ASTM F138-19

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

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STANDARD published on 1.12.2019

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The information about the standard:

Designation standards: ASTM F138-19
Publication date standards: 1.12.2019
SKU: NS-984146
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F138-19 :

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.

Keywords:

metals (for surgical implants), stainless steel, surgical applications wire, surgical implants,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

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 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

E10-23	Standard Test Method for Brinell Hardness of Metallic Materials
A262-15(2021)	Standard Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A751-21	Standard Test Methods and Practices for Chemical Analysis of Steel Products
E45-18a(2023)	Standard Test Methods for Determining the Inclusion Content of Steel (Includes all amendments and changes 11/6/2023).
E112-13(2021)	Standard Test Methods for Determining Average Grain Size
E354-21e1	Standard Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and Cobalt Alloys (Includes all amendments and changes 2/23/2022).
E407-23	Standard Practice for Microetching Metals and Alloys
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F1350-15	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
IEEE/ASTM SI 10	American National Standard for Metric Practice
AMS 2630	Inspection, Ultrasonic Product Over 0.5 inch (12.7 mm) Thick
AMS 2632	Ultrasonic Inspection of Thin Materials
A555/A555M-23	Standard Specification for General Requirements for Stainless Steel Wire and Wire Rods
A484/A484M-24	Standard Specification for General Requirements for Stainless Steel Bars, Billets, Shapes, and Forgings
E18-22	Standard Test Methods for Rockwell Hardness of Metallic Materials
E29-22	Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E8/E8M-24	Standard Test Methods for Tension Testing of Metallic Materials

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