ASTM F138

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. Scope

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 inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

2. Referenced Documents

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
E10 Test Method for Brinell Hardness of Metallic Materials
E112 Test Methods for Determining Average Grain Size
E18 Test Methods for Rockwell Hardness of Metallic Materials
E29 Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
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
E45 Test Methods for Determining the Inclusion Content of Steel
E8 Test Methods for Tension Testing of Metallic Materials
E8M Test Methods for Tension Testing of Metallic Materials [Metric]
F1350 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
ASQ Standard
ASQC1 Specification of General Requirements for a Quality Program
ISO Standards
ISO9001 Quality Management Systems--Requirements

Index Terms

metals (for surgical implants); stainless steel; surgical applications wire; surgical implants; Chromium surgical implant applications--specifications; Orthopaedic medical devices--specifications; Stainless steel surgical applications--specifications; Surgical implants--specifications; UNS S31673 (Cr-Ni-Mo stainless steel (Surgical implant 316L)); Wire--surgical implants; Wrought chromium surgical implant alloys; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Citing ASTM Standards

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