Standards

ASTM F2581 - 07


ASTM F2581 - 07 Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)


Active Standard ASTM F2581 Developed by Subcommittee: F04.12 |Book of Standards Volume: 13.02

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ASTM F2581

Abstract

This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 11manganese-17chromium-3molybdenum (UNS S29225) low-nickel stainless steel alloy bars and wires for surgical implants. The alloys shall be furnished in the annealed or cold-worked condition, and finished cold-drawn, pickled, ground, ground and polished, or as specified by the purchaser. Mechanical properties to which the alloys shall conform are ultimate tensile strength, yield strength, elongation, and reduction of area.

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. Scope

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 11manganese-17chromium-3molybdenum low-nickel stainless steel alloy bar and wire for surgical implants.

1.2 As of the time of the original approval of this specification no product utilizing this alloy had been approved through a 510(k) submission.

1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.


2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
E8 Test Methods for Tension Testing 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 Chromium - 13 Nickel - 5 Manganese - 2.5 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)

Aerospace Material Specification

AMS2248 Chemical Check Analysis Limits, Corrosion and Heat Resistant Steels and Alloys, Maraging and Other Highly-Alloyed Steels, and Iron Alloys

ISO Standard

ISO6892 Metallic Materials Tensile Testing at Ambient Temperature

American Society for Quality Standard

ASQC1 Specification of General Requirements for a Quality Program


Index Terms

low-nickel; manganese; metals (for surgical implants); nitrogen strengthened; stainless steel; surgical applications;



ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 77.140.20 (Steels of high quality)



DOI: 10.1520/F2581-07

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