La propagation rapide de COVID-19, déclarée pandémie au niveau mondial, appelle à des mesures urgentes et drastiques de la part des gouvernements, du monde des affaires et des citoyens.
Après la mise à disposition gratuite des normes européennes relatives aux dispositifs de protection et médicaux pour aider à combattre la propagation de COVID-19, l'Organisation internationale de normalisation (ISO) a décidé d'apporter son soutien en mettant gratuitement à disposition (en lecture seule) une série de normes pour aider à combattre la propagation de COVID-19, notamment en lien avec les respirateurs et dispositifs médicaux essentiels.
Les normes suivantes pourront être consultées directement sur le site de l'ISO :
- ISO 374-5:2016 - Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
- ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 13688:2013 - Protective clothing - General requirements
- 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 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 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
- 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 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
Pour tout complément d'informations, l'Organisme luxembourgeois de normalisation se tient à votre disposition via l'adresse normalisation@ilnas.etat.lu