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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”]

Applicable Standards

  • ISO 10993

Testing Locations

Study Outline

The intracutaneous irritation test evaluates the safety of a biomaterial sample by injecting rabbits intracutaneously with extracts of the test article and associated vehicle controls. Injection sites will be examined and scored at 24 ± 2, 48 ± 2, and 72 ± 2 hours after treatment for signs of skin reactions.