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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Title of Standard
 
 
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
03/16/2012 Anesthesiology 1-73 ANSI AAMI ISO 10651-4:2002 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators
ISO 10651-4 First edition 2002-03-01 Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
01/30/2014 Anesthesiology 1-78 ASME PVHO-1-2007 Safety Standard for Pressure Vessels for Human Occupancy
06/07/2018 Anesthesiology 1-133 ISO 10079-3 Third Edition 2014-05-01 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
01/30/2014 Anesthesiology 1-81 CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
08/21/2017 Anesthesiology 1-127 ISO 16628 First edition 2008-11-15 Tracheobronchial tubes-Sizing and marking
03/16/2012 Anesthesiology 1-72 ANSI AAMI ISO 10651-5:2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
03/31/2006 Anesthesiology 1-67 NFPA 99:2005 Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities
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
07/06/2020 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
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