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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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05/29/2024 Anesthesiology 1-177 Complete ISO 80601-2-74 Second edition 2021-07 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
12/18/2023 Anesthesiology 1-165 Complete ISO 80601-2-13 Second edition 2022-04 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
12/18/2023 Anesthesiology 1-163 Complete ISO 80601-2-72 Second edition 2023-06 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
12/19/2022 Anesthesiology 1-160 Complete ISO 80601-2-84 First edition 2020-07 Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
05/30/2022 Anesthesiology 1-152 Complete ISO 80601-2-87 First edition 2021-04 Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
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