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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 1-186 Complete ISO 80601-2-80 Second edition 2024-08 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
05/29/2023 ObGyn/
Gastroenterology/
Urology
9-149 Complete IEC 60601-2-39 Edition 3.0 2018-04 Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
05/29/2023 Radiology 12-351 Complete IEC 60601-2-43 Edition 3.0 2022-12 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures
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
03/16/2012 Radiology 12-242 Complete IEC 60601-2-57 Edition 1.0 2011-01 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 and cosmetic/aesthetic use
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