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CATÉGORIE: STANDARDS

ISO 14971 (Gestion des risques)

La norme internationale pour l'application de la gestion des risques aux dispositifs médicaux, couvrant l'analyse, l'évaluation et le contrôle des risques.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

ISO 14971 is the risk management standard for medical devices across the lifecycle—from design hazards to production and postmarket information.

PROCESS / STEPS

  1. Identify hazards and hazardous situations.
  2. Estimate and evaluate risks; implement risk controls.
  3. Assess residual risk and overall benefit-risk.
  4. Link production and PMS feedback into the risk file.

EXAMPLES

  • A design change triggers risk file update and possibly new verification.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

Système de management de la qualité (SMQ)ISO 13485