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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/21/2020 Ophthalmic 10-120 Complete ISO TR 22979 Second Edition 2017-05 Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-132 Complete ASTM F623-19 Standard Performance Specification for Foley Catheter
06/07/2021 Cardiovascular 3-170 Complete ISO 14708-5 Second edition 2020-05 Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
12/21/2020 Materials 8-545 Complete ASTM F2977-20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
12/21/2020 InVitro Diagnostics 7-300 Complete CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
12/21/2020 InVitro Diagnostics 7-301 Complete CLSI GP42 7th Edition Collection of Capillary Blood Specimens
06/07/2021 ObGyn/
Gastroenterology/
Urology		 9-135 Complete ISO 23500-3 First edition 2019-02 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
ANSI AAMI ISO 23500-3:2019 Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies
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
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