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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
05/26/2025 Anesthesiology 1-196 Complete ISO 80601-2-90 First edition 2021-08 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
05/26/2025 General Plastic Surgery/
General Hospital		 6-508 Complete IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
05/26/2025 General Plastic Surgery/
General Hospital		 6-510 Complete IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
05/26/2025 General Plastic Surgery/
General Hospital		 6-512 Complete IEC 60601-2-35 Edition 2.1 2023-12 CONSOLIDATED VERSION Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
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