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U.S. Department of Health and Human Services

Recognized Consensus Standards

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07/15/2019 Anesthesiology 1-142 ISO 10079-1 Third Edition 2015-11-01 Medical suction equipment - Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)]
07/15/2019 Anesthesiology 1-116 ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems
04/04/2016 Anesthesiology 1-106 ISO 17510 First Edition 2015-08-01 Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
12/23/2019 Anesthesiology 1-102 ISO 80601-2-69 First edition 2014-07-15 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
12/23/2019 Anesthesiology 1-145 ISO 19223 First edition 2019-07 Lung ventilators and related equipment - Vocabulary and semantics.
01/30/2014 Anesthesiology 1-98 ISO 80601-2-12 First edition 2011-04-15 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)]
01/14/2019 Anesthesiology 1-114 ISO 18835 First Edition 2015-04-01 Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
12/23/2016 Anesthesiology 1-118 ISO 5361 Third edition 2016-09-01 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
07/06/2020 Anesthesiology 1-146 ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
07/15/2019 Anesthesiology 1-144 ISO 80601-2-80 First edition 2018-07 Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
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