ISO 10993-23 Irritation Testing Laboratories
ISO 10993-23 is the part of the ISO 10993 family addressing irritation, the potential for a device or its extract to cause a local inflammatory response, and it includes in vitro approaches for some device categories.
When is it used?
- Devices with skin, mucosal or breached-surface contact
- Material or process changes on a marketed device
- Programmes seeking in vitro alternatives where the device type allows
Sample considerations
- Ask laboratories which in vitro approaches they can support for your device type and extract.
- Extraction conditions follow the standard and should be confirmed before work starts.
- Sensitisation is a separate endpoint addressed by a different part of the family.