FAQ

5. Others

Access to key standards for critical care ventilators

In support of the fight against Covid-19, IEC and ISO have decided to exceptionally offer the standards and most relevant normative references for critical care ventilators free of charge to industries who are developing products or converting their existing assembly lines to ventilator production.

Standards provided by IEC:

  • IEC 60601-1:2005+AMD1:2012 CSV, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • 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
  • IEC 60601-1-6:2010+AMD1:2013 CSV, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
  • IEC 60601-1-8:2006+AMD1:2012 CSV, 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
  • 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

    In this case, the IEC Standards will be provided with the following settings:
    - Print restrictions
    - Text copy prevention
    - Watermark

    Enterprises who are developing or manufacturing critical care ventilators for use by Covid-19 patients may access these standards free of charge. To receive the above-mentioned IEC Standards please click here (do not forget to mention your company name, end-user name, email and country).

    Standards provided by ISO: complete list available here

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