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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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12/23/2024 Anesthesiology 1-187 Complete ISO 80601-2-12 Third edition 2023-11 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
05/26/2025 Radiology 12-380 Complete IEC 60601-2-37 Edition 3.0 2024-07 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
06/27/2016 Radiology 12-293 Complete IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
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
01/14/2019 Anesthesiology 1-141 Complete ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
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)]
06/07/2021 Anesthesiology 1-151 Complete ISO 80601-2-70 Second edition 2020-11 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
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)]
01/14/2019 ObGyn/
Gastroenterology/
Urology		 9-121 Complete IEC 60601-2-16 Edition 5.0 2018-4 Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
ANSI AAMI IEC 60601-2-16:2018 Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
05/30/2022 General II (ES/
EMC)		 19-47 Complete ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
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