ASTM-F621 › Standard Specification for Stainless Steel Forgings for Surgical Implants
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This specification covers the requirements for stainless steel forgings for surgical implants. Materials for forgings shall be bars or wire and shall be forged by hammering, pressing, rolling, extruding, or upsetting. The material shall comply with the manufacturing procedure, chemical composition, mechanical requirements, and test methods indicated in this specification. Mechanical testing includes tension, tensile, elongation, and hardness tests. Special tests shall also be done such as corrosion tests, grain size, and fluorescent penetrant inspection.
1.1 This specification covers the requirements of forged stainless steel for surgical implants when the material forged conforms to Specifications (UNS S31673), (UNS S21910), (UNS S31675), (UNS S29108), or (UNS R56320).
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-conformance with the standard.
1.3 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.
forgings—surgical implants; metals (for surgical implants)—stainless steel; stainless steel—surgical applications ;; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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2012 R17 EDITION
July 1, 2017