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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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 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 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A473 Specification for Stainless Steel Forgings
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
E165 Practice for Liquid Penetrant Testing for General Industry
E353 Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F1314 Specification for Wrought Nitrogen Strengthened 22 Chromium13 Nickel5 Manganese2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
F1586 Specification for Wrought Nitrogen Strengthened 21Chromium--10Nickel--3Manganese--2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
F2229 Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
F2581 Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
ISO StandardsISO 5832-1 Implants for SurgeryMetallic Materials Part 1: Wrought Stainless Steel ISO 9001 Quality Managements SystemsRequirements
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)
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ASTM F621-12(2021)e1, Standard Specification for Stainless Steel Forgings for Surgical Implants, ASTM International, West Conshohocken, PA, 2017, www.astm.orgBack to Top