ASTM F1537-08

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: 30-Sep-2008
• 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 F1537-07 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• Effective Date: 01-Oct-2008
• Replaced By: ASTM F1537-11 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• Effective Date: 15-Nov-2011
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Oct-2008
• Referred By: ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
• Effective Date: 01-Oct-2008
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Oct-2008
• Referred By: ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
• Effective Date: 01-Oct-2008
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 01-Oct-2008
• Referred By: ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
• Effective Date: 01-Oct-2008
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 01-Oct-2008
• Referred By: ASTM F2886-17(2023) - Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications
• Effective Date: 01-Oct-2008
• Referred By: ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• Effective Date: 01-Oct-2008
• Referred By: ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
• Effective Date: 01-Oct-2008
• 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-Oct-2008
• Referred By: ASTM F2527-16 - Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
• Effective Date: 01-Oct-2008
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Oct-2008

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 – 08
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* and Heat Resistant Steels andAlloys, Maraging and Other
Highly-Alloyed Steels, and Iron Alloys
1.1 This specification covers the chemical, mechanical, and
AMS 2269 Chemical Check Analysis Limits, Nickel,
metallurgical requirements for three wrought cobalt-
Nickel Alloys and Cobalt Alloys
28chromium-6molybdenum alloys used for surgical implants.
AMS 2630 Ultrasonic Inspection
The properties specified apply specifically to wrought bar, rod,
4
2.3 ISO Standards:
and wire.
ISO 5832–12 Implants for Surgery—Metallic Materials—
1.2 The values stated in inch-pound units are to be regarded
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy
as standard. The values given in parentheses are mathematical
ISO 6892 Metallic Materials Tensile Testing at Ambient
conversions to SI units that are provided for information only
Temperature
and are not considered standard.
ISO 9001 Quality Management Systems—Requirements
5
2. Referenced Documents 2.4 American Society for Quality Standard:
2
ASQ C1 Specification of General Requirements for a Qual-
2.1 ASTM Standards:
ity Program
E8 Test Methods for Tension Testing of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Ma-
3. Terminology
terials
3.1 Definitions of Terms Specific to This Standard:
E29 Practice for Using Significant Digits in Test Data to
3.1.1 lot—the total number of mill products produced from
Determine Conformance with Specifications
the same melt heat under the same conditions at essentially the
E112 Test Methods for Determining Average Grain Size
same time.
E354 Test Methods for Chemical Analysis of High-
Temperature, Electrical, Magnetic, and Other Similar Iron,
4. Ordering Information
Nickel, and Cobalt Alloys
4.1 Inquiries and orders for material under this specification
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
shall include the following information:
Alloy Castings and Casting Alloy for Surgical Implants
4.1.1 Quantity,
(UNS R30075)
4.1.2 ASTM designation, alloy number, and date of issue,
F799 Specification for Cobalt-28Chromium-6Molybdenum
4.1.3 Mechanical properties (See Section 7),
Alloy Forgings for Surgical Implants (UNS R31537,
4.1.4 Form (bar, rod or wire),
R31538, R31539)
3 4.1.5 Applicable dimensions including size, thickness,
2.2 Aerospace Material Specifications:
width, and length (exact, random, or multiples) or drawing
AMS 2248 Chemical Check Analysis Limits, Corrosion
number,
4.1.6 Condition (See Section 5),
4.1.7 Special tests (if any), and
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.8 Other requirements.
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials.
5. Materials and Manufacture
Current edition approved Oct. 1, 2008. Published October 2008. Originally
approved in 1994. Last previous edition approved in 2007 as F1537 – 07. DOI:
5.1 Product shall be furnished as specified below:
10.1520/F1537-08.
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
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.
3 5
Available from Society of Automotive Engineers (SAE), 400 Commonwealth Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Dr., Warrendale, PA 15096-0001, http://www.sae.org. Milwaukee, WI 53203, http://www.asq.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 – 08
A,B
TABLE 2 Product Analysis Tolerances
5.1.1 The annealed condition is typically supplied as a hot
rolled and annealed product. Element Permissible Variation Under the Minimum
Limit or Over the Maximum Limit, % (mass/
5.1.2 Thehotworkedconditionistypicallysuppliedasahot
C
mass)
rolled and unannealed product.
Carbon 0.02
5.1.3 The warm worked condition is typically supplied as a
Aluminum# 0.50 0.05
thermomechanically processed product to achieve a strain-
Aluminum>0.50upto1.00 0.10
Lantha
...

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:F1537–07 Designation: F 1537 – 08
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 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 (´) 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.
1.2Thevaluesstatedininch-poundunitsaretoberegardedasthestandard.TheSIequivalentsinparenthesesareforinformation
only.
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:
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 High-Temperature, 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)
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
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
5
2.4 American Society for Quality Standard:
ASQ C1 Specification of General Requirements for a Quality Program
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
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 JulyOct. 1, 2007.2008. Published August 2007.October 2008. Originally approved in 1994. Last previous edition approved in 20002007 as
F 1537 – 007.
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.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F1537–08
3.1.1 lot—thetotalnumberofmillproductsproducedfromthesamemeltheatunderthesameconditionsatessentiallythesame
time.
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.
...