ASTM F75-23

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

ABSTRACT
This specification covers the requirements for unfinished cobalt-28chromium-6molybdenum (UNS R30075) investment product alloy castings for surgical implant applications, and casting alloys of the same in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings. Both product castings and casting alloys shall conform to specified chemical composition and mechanical requirements including ultimate tensile strength, yield strength, elongation, and reduction of area. Product castings shall additional undergo liquid penetrant, radiographic, metallographic, and hardness examination.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for cobalt-28 chromium-6 molybdenum alloy unfinished investment product castings for surgical implant applications and casting alloy in the form of shot, bar, or ingots to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from castings.  
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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: 30-Apr-2023
• 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

• Refers: ASTM F629-20 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 01-Feb-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: F75 − 23
Standard Specification for
Cobalt-28 Chromium-6 Molybdenum Alloy Castings and
1
Casting Alloy for Surgical Implants (UNS R30075)
This standard is issued under the fixed designation F75; 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* E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials
1.1 This specification covers the chemical, mechanical, and
E18 Test Methods for Rockwell Hardness of Metallic Ma-
metallurgical requirements for cobalt-28 chromium-6 molyb-
terials
denum alloy unfinished investment product castings for surgi-
E29 Practice for Using Significant Digits in Test Data to
cal implant applications and casting alloy in the form of shot,
Determine Conformance with Specifications
bar, or ingots to be used in the manufacture of surgical
E165/E165M Practice for Liquid Penetrant Testing for Gen-
implants. This specification does not apply to completed
eral Industry
surgical implants made from castings.
E354 Test Methods for Chemical Analysis of High-
1.2 The values stated in either SI units or inch-pound units
Temperature, Electrical, Magnetic, and Other Similar Iron,
are to be regarded separately as standard. The values stated in
Nickel, and Cobalt Alloys
each system may not be exact equivalents; therefore, each
E407 Practice for Microetching Metals and Alloys
system shall be used independently of the other. Combining
F601 Practice for Fluorescent Penetrant Inspection of Me-
values from the two systems may result in nonconformance
tallic Surgical Implants
with the standard.
F629 Practice for Radiography of Cast Metallic Surgical
1.3 This standard does not purport to address all of the Implants
safety concerns, if any, associated with its use. It is the
F981 Practice for Assessment of Compatibility of Biomate-
responsibility of the user of this standard to establish appro- rials for Surgical Implants with Respect to Effect of
priate safety, health, and environmental practices and deter-
Materials on Muscle and Insertion into Bone
mine the applicability of regulatory limitations prior to use. IEEE/ASTM SI 10 American National Standard for Metric
1.4 This international standard was developed in accor-
Practice
3
dance with internationally recognized principles on standard-
2.2 Aerospace Material Specification:
ization established in the Decision on Principles for the
AMS 2248 Chemical Check Analysis Limits: Corrosion and
Development of International Standards, Guides and Recom-
Heat Resistant Steels and Alloys, Maraging and Other
mendations issued by the World Trade Organization Technical
Highly-Alloyed Steels, and Iron Alloys
Barriers to Trade (TBT) Committee.
AMS 2269 Chemical Check Analysis Limits: Nickel, Nickel
Alloys and Cobalt Alloys
4
2. Referenced Documents
2.3 ISO Standards:
2
ISO 5832-4 Implants for Surgery—Metallic Materials—Part
2.1 ASTM Standards:
4: Cobalt-Chromium-Molybdenum Casting Alloy
A957/A957M Specification for Investment Castings, Steel
ISO 6892 Metallic Materials—Tensile Testing at Ambient
and Alloy, Common Requirements, for General Industrial
Temperature
Use
ISO 9001 Quality Management Systems—Requirements
E3 Guide for Preparation of Metallographic Specimens
ISO 13485 Medical Devices—Quality Management
Systems—Requirements for Regulatory Purposes
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
3. Terminology
Subcommittee F04.12 on Metallurgical Materials.
3.1 Definitions of Terms Specific to This Standard:
Current edition approved May 1, 2023. Published May 2023. Originally
approved in 1967. Last previous edition approved in 2018 as F75 – 18. DOI:
10.1520/F0075-23.
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 from American 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 ---------------
...

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: F75 − 18 F75 − 23
Standard Specification for
Cobalt-28 Chromium-6 Molybdenum Alloy Castings and
1
Casting Alloy for Surgical Implants (UNS R30075)
This standard is issued under the fixed designation F75; 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 cobalt-28 chromium-6 molybdenum
alloy unfinished investment product castings for surgical implant applications and casting alloy in the form of shot, bar, or ingots
to be used in the manufacture of surgical implants. This specification does not apply to completed surgical implants made from
castings.
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 may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformancenonconformance with the standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.4 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:
A957A957/A957M Specification for Investment Castings, Steel and Alloy, Common Requirements, for General Industrial Use
E3 Guide for Preparation of Metallographic Specimens
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
E165E165/E165M Practice for Liquid Penetrant Testing for General Industry
E354 Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and
Cobalt Alloys
E407 Practice for Microetching Metals and Alloys
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F629 Practice for Radiography of Cast Metallic Surgical Implants
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, 2018May 1, 2023. Published January 2019May 2023. Originally approved in 1967. Last previous edition approved in 20122018 as
F75 – 12.F75 – 18. DOI: 10.1520/F0075-18.10.1520/F0075-23.
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.
*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 ----------------------
F75 − 23
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
IEEE/ASTM SI 10 American National Standard for Metric Practice
3
2.2 Aerospace Material Specification:
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
4
2.3 ISO Standards:
ISO 5832-4 Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy
ISO 6892 Metallic Materials—Tensile Testing at Ambient Temperature
ISO 9001 Quality Management Systems—Requirements
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 investment casting, n—a metal casting that is pr
...