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    • Medical equipment in general
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    ISO 14971:2019

    Medical devices — Application of risk management to medical devices

    International Organization for Standardization

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    ISO 20069:2019

    Guidance for assessment and evaluation of changes to drug delivery systems

    International Organization for Standardization

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    IEC 60601-1-2:2014+AMD1:2020

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

    International Electrotechnical Committee

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    IEC 60601-1:2020-09 SER

    Medical electrical equipment - ALL PARTS

    International Electrotechnical Committee

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    IEC 60601-1:2005+AMD1:2012+AMD2 : 2020

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

    International Electrotechnical Committee

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    IEC 60601-1-8:2006+AMD1:2012+AMD2:2020

    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

    International Electrotechnical Committee

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    IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV

    Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

    International Electrotechnical Committee

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    IEC 60601-1-12:2014+AMD1:2020

    Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

    International Electrotechnical Committee

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    IEC 60601-1-10:2007+AMD1:2013+AMD2:2020

    Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers

    International Electrotechnical Committee

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    IEC 60601-1-9:2007+AMD1:2013+AMD2:2020

    Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

    International Electrotechnical Committee

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