【国外标准】 Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)

This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for coating of orthopedic implants. This specification covers powder requirements only and does not address coating properties. Materials may be manufactured by rotating electrode process, inert gas atomization, or other methods that meet the powder requirements of this specification. The powder shall conform to chemical composition, sieve analysis, and cleanliness requirements of this specification.1.1 This specification covers the requirements for cobalt-28chromium-6molybdenum alloy powders for use in fabricating cobalt-28chromium-6molybdenum alloy medical devices.1.2 Powders covered under this specification may be used to form coatings by sintering or thermal spraying techniques, or in metal injection molding or additive manufacturing.1.3 This specification covers powder requirements only. It does not address properties of the coatings or components formed from them.1.4 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.1.5 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.1.6 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.