--- title: "AAMI TIR57, Definition | MedTech Terms" description: "AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. Plain-English Cybersecurity definition for MedTech teams" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/aami-tir57#term", "name": "AAMI TIR57", "alternateName": "Principles for Medical Device Security - Risk Management", "description": "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). 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FDA recognizes it as guidance for cybersecurity risk management." } }, { "@type": "Question", "name": "How does TIR57 relate to ISO 14971?", "acceptedAnswer": { "@type": "Answer", "text": "TIR57 specifies how to integrate cybersecurity risk into the ISO 14971 risk management framework so safety and security risks share a single, coherent file." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. AAMI TIR57 [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Quality System](/ecosystems/quality-system) # AAMI TIR57 AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition [AAMI](/terms/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](/terms/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](/terms/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](/terms/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](/terms/aami-tir97) (post-market security risk management) it forms the [AAMI](/terms/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 Is AAMI TIR57 a standard? 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. How does TIR57 relate to ISO 14971? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity IEC 80001-1 International standard for risk management of IT networks that incorporate medical devices. ](/terms/iec-80001)[ Cybersecurity Premarket Cybersecurity Submission The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device. ](/terms/premarket-cybersecurity)[ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b)[ Cybersecurity Secure Product Development Framework(SPDF) A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle. ](/terms/spdf) ### More in Cybersecurity · Same category [ Cybersecurity Threat Modeling A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat. ](/terms/threat-modeling)[ Cybersecurity AAMI SW96 AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ Cybersecurity AAMI TIR97(TIR97) AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57. ](/terms/aami-tir97)[ Cybersecurity Brainjacking Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient. ](/terms/brainjacking) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 HSCC· 1 CISA· 1 1. [1 FDA Cybersecurity Guidance (Sept 2023) Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions) 2. [2 HSCC - Health Sector Coordinating Council Verified HSCC · healthsectorcouncil.org ](https://healthsectorcouncil.org/) 3. [3 CISA - Healthcare and Public Health Sector Verified CISA · cisa.gov ](https://www.cisa.gov/topics/critical-infrastructure-security-and-resilience/critical-infrastructure-sectors/healthcare-and-public-health-sector) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on medical device cybersecurity? Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Cybersecurity Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=aami-tir57) Learn in 60 seconds Card Lesson Quiz AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. - · 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. - · 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. Remember this Watch out: Treating cybersecurity risk and safety risk as parallel processes producing two different files. Related terms - [Threat Modeling ](/terms/threat-modeling) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [IEC 80001-1 ](/terms/iec-80001) - [Secure Product Development Framework(SPDF) ](/terms/spdf) You may also need Auto-suggested from Cybersecurity and shared keywords. - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [AAMI SW96 ](/terms/aami-sw96) - [Risk Management File(RMF) ](/terms/risk-management-file) - [AAMI TIR45(TIR45) ](/terms/aami-tir45) - [HSCC Joint Security Plan(HSCC JSP) ](/terms/hscc-jsp) - [Manufacturer Disclosure Statement for Medical Device Security(MDS2) ](/terms/mds2) [All Cybersecurity terms](/terms?cat=Cybersecurity) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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