What it is
The bridge between ISO 14971 (safety risk) and IEC 80001 / IEC 62443 (security risk). FDA names it as a recognised consensus standard.
Why it matters
If you reference TIR57 in your risk management plan, the FDA accepts the structure with little debate. Increasingly cited in SFDA and Health Canada too.
Adopted or referenced by
FDA Health Canada SFDA
Key clauses
Security risk = patient safety risk
Threats are evaluated for impact on safety, effectiveness and data.
Threat modelling
STRIDE-based approach commonly applied.