Free access to ISO 13485 standard, other medical device and personal protection equipment standards
To sustain the campaigns taking care of the impact of COVID-19, the International Organization for Standardization (ISO) has made a few of its standards supporting the assessment of medical devices as well as personal protection equipments used in healthcare setups easily accessible free of charge. ISO 13485 pdf or EN ISO 13485 pdf can be consulted for free.
These complimentary ISO requirements are not readily available free of cost download in PDF, however they can be accessed in read-only message style from the main ISO site. For instance, the ISO 13485:2016 standard in PDF format is not available free of cost download– you can access ISO 13485 in read-only (message) format completely free or, if required, acquire the ISO 13485 PDF on the ISO website.
The following ISO standards are available:
- 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 13485 2016 pdf or EN ISO 13485 2016 pdf is the latest version of ISO 13485.
If you are interested in the European market you can contact us for a preliminary discussion. You can also look at our dedicated page for ISO 13485.
