The Biocompatibility Irritation test determines if a material or device with which a patient would have contact is an irritant. It measures the reaction to a single, repeated, or continual exposure from device materials that may produce skin, mucosal, or ocular irritation. Irritation is a local tissue response characterized by the usual signs of inflammation, redness, and swelling, and could be accompanied by heat and pain. 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