Medical Devices Sensitization Testing

It may cause itching, swelling and redness of the skin in sensitive individuals due to substances that cause an allergic response, such as allergic contact dermatitis, after medical devices come into contact with the skin. Evaluation of medical devices and their constituent materials in terms of their potential to cause irritation and skin sensitization is evaluated within the scope of the Sensitization Test.

Sensitization Tests in medical devices are generally as follows:

• Sample selection - selection of representative parts from a medical device,
• Preparation of extracts,
• Pretest for irritation including in silico and in vitro methods for dermal exposure,
• In vivo (irritation and sensitization) testing,
• Interpretation of results.

ISO 10993- 10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-12: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials