Test for Sensitization (ISO 10993-10)

Test for Sensitization (ISO 10993-10)

The Sensitization Test is used to determine the sensitizing activity of medical devices. These tests assess the potential of a material or product to cause a delayed hypersensitivity reaction.

The sensitization test exposes animals to the test substance at multiple induction phases. At 24±2 and 48±2 hours after extraction of test substances/extracts, the application sites of each animal will be observed for evidence of skin sensitization reactions. Sensitivity reactions are noted by observing erythema and edema (redness and swelling) as it interacts with the body's immune system.

Sensitization (sensitivity) tests are performed with 3 different methods for all medical device categories:

• The Guinea Pig Maximization Test (Magnusson-KligmanMethod),
• Closed Patch Test,
• Murine Local Lymph Node Assay (LLNA) test