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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
06/07/2018 Anesthesiology 1-137 ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
07/15/2019 Anesthesiology 1-126 ISO 11712 First edition 2009-05-15 Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
08/14/2015 Anesthesiology 1-103 ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment -- Breathing sets and connectors
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
01/14/2019 Anesthesiology 1-138 ISO 80601-2-74 First edition 2017-05 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
08/20/2012 Anesthesiology 1-87 IEC 60601-2-23 Edition 3.0 2011-02 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
01/14/2019 Anesthesiology 1-141 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)]
12/21/2020 Anesthesiology 1-148 ISO 80601-2-69 Second edition 2020-11 Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
12/21/2020 Anesthesiology 1-147 ISO 26825 Second edition 2020-10 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
03/16/2012 Anesthesiology 1-79 ISO 26825 First edition 2008-08-15 Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
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