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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.

Keywords

low-nickel; manganese; metals (for surgical implants); nitrogen strengthened; stainless steel; surgical applications; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 77.140.20 (Steels of high quality)

To find similar documents by ASTM Volume:

13.02 (Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

77.140.20 (Stainless steels Including alloyed steels, corrosion-resistant steels, heat-resisting steels, etc.)

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