COVID-19 response: freely available ISO standards

The below list has been compiled to support global efforts in dealing with the COVID-19 crisis. They are freely available in read-only format.

ACCESS THESE ON THE ISO WEBSITE

• ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risk
• ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
• 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 13485:2016, Medical devices — Quality management systems - Requirements for regulatory purposes
• ISO 13688:2013, Protective clothing – General requirements
• ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors
• 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 22301:2019, Security and resilience – Business continuity management systems –Requirements
• ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes
• ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management
• ISO 22395:2018, Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
• ISO 22609:2004, Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
• ISO 31000:2018, Risk management – Guidelines
• 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