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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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
01/30/2014 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)]
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
08/14/2015 Anesthesiology 1-105 ISO 80601-2-72 First edition 2015-04-11 Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
04/04/2016 Anesthesiology 1-115 ISO 80601-2-70 First Edition 2015-01-15 Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
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