ISO 10993 Biological Evaluation — Laboratories & Overview
The ISO 10993 series describes a risk-based framework for the biological evaluation of medical devices, with individual parts addressing specific endpoints and chemical characterisation.
When is it used?
- New device submissions
- Material, supplier or sterilisation changes
- Remediating gaps in a biological evaluation file
Sample considerations
- Testing should use final, finished, sterilised devices wherever possible.
- Endpoint selection follows contact type and duration, documented in a biological evaluation plan.