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International standards for medical devices

In the context of the COVID-19 crisis ISO and IEC as well as SFS, have temporarily made a number of international standards freely accessible in order to support global efforts to deal with the effects on businesses and organizations.

Please contact SFS customer service by email sales@sfs.fi if you need access to the ISO standards listed below.

The following ISO standards (“licensed materials") are freely accessible in read-only format on SFS Online service. They will be licensed for read-only: users cannot print the licensed materials, content cannot be copied, screen prints are now allowed, licensed materials cannot be copied to a different computer or network file system; and a watermark containing text provided by the content provider is included in the protected licensed materials.

The standards will be protected with FileOpen. For more information about FileOpen please visit www.sfs.fi/DRM

ISO 10651-3:1997, Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators

ISO 10651-4:2002, Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators

ISO 10651-5:2006, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators

ISO 13485:2016, Medical devices — Quality management systems - Requirements for regulatory purposes

ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

ISO 18082:2014, Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including ISO 18082:2014/Amd.1:2017, AMENDMENT 1]

ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter

ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)

ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate

ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics

ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR

ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]

ISO 80601-2-70:2015, Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

ISO 80601-2-79:2018, Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

ISO 80601-2-80:2018, Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors

IEC has decided to exceptionally offer the standards and most relevant normative references for critical care ventilators free of charge to industries who are developing products or converting their existing assembly lines to ventilator production. For more information and asking for license to access the IEC standards, please visit IEC website.