Irritation Test

The irritation test is performed to assess the potential for medical devices to cause irritation in combination with single or repeated exposure to the body.

The irritation test is one of the first three tests generally applied in biocompatibility tests. (The other two are in-vitro cytotoxicity and sensitization testing). Irritation test is performed according to ISO 10993-10 standard. Although the ISO 10993-23 standard was published separately for irritation testing, ISO 10993-10 is still valid and compatible with each other.

The basic steps for the irritation query should be as follows.

• Chemical characterization of medical device materials according to ISO 10993-18
• Do a literature search on the irritation potential of materials, as well as chemical and physical properties.

Perform the necessary tests for risk assessment after available information

• First in vitro test (if applicable)
• In-vivo testing if in vitro is not possible
• Non-invasive clinical studies