ISO 10651-3 : January 1997
Lung ventilators for medical use - Part 3 : particular requirements for emergency and transport ventilators
Lung ventilators
ISO 10651-4 : March 2002
Lung ventilators -- Part 4: particular requirements for operator-powered resuscitators
ISO 10651-5 : February 2006
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5 : gas-powered emergency resuscitators
Medical devices
ISO 13485 : March 2016
Medical devices - Quality management systems - Requirements for regulatory purposes - Dispositifs médicaux
Sleep apnoea breathing therapyl
ISO 17510 : August 2015
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories - Dispositifs médicaux
Anaesthetic and respiratory equipment
ISO 18082 : June 2014
Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
Biocompatibility evaluation of breathing gas
ISO 18562-1 : March 2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1 : evaluation and testing within a risk management process
ISO 18562-2 : March 2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3 : March 2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs)
ISO 18562-4 : March 2017
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
Lung ventilators
ISO 19223 : July 2019
Lung ventilators and related equipment - Vocabulary and semantics
Anaesthetic and respiratory equipment
ISO 5356-1 : March 2015
Anaesthetic and respiratory equipment - Conical connectors - Part 1 : Cones and sockets
ISO 80601-2-12 : February 2020
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13 : August 2011
Medical electrical equipment - Part 2-13 : particular requirements for basic safety and essential performance of an anaesthetic workstation
ISO 80601-2-70 : January 2015
Medical electrical equipment - Part 2-70 : particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
ISO 80601-2-74 : May 2017
Medical electrical equipment - Part 2-74 : particular requirements for basic safety and essential performance of respiratory humidifying equipment
ISO 80601-2-79 : July 2018
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
ISO 80601-2-80 : July 2018
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
Respiratory protective devices
ISO/TS 16976-8 : June 2013
Respiratory protective devices - Human factors - Part 8 : ergonomic factors