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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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06/07/2018 Neurology 17-1 Partial AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices
05/29/2023 Physical Medicine 16-236 Complete ISO 7176-19 Third Edition 2022 Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles
05/29/2023 Physical Medicine 16-235 Complete ISO 7176-25 Second Edition 2022 Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods
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
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
12/23/2019 Physical Medicine 16-219 Complete RESNA ANSI WC-2:2019 Section 14 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods
01/14/2019 Physical Medicine 16-204 Complete ISO 7176-6 Third edition 2018-06 Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs
06/07/2018 Physical Medicine 16-201 Complete ISO 7176-19 Second Edition 2008-07-15 Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)]
08/14/2015 Physical Medicine 16-194 Complete ISO 7176-25 First edition 2013-07-15 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
05/30/2022 Physical Medicine 16-166 Partial ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
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