Biological Evaluation of Medical Products

(DIN EN ISO 10993-5)

In-vitro Cytotoxicity
The biological evaluation of medical products and the related examinations of the compatibility of these products have become increasingly important. The contact of patients with medical devices of any type may cause acute and/or chronic toxic reactions.

Both residual matter from manufacturing or reprocessing, and potentially toxic, leachable substances from the materials may cause such adverse effects, and negatively influence the biocompatibility.

In the cytotoxicity test (DIN EN ISO 10993-5, MD5.0), soluble components are extracted from the medical device. To determine the cytotoxicity, the effect of the extract on living cells is investigated. (DIN EN ISO 10993-12).