ISO 14971
International standard for the application of risk management to medical devices.
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, cybersecurity risk decisions, post-market surveillance, and benefit-risk determinations expected by FDA, EU notified bodies, and other regulators.Use cases
1 scenarioRisk file for an AI-enabled radiology triage tool
Risk Management leadThe team builds a 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.
Cross-references
Uses
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Used by
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Overlaps with
Covers some of the same ground; not interchangeable.
See also
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Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsInternational standard for medical device quality management systems.
Set of records and outputs from the ISO 14971 risk management process.
Guidance on the application of ISO 14971 to medical devices.
Assessment weighing probable benefits against probable risks of a device.
Risk & Usability Deep Dive
· From this learning pathApplication of usability engineering to medical devices.
Engineering discipline focused on safe and effective device use by intended users.
All written, printed, or graphic matter on or accompanying a device.
Pre-defined matrix mapping severity × probability combinations to acceptable, ALARP, or unacceptable risk.
Standards Stack for Medical Devices
· From this learning pathGeneral requirements for basic safety and essential performance of medical electrical equipment.
EMC requirements for medical electrical equipment.
Lifecycle requirements for medical device software.
Biological evaluation of medical devices within a risk management process.
Where this term appears across MedTech Terms.
- Risk & Usability Deep DiveLesson 1 of 9
- Standards Stack for Medical DevicesLesson 2 of 10
- IEC 62304 vs ISO 14971vs IEC 62304
Primary references
3 sources- 1
ISO 14971:2019VerifiedISOiso.org
- 2
ISO Standards Catalogue - HealthVerifiedISOiso.org
- 3
IEC Webstore - Medical EquipmentVerifiedIECwebstore.iec.ch
Inline markers like [1] jump to the matching reference above.