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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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05/29/2023 Physical Medicine 16-234 Complete ISO 7176-14 Third Edition 2022 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
01/30/2014 Physical Medicine 16-25 Complete ISO 7176-13 First edition 1989-08-01 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
08/06/2013 Physical Medicine 16-190 Complete ISO 7176-11 Second edition 2012-12-01 Wheelchairs - Part 11: Test dummies
01/30/2014 Physical Medicine 16-164 Complete ISO 7176-10 Second edition 2008-11-01 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
04/04/2016 Physical Medicine 16-195 Complete ISO 7176-1 Third edition 2014-10-01 Wheelchairs - Part 1: Determination of static stability
12/19/2022 Physical Medicine 16-233 Complete ISO 16840-10 Second edition 2021-06 Corrected version 2022-01 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
03/18/2009 InVitro Diagnostics 7-180 Complete CLSI M34-A (Replaces M24-P) Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
09/17/2018 Orthopedic 11-336 Complete ISO 17853 Third edition 2011-03-01 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization
12/18/2023 Sterility 14-597 Complete AAMI ANSI ST108:2023 Water for the processing of medical devices
03/18/2009 InVitro Diagnostics 7-185 Complete CLSI M41-A Viral Culture; Approved Guideline.
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