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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
(click for recognition information)
 
09/17/2018 General II (ES/
EMC)		 19-19 Partial 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
07/28/2025 General II (ES/
EMC)		 19-57 Complete IEC 61326-2-6 Edition 4.0 2025-06 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
12/20/2021 General II (ES/
EMC)		 19-43 Partial IEC 61326-2-6 Edition 3.0 2020-10 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
05/29/2023 General Plastic Surgery/
General Hospital		 6-489 Complete IEC 60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
01/30/2014 General Plastic Surgery/
General Hospital		 6-321 Complete IEC 60601-2-52 Edition 1.0 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
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