ASTM F961-20

Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

ABSTRACT
This specification covers the chemical composition and mechanical requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) forgings for use in surgical implants. The material covered here shall be in the form of bars, plates, sheets, or wires manufactured in the solution-annealed condition with a finish suitable for forging by hammering, pressing, rolling, extruding, or upsetting.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of forgings, used for the manufacture of surgical implants.  
1.2 Units—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 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: 31-Jan-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

• Refers: ASTM A484/A484M-20a - Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
• Effective Date: 05-May-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: F961 −20
Standard Specification for
35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Forgings for Surgical Implants (UNS R30035)
ThisstandardisissuedunderthefixeddesignationF961;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* E10 Test Method for Brinell Hardness of Metallic Materials
E18 Test Methods for Rockwell Hardness of Metallic Ma-
1.1 This specification covers the chemical, mechanical, and
terials
metallurgical requirements for 35cobalt-35nickel-
E29 Practice for Using Significant Digits in Test Data to
20chromium-10molybdenum alloy (UNS R30035) in the form
Determine Conformance with Specifications
of forgings, used for the manufacture of surgical implants.
E92 Test Methods for Vickers Hardness and Knoop Hard-
1.2 Units—The values stated in either SI units or inch-
ness of Metallic Materials
pound units are to be regarded separately as standard. The
E112 Test Methods for Determining Average Grain Size
values stated in each system are not necessarily exact equiva-
E140 Hardness Conversion Tables for Metals Relationship
lents; therefore, to ensure conformance with the standard, each
Among Brinell Hardness, Vickers Hardness, Rockwell
system shall be used independently of the other, and values
Hardness, Superficial Hardness, Knoop Hardness, Sclero-
from the two systems shall not be combined.
scope Hardness, and Leeb Hardness
1.3 This standard does not purport to address all of the
E165 Practice for Liquid Penetrant Testing for General
safety concerns, if any, associated with its use. It is the Industry
responsibility of the user of this standard to establish appro-
E354 Test Methods for Chemical Analysis of High-
priate safety, health, and environmental practices and deter- Temperature,Electrical,Magnetic,andOtherSimilarIron,
mine the applicability of regulatory limitations prior to use.
Nickel, and Cobalt Alloys
1.4 This international standard was developed in accor- F562 Specification for Wrought 35Cobalt-35Nickel-
dance with internationally recognized principles on standard-
20Chromium-10Molybdenum Alloy for Surgical Implant
ization established in the Decision on Principles for the Applications (UNS R30035)
Development of International Standards, Guides and Recom-
F601 Practice for Fluorescent Penetrant Inspection of Me-
mendations issued by the World Trade Organization Technical
tallic Surgical Implants
Barriers to Trade (TBT) Committee. F688 Specification for Wrought Cobalt-35Nickel-
20Chromium-10MolybdenumAlloy Plate, Sheet, and Foil
2. Referenced Documents
for Surgical Implants (UNS R30035)
2
2.1 ASTM Standards:
IEEE/ASTM SI 10 American National Standard for Use of
A484/A484M Specification for General Requirements for
theInternationalSystemofUnits(SI):TheModernMetric
Stainless Steel Bars, Billets, and Forgings
System
3
A555/A555M Specification for General Requirements for
2.2 ISO Standards:
Stainless Steel Wire and Wire Rods
ISO 5832-6 Implants for Surgery–Metallic Materials–Part 6:
A751 Test Methods, Practices, and Terminology for Chemi-
Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy
cal Analysis of Steel Products
ISO 9001 Quality Management Systems—Requirements
E8/E8M Test Methods for Tension Testing of Metallic Ma-
ISO 13485 Medical Devices—Quality Management
terials
Systems—Requirements for Regulatory Purposes
3. Terminology
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
3.1 Definitions of Terms Specific to This Standard:
Subcommittee F04.12 on Metallurgical Materials
3.1.1 lot, n—the total number of forgings produced from the
Current edition approved Feb. 1, 2020. Published April 2020. Originally
approved in 1985. Last previous edition approved in 2014 as F961 – 14. DOI: same heat under the same conditions at essentially the same
10.1520/F0961-20.
time.
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
3
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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...

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: F961 − 14 F961 − 20
Standard Specification for
35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy
1
Forgings for Surgical Implants (UNS R30035)
This standard is issued under the fixed designation F961; 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 35cobalt-35nickel-20chromium-
10molybdenum alloy (UNS R30035) in the form of forgings, used for the manufacture of surgical implants.
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated
in each system mayare not benecessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall
be used independently of the other. Combiningother, and values from the two systems may result in nonconformance with the
standard.shall not be combined.
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:
A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods
A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
E8/E8M Test Methods for Tension Testing of Metallic Materials
E10 Test Method for Brinell Hardness 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
E92 Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E112 Test Methods for Determining Average Grain Size
E140 Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness,
Superficial Hardness, Knoop Hardness, Scleroscope Hardness, and Leeb Hardness
E165 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
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F688 Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical
Implants (UNS R30035)
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, 2014Feb. 1, 2020. Published November 2014April 2020. Originally approved in 1985. Last previous edition approved in 20082014 as
F961 – 08.F961 – 14. DOI: 10.1520/F0961-14.10.1520/F0961-20.
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.
*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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F961 − 20
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 Use of the International System of Units (SI): The Modern Metric System
3
2.2 ISO Standards:
ISO 5832-6 Implants for Surgery–Metallic Materials–Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum All
...