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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2024 Radiology 12-355 Complete IEC 60601-2-57 Edition 2.0 2023-07 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
06/07/2018 General Plastic Surgery/
General Hospital		 6-405 Complete 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
12/22/2025 Cardiovascular 3-202 Complete IEC 60601-2-34 Edition 4.0 2024-10 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
12/23/2024 Anesthesiology 1-188 Complete ISO 80601-2-84 Second edition 2023-11 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
05/25/2026 General Plastic Surgery/
General Hospital		 6-521 Complete IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION 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 [Including: Amendment 1 (2023), Interpretation Sheet 1 (2025)]
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