Tissue Culture Agar Overlay Test. Een in vitro cytotoxiciteitstest ter bepaling van biocompatibiliteit van medische hulpmiddelen
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Open Access
Type
Report
Language
nl
Date
1993-08-31
Research Projects
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Journal Issue
Title
Tissue Culture Agar Overlay Test. Een in vitro
cytotoxiciteitstest ter bepaling van biocompatibiliteit van medische
hulpmiddelen
Translated Title
[Validation of The Tissue Culture Agar Overlay
Test. An in vitro cytotoxicity test to assess the biocompatibility of
medical Devices.]
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Abstract
Abstract niet beschikbaar
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.
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.
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DGVGZ/GMV