CATEGORY: CLINICAL

Biocompatibility

The ability of a medical device material to perform with an appropriate host response when applied as intended. Biocompatibility testing per ISO 10993 evaluates cytotoxicity, sensitization, irritation, and other biological effects.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Biocompatibility across 27 authorities in real time.

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