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In vitro skin irritation

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DIN EN ISO 10993-23 – Biological evaluation of medical devices - Part 23: Tests for irritation

The skin irritation test is used to determine the irritating properties of medical devices and other solid materials and is another important test as part of a biocompatibility assessment in accordance with ISO 10993. In our laboratory, we test skin irritation without animal testing using 3D skin models. In the procedure for medical devices, extracts are first prepared from the samples. The human skin models are then mixed with the material extracts and incubated for a defined period of time. The vitality of the cells is then photometrically determined using a biochemical dye. A reduction in vitality of more than 50 % is considered to be irritating to the skin.


OECD 439 – In vitro skin irritation

Testing for skin irritation in accordance with OECD guidelines is used to determine the irritating properties of chemicals and cosmetics. In our laboratory, we test skin irritation without animal testing using 3D skin models. In this procedure, the substance to be tested is applied directly to the human skin models and incubated with them for a defined period of time. The vitality of the cells is then photometrically determined using a biochemical dye. A reduction in vitality of more than 50 % is considered irritating to the skin.

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List of test standards for In vitro skin irritation
DIN EN ISO 10993-23

Biological evaluation of medical devices – Part 23: Tests for irritation

OECD 439

In vitro skin irritation: Reconstructed Human Epidermis Test Method