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CATÉGORIE: CLINICAL
Biocompatibilité
La capacité d'un matériau de dispositif médical à produire une réponse appropriée de l'hôte lors de l'utilisation prévue.
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
Biocompatibility is the appropriateness of device materials for patient contact, evaluated primarily via ISO 10993 endpoints based on nature and duration of contact.
PROCESS / STEPS
- Characterize materials and contact type/duration.
- Select ISO 10993 endpoints; leverage chemical characterization where rational.
- Test or justify waivers with toxicological risk assessment.
- Update evaluations after material/process changes.
EXAMPLES
- Implantable devices require broader endpoints than intact-skin contact devices.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Biocompatibilité across 27 authorities in real time.
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