Show simple item record

dc.contributor.authorOrzechowski TJH
dc.contributor.authorMachielsen JCA
dc.contributor.authorGeffen MF van
dc.date.accessioned2012-12-12T23:52:46Z
dc.date.available2012-12-12T23:52:46Z
dc.date.issued1993-08-31
dc.identifier319011005
dc.identifier.urihttp://hdl.handle.net/10029/262309
dc.description.abstractAbstract niet beschikbaar
dc.description.abstractThe 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.
dc.description.sponsorshipDGVGZ/GMV
dc.format.extent30 p
dc.language.isonl
dc.relation.ispartofRIVM Rapport 319011005
dc.relation.urlhttp://www.rivm.nl/bibliotheek/rapporten/319011005.html
dc.subject01nl
dc.subjectmedische hulpmiddelennl
dc.subjectbiocomptabiliteitnl
dc.subjectbioveiligheidnl
dc.subjectmateriaaltestennl
dc.subjecttoxiciteitstestennl
dc.subjectvalidatienl
dc.subjectnormennl
dc.subjectmedical devicesen
dc.subjectbiosafetyen
dc.subjectmaterials testingen
dc.subjecttoxicity testingen
dc.subjectvalidationen
dc.subjectstandardsen
dc.subjecttissue culture agar overlay testen
dc.subjecttcao-testen
dc.titleTissue Culture Agar Overlay Test. Een in vitro cytotoxiciteitstest ter bepaling van biocompatibiliteit van medische hulpmiddelennl
dc.title.alternative[Validation of The Tissue Culture Agar Overlay Test. An in vitro cytotoxicity test to assess the biocompatibility of medical Devices.]en
dc.typeOnderzoeksrapport
dc.date.updated2012-12-12T23:52:47Z
html.description.abstractAbstract niet beschikbaar
html.description.abstractThe 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.


This item appears in the following Collection(s)

Show simple item record