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Приведенный ниже список был составлен для поддержки глобальных усилий по преодолению кризиса COVID-19. Они свободно доступны в формате только для чтения на сайте Международной организации по стандартизации (International Organization for Standardization; ISO; ИСО):

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

Обратите внимание, карточки из перечня снабжены ссылками на тексты стандартов, которые размещены в свободном доступе на сайте ISO.

По материалам:
https://www.iso.org/covid19

Ответ COVID-19: Стандарты ISO в свободном доступе

Название документа: Ответ COVID-19: Стандарты ISO в свободном доступе