类别: CLINICAL

生物相容性

医疗器械材料在按预期应用时产生适当宿主反应的能力。按ISO 10993进行的生物相容性测试评估细胞毒性、致敏性、刺激性等生物效应。

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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