--- title: "ISO 14971, Definition | MedTech Terms" description: "International standard for the application of risk management to medical devices. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ISO 14971 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system) # ISO 14971 International standard for the application of risk management to medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 14971:2019 specifies terminology, principles, and a process for risk management of medical devices, including software and in-vitro diagnostics, throughout the device lifecycle. ## What this means in practice Risk management per ISO 14971 underpins [design controls](/terms/design-controls), cybersecurity risk decisions, [post-market surveillance](/terms/post-market-surveillance), and benefit-risk determinations expected by FDA, EU notified bodies, and other regulators. ## Use cases 1 scenario 1 ### Risk file for an AI-enabled radiology triage tool Risk Management lead The team builds a [risk management file](/terms/risk-management-file): hazard analysis covering false negatives, automation bias, and model drift; risk controls including human-in-the-loop review and performance monitoring; and a benefit-risk conclusion tied to clinical evidence. Outcome The file supports both FDA and EU [MDR](/terms/mdr-reporting) submissions and drives the post-market performance monitoring plan. ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Hazard, Hazardous Situation, and Harm ](/terms/hazard-vs-harm) - [ Risk Management File(RMF) ](/terms/risk-management-file) - [ Failure Mode and Effects Analysis(FMEA) ](/terms/fmea) - [ Fault Tree Analysis(FTA) ](/terms/fta) ### Used by Things that build on this term. - [ Benefit-Risk Determination ](/terms/benefit-risk) ### Overlaps with Covers some of the same ground; not interchangeable. - [ ISO/IEC 23894 ](/terms/iso-iec-23894) ### See also Closely related context worth reading. - [ ISO/TR 24971 ](/terms/tr24971) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485)[ Quality & Risk Risk Management File(RMF) Set of records and outputs from the ISO 14971 risk management process. ](/terms/risk-management-file)[ Standards ISO/TR 24971 Guidance on the application of ISO 14971 to medical devices. ](/terms/tr24971)[ Regulatory Benefit-Risk Determination Assessment weighing probable benefits against probable risks of a device. ](/terms/benefit-risk) ### Risk & Usability Deep Dive · From this learning path [ Standards IEC 62366-1 Application of usability engineering to medical devices. ](/terms/iec-62366-1?from=risk-and-usability)[ Clinical & Trials Human Factors Engineering(HFE) Engineering discipline focused on safe and effective device use by intended users. ](/terms/human-factors?from=risk-and-usability)[ Regulatory Labeling All written, printed, or graphic matter on or accompanying a device. ](/terms/labeling?from=risk-and-usability)[ Quality & Risk Risk Acceptability Matrix Pre-defined matrix mapping severity × probability combinations to acceptable, ALARP, or unacceptable risk. ](/terms/risk-acceptability-matrix?from=risk-and-usability) ### Standards Stack for Medical Devices · From this learning path [ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. Adjacent lesson ](/terms/iec-60601-1?from=standards-stack)[ Standards IEC 60601-1-2 EMC requirements for medical electrical equipment. ](/terms/iec-60601-1-2?from=standards-stack)[ Standards IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304?from=standards-stack)[ Standards ISO 10993-1 Biological evaluation of medical devices within a risk management process. ](/terms/iso-10993-1?from=standards-stack) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [Risk & Usability Deep Dive](/paths/risk-and-usability)Lesson 1 of 9 - [Standards Stack for Medical Devices](/paths/standards-stack)Lesson 2 of 10 Ecosystems (1) - [Quality System](/ecosystems/quality-system) Comparisons (1) - [IEC 62304 vs ISO 14971](/compare/iec-62304-vs-iso-14971)vs IEC 62304 ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 IEC· 1 1. [1 ISO 14971:2019 Verified ISO · iso.org ](https://www.iso.org/standard/72704.html) 2. [2 ISO Standards Catalogue - Health Verified ISO · iso.org ](https://www.iso.org/ics/11/x/) 3. [3 IEC Webstore - Medical Equipment Verified IEC · webstore.iec.ch ](https://webstore.iec.ch/searchform&q=medical) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Implementing this standard on a device program? Blue Goat Cyber helps MedTech teams operationalize cybersecurity standards across the design and post-market lifecycle. [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 Standards Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=iso-14971) Learn in 60 seconds Card Lesson Quiz International standard for the application of risk management to medical devices. - · Risk management per ISO 14971 underpins design controls, cybersecurity risk decisions, post-market surveillance, and benefit-risk determinations expected by FDA, EU notified bodies, and other regulators. Remember this International standard for the application of risk management to medical devices. Related terms - [Risk Management File(RMF) ](/terms/risk-management-file) - [Benefit-Risk Determination ](/terms/benefit-risk) - [ISO 13485 ](/terms/iso-13485) - [ISO/TR 24971 ](/terms/tr24971) You may also need Auto-suggested from Standards and shared keywords. - [AAMI SW96 ](/terms/aami-sw96) - [ISO 10993-1 ](/terms/iso-10993-1) - [AAMI TIR57 ](/terms/aami-tir57) - [AAMI TIR97(TIR97) ](/terms/aami-tir97) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [IEC 62366-1 ](/terms/iec-62366-1) [All Standards terms](/terms?cat=Standards) 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 Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.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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