Which biocompatibility tests does my device need, and who runs them?
ISO 10993-1 sets a risk-based biological evaluation: endpoints depend on body contact and duration. Individual tests such as cytotoxicity (ISO 10993-5) are often ordered singly; the overall plan should come first.
What the method covers
Finished devices and materials; GLP may be required for regulatory submissions.
Applicability caveats
- Ordering a 'standard panel' without an evaluation plan can waste animals and money.
- Sterilization residuals (ISO 10993-7) apply to EO-sterilized devices.
- Labs report test results; the manufacturer completes the biological evaluation.