In vitro cytotoxicity

When testing the in-vitro cytotoxicity of medical devices, textiles and other products, the general toxicity of a material is determined in accordance with DIN EN ISO 10993-5.

It is the first test for medical devices as part of a biocompatibility assessment and provides a statement within a few days and without animal testing as to whether toxic components from the material lead to cell damage. In this test, extracts of the materials are prepared (extract method) and added to L929 mouse fibroblasts. After 24 hours of contact of the extracts with the cells, the vitality of the cells is photometrically measured using a biochemical dye. The viability of the cells is evaluated in relation to a control sample, whereby a reduction in cell viability of more than 30 % is considered critical.