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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/25/2026 Biocompatibility 2-314 Complete ISO 10993-12 Fifth edition 2021-01 [Including AMD1:2025] Biological evaluation of medical devices - Part 12: Sample preparation and reference materials [Including AMENDMENT 1 (2025)]
05/25/2026 General Plastic Surgery/
General Hospital		 6-521 Complete IEC 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION Corrected Version 2025-11 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
05/25/2026 Neurology 17-23 Partial IEC 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
12/22/2025 Anesthesiology 1-199 Complete ISO 80601-2-70 Third edition 2025-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
12/22/2025 Biocompatibility 2-311 Complete ISO 10993-4 Third edition 2017-04 [Including AMD1:2025] Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including Amendment 1 (2025)]
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