Skin Irritation

Skin Irritation

Skin Irritation / Intracutaneous Reactivity testing evaluates the localised inflammatory response of skin or subcutaneous tissue to a device or its extract. Per ISO 10993-23 and ISO 10993-10, it is a required endpoint for medical devices in surface or external-communicating contact with the patient.

Our irritation programme covers polar and non-polar extracts, dose-response titration where appropriate, and qualified scoring readouts — producing compliant data to support 510(k), CE-mark and MDR submissions.