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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
08/06/2013 Software/
Informatics		 13-55 Complete IEEE Std 11073-10421-2010 Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
12/23/2019 Materials 8-501 Complete ISO 5834-1 Fourth edition 2019-02 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
08/06/2013 Software/
Informatics		 13-56 Complete IEEE Std 11073-10406-2011 Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
08/21/2017 Software/
Informatics		 13-67 Complete ISO IEEE 11073-10418 First edition 2014-03-01 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)]
12/21/2020 Materials 8-542 Complete ASTM F138-19 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
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
07/06/2020 Anesthesiology 1-146 Complete ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
06/07/2021 Orthopedic 11-384 Complete ASTM F3446-20 Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
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