English 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