Irritation testing by ISO 10993-23

ISO 10993-23 is an internationally recognized standard for assessing the irritation potential of medical devices when they come into contact with skin, mucosal membranes, or subcutaneous tissues. Irritation tests performed according to the standard are commonly used to demonstrate compliance with EU MDR and FDA requirements.

The appropriate testing approach is chosen based on the body contact site:

• Skin irritation tests evaluate whether a medical device or material causes localized skin irritation when it comes into direct contact with the skin. Testing can be conducted using in vivo or in vitro methods, depending on the device and the market area.

• Intracutaneous reactivity tests are applied to medical devices or materials that penetrate the skin or come into contact with deeper tissues. The goal is to determine whether extracts from such devices cause localized inflammatory responses in the dermis or subcutaneous layers.

The device itself is tested with a direct contact method, when possible. Alternatively, polar and non-polar solvents are used to prepare extracts that simulate potential leachables from the device.

The displayed example price includes an in vivo direct skin irritation test performed under GLP.

For a more accurate quote, do not hesitate to contact us with a description of your device and any additional requirements you may have for testing (e.g., market area, quality systems, in vivo vs. in vitro methods).