English Abstract The Tissue Culture Agar Overlay Test (TCAO-test), an
indirect contact in vitro cytotoxicity assay, has been validated and made
available for practical applications concerning medical device safety
testing. This assay fits in the test matrix as presented by the
International Organisation for Standardisation (ISO) and will be adopted in
the European Biocompatibility testing scheme of CEN (Comite Europeen de
Normalisation). Forthcoming Notified Bodies may apply this TCAO-test
complying with the essential requirements of the Active Implantable Medical
Device Directive. The detailed testprotocol is described and testresults
are presented.
