類別: CLINICAL

生物相容性

醫療器材材料在按預期應用時產生適當宿主反應的能力。按ISO 10993進行的生物相容性測試評估細胞毒性、致敏性、刺激性等生物效應。

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

FDA Biocompatibility ↗

Track regulatory signals related to 生物相容性 across 27 authorities in real time.

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