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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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01/14/2019 Anesthesiology 1-138 Complete ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
12/23/2019 General Plastic Surgery/
General Hospital		 6-438 Complete IEC 80601-2-77 Edition 1.0 2019-07 Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
ANSI AAMI IEC 80601-2-77:2020 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
12/20/2021 Physical Medicine 16-232 Complete IEC 80601-2-78 Edition 1.0 2019-07 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
07/15/2019 Anesthesiology 1-143 Complete ISO 80601-2-79 First edition 2018-07 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
06/27/2016 Radiology 12-301 Complete IEC 60601-2-8 Edition 2.1 b:2015 Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
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