All terms
AAMI TIR57
AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
AAMI TIR57:2016 "Principles for medical device security - Risk management" is a technical information report that adapts general security risk-management principles to medical devices, with explicit bridges to ISO 14971 (safety risk management) and IEC 80001 (network risk). TIR57 is the MedTech-specific reference for integrating cybersecurity risk into the existing safety risk management file rather than running it as a separate process. What the regulation says
FDA's 2023 guidance cites TIR57 as a relevant consensus standard. The integration of cybersecurity risk with ISO 14971 safety risk that TIR57 prescribes is exactly the unified risk picture FDA reviewers expect.
What this means in practice
TIR57 is most useful as the bridge document that lets MedTech risk and security teams speak the same language. Together with TIR97 (post-market security risk management) it forms the AAMI cybersecurity playbook. Common pitfalls
- •Treating cybersecurity risk and safety risk as parallel processes producing two different files.
- •Ignoring TIR97 for post-market - TIR57 is the design-side reference, TIR97 covers the operational side.
Frequently asked questions
No - it's a Technical Information Report (TIR), which is a consensus document but not a normative standard. FDA recognizes it as guidance for cybersecurity risk management.
Primary references
3 sourcesLink health: 1 verified 1 bot-blocked 1 needs review· last checked 2026-05-09
AAMI·1FDA·1HSCC·1
- 1
AAMI TIR57:2016Needs reviewAAMIaami.org
- 2
FDA Cybersecurity Guidance (Sept 2023)Bot-blockedFDAfda.gov
- 3
HSCC - Health Sector Coordinating CouncilVerifiedHSCChealthsectorcouncil.org
Inline markers like [1] jump to the matching reference above.