En plein contexte de crise du COVID-19, les organisations internationales de normalisation ISO et IEC ont mis gratuitement à disposition un certain nombre de normes internationales visant à soutenir les efforts de lutte contre les conséquences de cette crise. 


Un aperçu des normes mises à disposition est donné ci-dessous. La liste des normes ISO peut être consultée sur https://www.iso.org/covid19.

Cliquez ici pour obtenir la liste des normes IEC. 

Le NBN (Bureau de Normalisation) donne à tous les parties prenantes belges un accès gratuit aux normes relatives aux masques buccaux et aux équipments de protection individuelle. Cliquez ici pour plus d’informations.

 

Normes ISO

  • 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

Normes IEC

  • 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