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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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)]
12/18/2023 Anesthesiology 1-166 Complete ISO 11195 Second edition 2018-01 Gas mixers for medical use - Stand-alone gas mixers
12/19/2022 Anesthesiology 1-153 Complete NFPA 99:2021 Health Care Facilities Code
12/19/2022 Anesthesiology 1-154 Complete ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy
12/19/2022 Anesthesiology 1-155 Complete ISO 10079-2 Fourth edition 2022-03 Medical suction equipment - Part 2: Manually powered suction equipment
12/19/2022 Anesthesiology 1-156 Complete ISO 10079-3 Fourth edition 2022-03 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
12/19/2022 Anesthesiology 1-158 Complete ISO 10079-4 First edition 2021-08 Medical suction equipment - Part 4: General requirements
12/23/2019 Anesthesiology 1-145 Complete ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
12/19/2022 Anesthesiology 1-157 Complete ISO 10079-1 Fourth edition 2022-03 Medical suction equipment - Part 1: Electrically powered suction equipment
12/18/2023 Anesthesiology 1-164 Complete ISO 5361 Fourth edition 2023-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
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