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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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07/06/2020 Materials 8-536 Complete ISO ASTM 52902:First Edition 2019-07 Additive Manufacturing -Test Artifacts - Geometric capability assessment of additive manufacturing systems
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
12/23/2019 Materials 8-519 Complete ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
07/15/2019 Materials 8-517 Complete ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements
07/15/2019 Materials 8-506 Complete ASTM F2516-18 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
12/23/2019 Materials 8-505 Complete ISO 6474-2 Second edition 2019-03 Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
01/14/2019 Materials 8-483 Complete ASTM F601-18 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
01/14/2019 Materials 8-482 Complete ASTM D1505-18 Standard Test Method for Density of Plastics by the Density-Gradient Technique
09/17/2018 Materials 8-479 Complete ISO 13781 Second edition 2017-07 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
09/17/2018 Materials 8-475 Complete ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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