Abstract

In order to assess the biocompatibility of medical devices a set of test norms has been developed by the ISO (International Organisation for Standardisation) and the CEN/CENELEC (Comite Europeen de Normalisation, Comite Europeen de Normalisation Electrotechnique). Cytotoxicity tests play an important role in the testmatrix of biocompatibility testing. The agar overlay test is an internationally accepted standard test for determination of the cytotoxicity of biomaterials. Because of the disadvantages mentioned in the introduction a fast, reproducible and quantitative cytotoxicity test has been developed. Extracts of medical devices are tested for their effect on celgrowth. A detailed testprotocol and the validation results of this celgrowth inhibition test are described. In addition some applications are presented. From the results we conclude that the celgrowth inhibition test is sensitive and reproducible. Also induced cytotoxic effects of extracts (sheep collagen, non-wovens) and desinfectantia/sterilants (EtO) can be detected.