Medical device irritation testing is a highly regulated industry (read more about medical device cleaning and validation) with requirements for cleaning, sterilization, reprocessing, and irritation testing. Similar to biocompatibility, irritation testing determines whether the material or the device itself will cause any irritation.
Medical device irritation testing is done to measure the reaction that a single exposure or repeated exposure to the device and its materials may have on the skin or inside the body. Irritation is characterized by inflammation, redness, swelling, heat, and/or pain.
Irritation testing is mandated by international standards and FDA regulations. Tests for irritation are done on the skin and mucous membranes (such as around the eye and nose) and determine the amount of exposure before irritation (if any) occurs.
Irritation can occur from chemicals in the device and its materials, some causing immediate reactions and others causing delayed reactions. ISO 10993-10 presents a four-tier approach to understanding and determining a device’s potential to cause irritation. First, manufacturers must determine whether there have been reports of irritation caused by the chemical or material in question. Second, find valid in vitro tests that identify irritation materials. If a material cannot be ruled out by steps one or two, the third step is to perform in vivo testing (either intracutaneous, primary skin, or ocular irritation) on the chemical or material to determine the irritation potential. Lastly, a noninvasive clinical study on people may need to be carried out.
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