Irritation / Intracutaneous Reactivity

Irritation is another method of assessing biocompatibility of materials.  Irritation can be assessed using many different models, and the choice of assessment should be based on the end use of the medical device or biomaterial.

The most widely used test is the Intracutaneous Reactivity Test which may be found in both the ISO 10993 and USP standards.  All medical devices are required to have this assessment to comply with ISO 10993.

Other irritation tests that are available include ocular, mucosal and skin.  The objective of these studies are to evaluate localized irritation due to the application or instillation of a test material, test material extract or a test solution.

Tests

Vaginal Irritation Test (ISO), Direct Contact

Vaginal Irritation Test (ISO), 2 Extracts

Primary Skin Irritation (ISO), Direct Contact

Primary Skin Irritation (ISO)

Primary Skin Irritation (ASTM)

Intracutaneous Reactivity Test (USP)

Intracutaneous Reactivity Test (ISO)

Digital Micrographs of Implant Sites

Acute Ocular Irritation Test (7 day)

Acute Ocular Irritation Test (5 day)