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

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

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

Keywords

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

ASTM International is a member of CrossRef.