Com vista a apoiar os esforços globais para lidar com a crise causada pelo Covid 19, o Instituto Nacional das Infra-Estruturas de Qualidade (INIQ) em alinhamento com a ISO vem por este meio colocar ao dispor a lista de normas, abaixo indicadas, relacionadas a respiradores e dispositivos médicos essenciais. As respectivas normas também estão disponíveis para visualização no link www.iso.org/covid19, e na eventualidade de interesse pelas mesmas, não hesitem em contactar-nos.
Lista de normas
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
List of standards related to respirators and essential medical devices
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.