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
Related terms
Shared paths + categoryInternational 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.
Application of usability engineering to medical devices.
General requirements for basic safety and essential performance of medical electrical equipment.
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Primary references
3 sources- 1ISO 14971:2019VerifiedISOiso.org
- 2ISO Standards Catalogue - HealthVerifiedISOiso.org
- 3IEC Webstore - Medical EquipmentVerifiedIECwebstore.iec.ch
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