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.