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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Title of Standard
 
 
09/17/2018 General II (ES/
EMC)		 19-19 IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
06/07/2018 General Plastic Surgery/
General Hospital		 6-405 IEC 80601-2-59 Edition 2.0 2017-09 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
07/15/2019 General Plastic Surgery/
General Hospital		 6-421 ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
06/07/2021 General Plastic Surgery/
General Hospital		 6-389 ANSI AAMI IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
06/07/2021 General Plastic Surgery/
General Hospital		 6-461 IEC 60601-2-19 Edition 3.0 2020-09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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