The Irritation test(s) can be used to determine if a material or chemical will cause local irritation in the skin, mucosal, or ocular tissues. The test article extracts are dosed or the test article is directly applied to the animal. The dosed sites will be examined and scored at 24 ± 2, 48 ± 2, and 72 ± 2 hours after treatment. The scoring will measure the irritation reaction (erythema and edema) to a single, repeated, or continual exposure from device materials or chemicals.
This test complies with ISO 10993-12 and ISO 10993-23 standards.
Download the biocompatibility test matrix. [Based on ISO 10993-1:2018 (E) and FDA “Use of international standard ISO 10993-1”]
Applicable Standards
- ISO 10993-12
- ISO 10993-23
