ISO is providing free access to Covid-19 related tools

ISO is providing free access to medical device manufacturers

Because of the global pandemic, the ISO is providing free access to Covid-19 related standards.  This is something that doesn’t happen every day.  The International Organization of Standardization  is giving an opportunity to view various standards that are applicable to the medical and medical device industries.  The following is a list of what is available in read-only format:

  • 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

This action has been coordinated with the International Electrotechnical Commission (IEC), who are making complementary standards freely available at go.iec.ch/covid19faq.

The very fact that ISO is providing free access to some of its standards clearly demonstrates their commitment to sharing resources during the global crisis.

If you need assistance ensuring that your organization is conforming to the latest standards, contact G3 Solutions today!

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