Free Access to ISO 13485 for COVID-19 Support
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To support efforts against COVID-19, the International Organization for Standardization (ISO) has made certain standards accessible for free. These standards are crucial for the biological evaluation of medical devices and protective clothing used in healthcare settings.
While these free ISO standards are not available for free download in PDF format, they can be accessed in read-only text format on the official ISO website. For example, the ISO 13485:2016 standard PDF is not available for free download, but you can access it in read-only (text) format for free or purchase the PDF if needed.
Available ISO Standards 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 apnea 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.
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.
ISO 80601-2-70:2015: Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnea 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.
These standards provide critical guidance and requirements to ensure the safety and efficacy of medical devices and protective equipment, especially during the ongoing pandemic. Accessing these standards helps manufacturers and healthcare providers stay compliant and informed.
