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    MedTech Cybersecurity · Since 2022

    All agencies
    Regulatory tracker · agency

    AAMI medical device cybersecurity updates

    Association for the Advancement of Medical Instrumentation

    AAMI consensus standards - TIR57, TIR97, SW96 and related - that the FDA references for medical device cybersecurity risk management.

    1 tracked changeLast reviewed Oct 22, 2026 RSS
    • Mar 31, 2026·Standards draftDraftMedium impact

      ANSI/AAMI SW96 Amendment 1 draft circulated for member review

      Draft amendment clarifies threat modeling traceability, security risk evaluation, and the relationship between SW96 and AAMI TIR57.

      Read details

    Other agencies in the tracker

    • CISA
    • CycloneDX
    • EU Commission
    • FDA
    • HHS 405(d)
    • IEC
    • ISO/IEC
    • MDCG (EU)
    • NIST
    • Red Hat
    • SPDX (Linux Foundation)
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