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This specification covers the chemical, mechanical, and metallurgical requirements for wrought, nitrogen strengthened manganese-chromium-molybdenum low-nickel stainless steel alloy bars and wires used for surgical implants. All bars and wires should be furnished as specified in either annealed or cold-worked condition and in cold-drawn, pickled, ground and polished, ground, or any other specified finish. The products should conform to the required chemical composition, microcleanliness, purity, surface finish, tensile properties, and hardness and should pass the intergranular corrosion susceptibility test. Both wires and bars must have a homogenous microstructure and with grain sizes within the specified range.
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 chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 23manganese-21chromium-1molybdenum low-nickel stainless steel alloy bar and wire for 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 (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
A484/A484M Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
A555/A555M Specification for General Requirements for Stainless Steel Wire and Wire Rods
A751 Test Methods and Practices for Chemical Analysis of Steel Products
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
E45 Test Methods for Determining the Inclusion Content of Steel
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
E407 Practice for Microetching Metals and Alloys
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
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)
ISO StandardsISO 13485 Medical devicesQuality management systemsRequirements for regulatory purposes ISO6892 Metallic materialsTensile testingPart 1: Method of test at room temperature ISO9001
Aerospace Material SpecificationAMS2248 AMS 2630 AMS 2632
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 F2229-21, Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108), ASTM International, West Conshohocken, PA, 2021, www.astm.orgBack to Top