The Sensitization test is used for the determination of sensitizing activity of chemicals and medical devices. These tests are assessing the potential of a material or product to cause a delayed hyper-sensitivity reaction.
The sensitization test exposes the animals to the test article extracts or test article across multiple induction phases, and a single challenge phase. The challenge sites of each animal will be observed for evidence of skin sensitizations reactions 24±2 and 48±2 hours after removal of the test articles/extracts. Sensitization reactions are noted by observing erythema and/or edema (redness and swelling) as it interacts with the body’s immune system.
This test complies with ISO 10993-10 and ISO 10993-12 standards.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA “Use of international standard ISO 10993-1”]
- ISO 10993-10
- ISO 10993-12