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ISO предоставя безплатен достъп до стандарти в помощ на усилията за справяне с кризата COVID-19

На 16ти април, 2020 г. Международната организация за стандартизация (ISO) предостави безплатен достъп до 28 стандарта, публикувани от нея. Решението е взето с цел да се подпомогнат усилията за справяне с кризата, предизвикана от COVID-19, в глобален мащаб.

Стандартите са достъпни само за четене.

За Ваше улеснение предоставяме линковете по групи.

Безплатен достъп до стандарти за сигурност, устойчивост и управление на риска

  • 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

Безплатен достъп до стандарти за лични предпазни средства

  • ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
  • ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk)
  • ISO 13688:2013, Protective clothing – General requirements

Българският институт за стандартизация също предоставя безплатен достъп до тези три стандарта въз основа на Решение 15/20 от 2020 г. от извънредна онлайн сесия на Председателския комитет на CEN/CENELEC. Тъй като стандартите са разработвани съвместно с ISO, са спазени указанията на организацията за предоставяне на достъп само за четене. За целта трябва да се регистрирате тук.

Безплатен достъп до стандарти за белодробни вентилатори

  • 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 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics

Безплатен достъп до стандарти за медицински изделия

  • 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 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/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors

Безплатен достъп до стандарти за оценка на биосъвместимост

  • 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

Безплатен достъп до стандарти за електромедицински апарати

  • 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

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