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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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06/07/2021 Orthopedic 11-379 Complete ASTM F2978-20 Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
06/07/2021 Orthopedic 11-380 Complete ASTM F2979-20 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
06/07/2021 Radiology 12-339 Complete IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
04/04/2016 ObGyn/
Gastroenterology/
Urology		 9-113 Complete CEN EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
07/06/2020 Biocompatibility 2-275 Complete ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
06/07/2021 General Plastic Surgery/
General Hospital		 6-462 Complete IEC 60601-2-20 Edition 3.0 2020-09 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
07/15/2019 Sterility 14-532 Complete ASTM F3287-17e1 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method
12/21/2020 Biocompatibility 2-283 Complete ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices
06/07/2021 Anesthesiology 1-151 Complete ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
06/07/2021 Materials 8-558 Complete ASTM F3333-20 Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
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