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    Mar 31, 2026·AAMI · 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.

    What changed

    • Tighter language on traceability between threats, hazards, and design controls.
    • Clearer split between SW96 (process) and TIR57 (technical method).

    Action for manufacturers

    Review the draft if you have AAMI access; preview the changes against your current threat-model template so you can re-baseline once the amendment is published.

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