Free availability of COVID-19-related ISO & IEC standards

In the context of the COVID-19 crisis, the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) have made a number of relevant standards and their national adoptions accessible for free in order to support global efforts to deal with the effects on business and organisations.

These standards are now available in read-only format via the ISO Online Browsing Platform (OBP)(external link). Alternatively, if you would like to request one or more of the available standards (see below) in pdf format, please send an email to enquiries@standards.govt.nz with your name, the name of your company or organisation and how you intend to use the standard/s to address COVID-19. We will respond within 5 working days.

• 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 13485:2016, Medical devices — Quality management systems - Requirements for regulatory purposes
• 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 22301:2019, Security and resilience – Business continuity management systems –Requirements
• ISO 22395:2018, Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
• ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management
• ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes
• ISO 31000:2018, Risk management – Guidelines
• 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

Free access to key standards for critical care ventilators

The International Electrotechnical Commission (IEC) is also offering the standards and most relevant normative references for critical care ventilators free of charge to industries that are developing products or converting their existing assembly lines to ventilator production.

• IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

You can request access to these IEC standards by send an email to enquiries@standards.govt.nz with your name, the name of your company or organisation and how you intend to use the standard/s to address COVID-19. We will respond within 5 working days.