ISO 10993-3 Genotoxicity Testing Laboratories
ISO 10993-3 is the part of the ISO 10993 family addressing genotoxicity and related endpoints, applied where the biological evaluation identifies a need for that data rather than as a universal requirement.
When is it used?
- Devices with prolonged or permanent contact, or internal tissue or blood contact
- Novel materials, additives or colourants without an established use history
- Where chemical characterisation identifies substances lacking adequate toxicological data
Sample considerations
- Extract preparation and assay selection follow the standard and should be agreed with the laboratory before work starts.
- Device quantities are significant; confirm requirements early.
- Share existing chemical characterisation — it can change the scope or need.