ASTM F961-20 - 1.2.2020
 
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 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.

 
2. Referenced Documents

IEEE/ASTM SI 10

American National Standard for Use of the International System of Units (SI): The Modern Metric System

A751-21

Standard Test Methods and Practices for Chemical Analysis of Steel Products

E112-13(2021)

Standard Test Methods for Determining Average Grain Size

E92-23

Standard Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials

E29-22

Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications

E18-22

Standard Test Methods for Rockwell Hardness of Metallic Materials

E10-23

Standard Test Method for Brinell Hardness of Metallic Materials

E8/E8M-24

Standard Test Methods for Tension Testing of Metallic Materials

F601-23

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

F562-22

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

E354-21e1

Standard Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and Cobalt Alloys (Includes all amendments and changes 2/23/2022).

E165-09

Standard Practice for Liquid Penetrant Examination for General Industry

E140-12B(2019)e1

Standard Hardness Conversion Tables for Metals Relationship Among Brinell Hardness, Vickers Hardness, Rockwell Hardness, Superficial Hardness, Knoop Hardness, Scleroscope Hardness, and Leeb Hardness (Includes all amendments and changes 5/7/2019).

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

F688-19

Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

ASQ C1

Specification of General Requirements for a Quality Program

ISO 9001

Quality Management Systems--Requirements

ISO 5832-6

Implants for Surgery-Metallic Materials-Part 6: Wrought Cobalt-Nickel-Chromium-Molybdenum Alloy