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    Dec 1, 2021·IEC · StandardActiveHigh impact

    IEC 81001-5-1 - secure software lifecycle for health software

    IEC 81001-5-1 defines the secure development lifecycle for health software and is the foundational standard for the security risk management activities the FDA and Notified Bodies expect.

    What changed

    • Establishes secure development lifecycle phases parallel to IEC 62304.
    • Defines security risk management vocabulary used by AAMI SW96 and MDCG 2019-16.

    Action for manufacturers

    Map your SDLC to 81001-5-1 phases; reviewers increasingly expect the standard to be cited as the basis for your security activities.

    Primary sources

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