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Irritation Testing is most often performed in an animal model using skin or mucous membranes to determine the potential for local irritation of medical devices, materials or extracts. The exposure and contact time of the skin, eyes, mucosa should be similar to the anticipated clinical use of the medical device.
In the intracutaneous test, extracts from the test material and blank are injected intradermally. Injection sites are scored for erythema and edema (redness and swelling). This procedure is recommended for devices that will communicate externally or have internal contact with the body or body fluids. It reliably detects the potential for local irritation due to the chemicals that may be derived from the biomaterial.
Mucosal membrane irritation tests are recommended for devices that will communicate externally with external natural channels or tissues and generally use extracts rather than the material itself. Some common procedures include vaginal, oral, rectal, penile and ocular irritation studies.
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