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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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11/08/2005 Radiology 12-6 Complete IEC 60806 First edition 1984-01 Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
07/09/2014 Radiology 12-282 Complete ISO 12609-1 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
05/30/2022 Radiology 12-343 Complete IEC 62127-1 Edition 2.0 2022-03 Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields
03/31/2006 Radiology 12-136 Complete ISO 9236-1 Second edition 2004-02-01 Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
12/19/2022 Radiology 12-349 Complete NEMA PS 3.1 - 3.20 2022d Digital Imaging and Communications in Medicine (DICOM) Set
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
01/30/2014 Physical Medicine 16-165 Complete ISO 7176-14 Second edition 2008-02-15 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - 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
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
05/29/2023 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
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