ASTM F621-12(2021)e1

Standard Specification for Stainless Steel Forgings for Surgical Implants (Includes all amendments and changes 8/19/2021).

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STANDARD published on 1.5.2017

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The information about the standard:

Designation standards: ASTM F621-12(2021)e1
Publication date standards: 1.5.2017
SKU: NS-1033038
The number of pages: 4
Approximate weight : 12 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F621-12(2021)e1 :

This specification covers the requirements for stainless steel forgings for surgical implants. Materials for forgings shall be bars or wire and shall be forged by hammering, pressing, rolling, extruding, or upsetting. The material shall comply with the manufacturing procedure, chemical composition, mechanical requirements, and test methods indicated in this specification. Mechanical testing includes tension, tensile, elongation, and hardness tests. Special tests shall also be done such as corrosion tests, grain size, and fluorescent penetrant inspection.

Keywords:

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

Additional information

1. Scope

1.1 This specification covers the requirements of forged stainless steel for surgical implants when the material forged conforms to Specifications F138 (UNS S31673), F1314 (UNS S21910), F1586 (UNS S31675), F2229 (UNS S29108), or F2581 (UNS R56320).

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 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

E18-22	Standard Test Methods for Rockwell Hardness of Metallic Materials
A262-15(2021)	Standard Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
F1586-21	Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
A473-23a	Standard Specification for Stainless Steel Forgings (Includes all amendments and changes 9/21/2023).
E8-04	Standard Test Methods for Tension Testing of Metallic Materials
E10-23	Standard Test Method for Brinell Hardness of Metallic Materials
E29-22	Standard Practice for Using Significant Digits in Test Data to Determine Conformance with Specifications
E92-23	Standard Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E112-13(2021)	Standard Test Methods for Determining Average Grain Size
E165-09	Standard Practice for Liquid Penetrant Examination for General Industry
E353-19e1	Standard Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys (Includes all amendments and changes 2/23/2022).
F138-19	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F1314-18	Standard 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)
F2229-21	Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)
F2581-12(2017)	Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
IEEE/ASTM SI 10	American National Standard for Metric Practice
ISO 9001	Quality Managements Systems--Requirements
F601-23	Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

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