Effective Date: 15-Nov-2011
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 15-Nov-2011
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 15-Nov-2011
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 15-Nov-2011
• Referred By: ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• Effective Date: 15-Nov-2011

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1537 −11
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.
3
1. Scope* 2.2 Aerospace Material Specifications:
AMS 2248 Chemical CheckAnalysis Limits, Corrosion and
1.1 This specification covers the chemical, mechanical, and
Heat Resistant Steels and Alloys, Maraging and Other
metallurgical requirements for three wrought cobalt-
Highly-Alloyed Steels, and Iron Alloys
28chromium-6molybdenum alloys used for surgical implants.
AMS 2269 Chemical CheckAnalysis Limits, Nickel, Nickel
The properties specified apply specifically to wrought bar, rod,
Alloys and Cobalt Alloys
and wire.
AMS 2630 Inspection, Ultrasonic Product over 0.5 Inch
1.2 The values stated in inch-pound units are to be regarded
(12.7 mm) Thick
as standard. The values given in parentheses are mathematical 4
2.3 ISO Standards:
conversions to SI units that are provided for information only
ISO 5832–12 Implants for Surgery—Metallic Materials—
and are not considered standard.
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-
3. Terminology
terials
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
4. Ordering Information
E354 Test Methods for Chemical Analysis of High-
Temperature,Electrical,Magnetic,andOtherSimilarIron, 4.1 Inquiries and orders for material under this specification
Nickel, and Cobalt Alloys
shall include the following information:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum 4.1.1 Quantity,
Alloy Castings and Casting Alloy for Surgical Implants
4.1.2 ASTM designation, alloy number, and date of issue,
(UNS R30075) 4.1.3 Mechanical properties (See Section 7),
F799 Specification for Cobalt-28Chromium-6Molybdenum
4.1.4 Form (bar, rod or wire),
Alloy Forgings for Surgical Implants (UNS R31537, 4.1.5 Applicable dimensions including size, thickness,
R31538, R31539)
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.
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devicesand is the direct responsibility of
5. Materials and Manufacture
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved Nov. 15, 2011. Published December 2011. Originally
5.1 Product shall be furnished as specified below:
approved in 1994. Last previous edition approved in 2008 as F1537 – 08. DOI:
10.1520/F1537-11.
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

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F1537−11
A,B
TABLE 2 Product Analysis Tolerances
5.1.1 The annealed condition is typically supplied as a hot
Element Permissible Variation Under the Minimum
rolled and annealed product.
Limit or Over the Maximum Limit, % (mass/
5.1.2 Thehotworkedconditionistypicallysuppliedasahot
C
mass)
rolled and unannealed product.
Carbon 0.02
Aluminum# 0.50 0.05
5.1.3 The warm worked condition is typically supplied as a
Aluminum>0.50upto1.00 0.10
thermomechanically processed product to achieve a strain-
Lanthanum 0.01
hardened structure.
Chromium 0.30
Molybdenum 0.15
Nickel 0.05
6. Chemical Requirements
Iron 0.03
Silicon 0.05
6.1 Thecobalt-28chromium-6molybdenumalloysshallcon-
Manganese 0.03
form to the
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1537–08 Designation: F1537 – 11
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 inch-pound units are to be regarded as standard. The values given in parentheses are mathematical
conversions to SI units that are provided for information only and are not considered standard.
2. Referenced Documents
2
2.1 ASTM Standards:
E88/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-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
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 Ultrasonic Inspection 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
2.4 American Society for Quality Standard:
ASQC1Specification of General Requirements for a Quality Program
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 lot—thetotalnumberofmillproductsproducedfromthesamemeltheatunderthesameconditionsatessentiallythesame
time.
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 Oct. 1, 2008. Published October 2008. Originally approved in 1994. Last previous edition approved in 2007 as F1537–07. DOI:
10.1520/F1537-08.
Current edition approved Nov. 15, 2011. Published December 2011. Originally approved in 1994. Last previous edition approved in 2008 as F1537 – 08. DOI:
10.1520/F1537-11.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 – 11
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.
5.1.2 The hot worke
...