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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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12/20/2021 Materials 8-570 Complete ASTM F1108-21 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
12/20/2021 Materials 8-569 Complete ASTM F648-21 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
12/20/2021 Materials 8-568 Complete ASTM F1586-21 Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675)
12/20/2021 Materials 8-567 Complete ASTM F86-21 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
12/20/2021 Materials 8-566 Complete ASTM F1813-21 Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120)
06/07/2021 Materials 8-561 Complete ASTM ISO 52950 First edition 2021-01 Additive manufacturing - General principles - Overview of data processing
06/07/2021 Materials 8-556 Complete ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
12/21/2020 Materials 8-546 Complete ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
12/21/2020 Materials 8-545 Complete ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
07/06/2020 Materials 8-528 Complete ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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