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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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04/04/2016 Materials 8-413 Complete ASTM F2819-10 (Reapproved 2015) Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
12/21/2020 Biocompatibility 2-288 Partial ISO 10993-15 Second edition 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
12/20/2021 General Plastic Surgery/
General Hospital		 6-467 Complete USP-NF M80200_04_01 Nonabsorbable Surgical Suture
12/20/2021 General Plastic Surgery/
General Hospital		 6-468 Complete USP-NF M99670_02_01 <881> Tensile Strength
12/20/2021 General Plastic Surgery/
General Hospital		 6-469 Complete USP-NF M99650_02_01 <861> Sutures - Diameter
12/20/2021 General Plastic Surgery/
General Hospital		 6-470 Complete USP-NF M99660_03_01 <871> Sutures - Needle Attachment
12/20/2021 Materials 8-565 Complete ASTM F2754/F2754M-21 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire
05/29/2023 Materials 8-601 Complete ASTM F2516-22 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials
12/18/2023 Materials 8-607 Complete ASTM F2082/F2082M-23 Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
12/23/2024 Materials 8-622 Complete ASTM F2004-24 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
12/23/2024 Materials 8-624 Complete ASTM F2129-24 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
12/23/2024 Materials 8-626 Complete ASTM E2948-24 Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire
05/29/2023 Cardiovascular 3-184 Complete ASTM F2477-23 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
05/26/2025 Cardiovascular 3-200 Complete ASTM F2477-24 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
 
 
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