Sia Analysis
Irritation
Irritation testing, one of the biocompatibility tests within the scope of biological risk assessment of medical devices, is another test that must be applied to almost all medical devices. The requirements and varieties of this test are given in ISO 10993-10 and ISO 10993-23 standards. The possible irritation effect on tissues originating from medical devices is evaluated through irritation tests. Irritation tests may vary depending on the nature of the product and the specific application area. In this context, skin irritation, intradermal irritation, mucosal irritation, and eye irritation tests are performed.