ASTM F562-22

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

ABSTRACT
This specification covers requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work-strengthening, and work-strengthening and aging to attain a variety of combinations of strength and ductility. Materials shall be tested and the individual grades shall conform to chemical requirements such as chemical composition and their tolerances, and mechanical properties such as tensile strength, yield strength, elongation, and area reduction.
SCOPE
1.1 This specification covers requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work strengthening and aging to attain a variety of combinations of strength and ductility.  
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, 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-Dec-2021
• 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

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:F562 −22
Standard Specification for
Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum
1
Alloy for Surgical Implant Applications (UNS R30035)
ThisstandardisissuedunderthefixeddesignationF562;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* Determine Conformance with Specifications
E112 Test Methods for Determining Average Grain Size
1.1 This specification covers requirements of wrought
E354 Test Methods for Chemical Analysis of High-
35cobalt-35nickel-20chromium-10molybdenum alloy (UNS
Temperature,Electrical,Magnetic,andOtherSimilarIron,
R30035) in the form of bar and wire, used for the manufacture
Nickel, and Cobalt Alloys
of surgical implants. This alloy depends on combinations of
F981 Practice for Assessment of Compatibility of Biomate-
work strengthening and aging to attain a variety of combina-
rials for Surgical Implants with Respect to Effect of
tions of strength and ductility.
Materials on Muscle and Insertion into Bone
1.2 The values stated in either SI units or inch-pound units
IEEE/ASTM SI 10 American National Standard for Metric
are to be regarded separately as standard. The values stated in
Practice
each system may not be exact equivalents; therefore, to ensure
3
2.2 ISO Standards:
conformance with the standard, each system shall be used
ISO 5832/6 Implants for Surgery—Metallic Materials Part
independently of the other and values from the two systems
6: Wrought cobalt-nickel-chromium-molybdenum Alloy
shall not be combined.
ISO 6892 Metallic Materials—Tensile Testing at Ambient
1.3 This standard does not purport to address all of the
Temperature
safety concerns, if any, associated with its use. It is the
ISO 9001 Quality Management Systems
responsibility of the user of this standard to establish appro-
ISO 13485 Medical Devices—Quality Management
priate safety, health, and environmental practices and deter-
Systems—Requirements for Regulatory Purposes
mine the applicability of regulatory limitations prior to use.
4
2.3 Aerospace Material Specifications:
1.4 This international standard was developed in accor-
AMS 2269 Chemical Check Analysis Limits—Wrought
dance with internationally recognized principles on standard-
Nickel Alloys and Cobalt Alloys
ization established in the Decision on Principles for the
AMS 2630 Inspection, Ultrasonic Product over 0.5 inch
Development of International Standards, Guides and Recom-
(12.7 mm) Thick
mendations issued by the World Trade Organization Technical
AMS 2632 Ultrasonic Inspection of Thin Materials
Barriers to Trade (TBT) Committee.
3. Terminology
2. Referenced Documents
2
3.1 Definitions of Terms Specific to This Standard:
2.1 ASTM Standards:
3.1.1 bar, n—round, rectangular, or other complex-shaped
A751 Test Methods and Practices for Chemical Analysis of
product delivered straightened and cut to defined lengths.
Steel Products
E8/E8M Test Methods for Tension Testing of Metallic Ma- 3.1.2 fine wire, n—round, rectangular, or other complex
terials shapesofuniformcrosssectionalongitswholelengthlessthan
E29 Practice for Using Significant Digits in Test Data to 1.60 mm [0.063 in.] in diameter or thickness furnished in coils,
or on spools, reels, or other packaging as specified.
3.1.3 forging bar, n—bar as described in 3.1.1, used for the
1
This specification is under the jurisdiction of ASTM Committee F04 on
production of forgings; may be furnished in the hot-worked
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.12 on Metallurgical Materials. condition.
Current edition approved Jan. 1, 2022. Published January 2022. Originally
approved in 1978. Last previous edition approved in 2013 as F562 – 13. DOI:
10.1520/F0562-22.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
4
Standards volume information, refer to the standard’s Document Summary page on Available from Society of Automotive Engineers, Inc., 400 Commonwealth
the ASTM website. Drive, Warrendale, PA 15096–0001.
*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 ----------------------
F562−22
3.1.4 lot, n—the total nu
...

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: F562 − 13 F562 − 22
Standard Specification for
Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum
1
Alloy for Surgical Implant Applications (UNS R30035)
This standard is issued under the fixed designation F562; 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 requirements of wrought 35cobalt-35nickel-20chromium-10molybdenum alloy (UNS R30035) in the
form of bar and wire, used for the manufacture of surgical implants. This alloy depends on combinations of work strengthening
and aging to attain a variety of combinations of strength and ductility.
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 aremay not necessarilybe exact equivalents; therefore, to ensure conformance with the standard, each system shall be used
independently of the other,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.
2. Referenced Documents
2
2.1 ASTM Standards:
A751 Test Methods and Practices for Chemical Analysis of Steel Products
E8/E8M Test Methods for Tension Testing 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
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 ISO Standards:
ISO 5832/6 Implants for Surgery—Metallic Materials Part 6: Wrought cobalt-nickel-chromium-molybdenum Alloy
ISO 6892 Metallic Materials—Tensile Testing at Ambient Temperature
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 March 1, 2013Jan. 1, 2022. Published March 2013January 2022. Originally approved in 1978. Last previous edition approved in 20072013 as
F562 – 07.F562 – 13. DOI: 10.1520/F0562-13.10.1520/F0562-22.
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 Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
*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 ----------------------
F562 − 22
ISO 9001 Quality Management Systems
ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
4
2.3 Aerospace Material Specifications:
AMS 2269 Chemical Check Analysis Limits—Wrought Nickel Alloys and Cobalt Alloys
AMS 2630 Inspection, Ultrasonic Product over 0.5 inch (12.7 mm) Thick
AMS 2632 Ultrasonic Inspection of Thin Materials
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 bar, n—rounds, flats, or other shapes from 0.1875 to 4.00 in. [4.76 to 101.60 mm] in diameter or thickness (other sizes and
shapes by special order).round, rectangular, or other complex-shaped product delivered straightened and cut to defined lengths.
3.1.2 fine wire, n—rounds, flats,round, rectangular, or other shapes less than 0.063 in. [1.60 mm] complex shapes of uni
...