GLP Research Unit – Skin irritation – skin exposure method.

Skin irritation testing in vivo according to ISO 10993-23 is part of the ISO 10993 series of standards that specialize in the biological evaluation of medical devices. ISO 10993-23 focuses on assessing the potential skin irritation caused by materials or substances that come into contact with the skin due to the use of medical devices, medicinal products, or cosmetics.

The main objective of this test is to determine whether medical devices or their components can cause skin irritation when they come into contact with human skin.

ISO 10993-23 Standard: The skin exposure method utilizes direct application of the tested material or substance to the skin of a rabbit model to evaluate its potential for irritation. This method helps simulate situations encountered in real-life conditions when medical devices may come into contact with the skin during their use.

During the testing process, various parameters are assessed, including skin redness, swelling, and other signs of irritation. These parameters are used to determine the degree of skin irritation caused by the material or substance.

The results of skin irritation testing are used as part of the risk assessment process to determine the safety of the medical device. If a material or substance is found to cause significant skin irritation, it may raise concerns about the safety of the product and lead to further evaluation or the need for design modifications.

At the Silesian Park of Medical Technology Kardio-Med Silesia, testing is conducted following the principles of Good Laboratory Practice (GLP). Thanks to modern equipment in the Small Animal Facility, we ensure suitable living conditions for small animals. The cages in the Animal Facility are individually ventilated and equipped with HEPA filters. Environmental parameters in each room are monitored through an integrated system.

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