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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Standard Designation
Number and Date

Title of Standard
12/21/2020 Materials 8-544 ASTM F961-20 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
12/21/2020 Materials 8-545 ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
12/21/2020 Materials 8-546 ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
12/21/2020 Materials 8-547 ASTM F629-20 Standard Practice for Radiography of Cast Metallic Surgical Implants
12/21/2020 Materials 8-548 ASTM ISO 52915 Third edition 2020-03 Specification for additive manufacturing file format (AMF) Version 1.2
12/21/2020 Materials 8-549 ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
12/21/2020 Materials 8-550 ASTM F2181-20 Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
12/21/2020 Materials 8-551 ASTM F2895-20 Standard Practice for Digital Radiography of Cast Metallic Implants
12/21/2020 Materials 8-552 ASTM F3434-20 Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing New publication
12/21/2020 Materials 8-553 ASTM ISO 52903-1 First edition 2020-04 Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials