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This specification covers the requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants. Bar and wire shall be furnished, as specified, in the hot-worked, annealed, cold -worked, or extra hard condition. Fine wire shall be furnished, as specified, in the cold-drawn condition. Types of finish available for bar and wire products are cold-drawn, pickled, ground, and ground and polished. On the other hand, types of finish available for fine wire products are cold-drawn, ground, and ground and polished. The heat analysis shall conform to the requirements as to chemical composition specified and the material shall contain no delta ferrite, chi, or sigma phases when it is examined by metallography. Different tests shall be performed in order to determine the following mechanical properties of the wire and bar: ultimate tensile strength, yield strength, elongation, and Brinell hardness.
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 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants.
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 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.
Aerospace Material StandardAMS 2630 Inspection, Ultrasonic Product Over 0.5 inch (12.7 mm) Thick AMS 2632 Ultrasonic Inspection of Thin Materials
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, Practices, and Terminology 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
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
F1350 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
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 F138-19, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673), ASTM International, West Conshohocken, PA, 2019, www.astm.orgBack to Top