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ISO Makes ISO 13485 and Other Relevant Standards Free to Help Fight COVID-19

As we continue to bring you news about QMS implementation, auditing, and certification in the ever-changing landscape of a world that is trying to figure out how to move forward in the face of COVID-19, one of the deadliest pandemics the world has ever known and a force that has created unparalleled disruption in businesses in sectors that operate the world over, we feel overwhelmed by the ways that industries are coming together to combat the virus, whether its medical workers separating themselves from their families to fight on the frontlines, autoworkers who are tooling up to build ventilator parts, or quality professionals that are using their skills to help manufacturers build components necessary to supply life-saving devices and PPE.

Out of the many organizations who are contributing to the global efforts to fight COVID-19, ISO has made several relevant standards freely available on their website to help manufacturers to build devices that comply with international standards.  Of note, of the many standards that they have made freely available, ISO has released a read-only version of ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for regulatory purposes.  If you are a manufacturer that is looking for contracts to build ventilator parts or tooling up to build any other medical device, ISO 13485 is a great place to start in understanding the requirements for your Quality Management System.  The full list of available standards is as follows:

  • 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

Quite frankly, while the virus is obviously horrible and devastating, we love seeing industries and organizations around the world come together to serve a common goal and fight a global enemy.  You can find all of these standards HERE.