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Covid-19 : Essential standards - Respiratory system

AFNOR and ISO have decided to offer the standards you need, free of charge, to help you manage the Covid-19 epidemic outbreak which is raging today worldwide.

You will find bellow the list of standards which will therefore be offered FREE of charge for the duration of the Covid-19 epidemic..

Lung ventilators
ISO 10651-3 : January 1997

Lung ventilators for medical use - Part 3 : particular requirements for emergency and transport 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

ISO 18082/A1 : July 2017

Amendment 1 to standard ISO 18082:2014

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