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  • International Standards Contribute to the Battle against COVID-19

    SAC 2020/04/26 15:14:51

    To jointly contain the epidemic, empowered by ISO and IEC and approved by SAC, the national portal on standards information services has made the full texts of 32 international standards related to epidemic prevention and control available for reading free of charge.


    By far, a total of 28 ISO standards and 5 IEC standards are available on the website (https://www.sacinfo.cn/isoOpen), contributing practical standards actions for winning the battle against COVID-19. Interested enterprises, public institutions and individuals can get access to these standards.


    As a permanent member of ISO and IEC, SAC will fulfill its responsibilities and obligations in protecting the international standards copyrights.


    The international standards are as follows:
    1.ISO 374-5: 2016, Protective gloves against dangerous chemicals and micro-organisms-Part 5: Terminology and performance requirements for micro-organisms risks
    2.ISO 10993-1: 2018, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
    3.ISO 13688: 2013, Protective clothing-General requirements
    4.ISO 22301: 2019, Security and resilience-Business continuity management systems-Requirements
    5.ISO 22395: 2018, Security and resilience-Community resilience-Guidelines for supporting vulnerable persons in an emergency
    6.ISO 22320: 2018, Security and resilience-Emergency management-Guidelines for incident management
    7.ISO 22316: 2017, Security and resilience-Organizational resilience-Principles and attributes
    8.ISO 31000: 2018, Risk management-Guidelines
    9.ISO 10651-3: 1997, Lung ventilators for medical use-Part 3: Particular requirements for emergency and transport ventilators
    10.ISO 10651-4: 2002, Lung ventilators-Part 4: Particular requirements for operatorpowered resuscitators
    11.ISO 10651-5: 2006, Lung ventilators for medical use-Particular requirements for basic safety and essential performance-Part 5: Gas-powered emergency resuscitators
    12.ISO 13485: 2016, Medical devices-Quality management systems-Requirements for regulatory purposes
    13.ISO 17510: 2015, Medical devices-Sleep apnoea breathing therapy-Masks and application accessories
    14.ISO 18082: 2014, Anaesthetic and respiratory equipment-Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including ISO 18082:2014/Amd.1:2017, AMENDMENT 1]
    15. ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 1: Evaluation and testing within a risk management process
    16.ISO 18562-2: 2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 2: Tests for emissions of particulate matter
    17.ISO 18562-3: 2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 3: Tests for emissions of volatile organic compounds (VOCs)
    18.ISO 18562-4: 2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications-Part 4: Tests for leachables in condensate
    19.ISO 19223: 2019, Lung ventilators and related equipment-Vocabulary and semantics
    20.ISO 20395: 2019, Biotechnology-Requirements for evaluating the performance of quantification methods for nucleic acid target sequences-qPCR and dPCR
    21.ISO 5356-1: 2015, Anaesthetic and respiratory equipment-Conical connectors-Part 1: Cones and sockets
    22.ISO 80601-2-12: 2020, Medical electrical equipment-Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    23.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]

    24.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

    25.ISO 80601-2-74: 2017, Medical electrical equipment-Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
    26.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
    27.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
    28.ISO/TS 16976-8: 2013, Respiratory protective devices-Human factors-Part 8: Ergonomic factors
    29.IEC 60601-1: 2005+AMD1: 2012 CSV, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
    30.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
    31.IEC 60601-1-6: 2010, Medical electrical equipment-Part 1-6: General requirements for basic safety and essential performance-Collateral standard: Usability
    32.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
    33.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


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