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CATÉGORIE: STANDARDS

ISO 10993 (Biocompatibilité)

Une série de normes pour l'évaluation de la sécurité biologique des dispositifs médicaux.

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 10993 is the series of standards for biological evaluation of medical devices, covering cytotoxicity, sensitization, irritation, systemic toxicity, and more.

PROCESS / STEPS

  1. Map device contact category to endpoints.
  2. Perform chemical characterization as appropriate.
  3. Execute or justify biological tests.
  4. Document in biological evaluation report linked to risk management.

EXAMPLES

  • ISO 10993-1 provides the framework; other parts detail specific tests.

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SOURCES

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TERMES CONNEXES

ISO 14971 (Gestion des risques)