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    ISO-13485-blog

    ISO 13485 & MDR Blog

    ISO enabled free access to ISO 13485 and other medical device and protective clothing standards

    To support the initiatives dealing with the impact of COVID-19, the International Organization for Standardization (ISO) has made some of its standards supporting the biological evaluation of medical devices and protective clothing used in health care settings accessible for free.

    These free ISO standards are not available for free download in PDF, but they can be accessed in read-only text format from the official ISO website. For example, the ISO 13485:2016 standard in PDF format is not available for free download – you can access ISO 13485 in read-only (text) format for free or, if needed, purchase the ISO 13485 PDF on the ISO website.



    The following ISO standards are available in read-only text format:

    • ISO 13485:2016 Medical devices — Quality management systems – Requirements for regulatory purposes
    • ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk
    • 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 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
    • ISO 13688:2013 Protective clothing – General requirements
    • 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

    ISO enabled free access to ISO 13485 and other medical device and protective clothing standards

    To learn which documents are needed to comply with the EU MDR, download this free white paper: EU MDR Checklist of Mandatory Documents.