ISO 10993-10 Sensitization Testing Laboratories
ISO 10993-10 is the part of the ISO 10993 family addressing skin sensitisation, the potential for a device or its extract to provoke an allergic response after repeated exposure.
When is it used?
- Devices contacting skin, mucosal membranes or breached surfaces
- New adhesives, elastomers, coatings or colourants
- Complaint investigations reporting skin reactions
Sample considerations
- Polar and non-polar extracts are commonly required; conditions follow the standard.
- Send finished, sterilised devices including skin-contacting adhesives and liners.
- Irritation is a separate endpoint addressed by a different part of the family.