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dc.contributor.authorOrzechowski TJH
dc.contributor.authorMachielsen JCA
dc.contributor.authorGeffen MF van
dc.date.accessioned2012-12-12T21:48:58Z
dc.date.available2012-12-12T21:48:58Z
dc.date.issued1993-08-31
dc.identifier319011003
dc.identifier.urihttp://hdl.handle.net/10029/261176
dc.description.abstractAbstract niet beschikbaar
dc.description.abstractIn 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.
dc.description.sponsorshipDGVGZ/GMV
dc.format.extent38 p
dc.language.isonl
dc.relation.ispartofRIVM Rapport 319011003
dc.relation.urlhttp://www.rivm.nl/bibliotheek/rapporten/319011003.html
dc.subject01nl
dc.subjectmedische hulpmiddelennl
dc.subjectbiocompatibiliteitnl
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.subjectcell growth inhibition testen
dc.titleCelgroeiremmingstest voor bepaling van de biocompatibiliteit van medische hulpmiddelennl
dc.title.alternative[Cell growth inhibition test, Validation in the determination of the biocompatibility of Medical Devices.]en
dc.typeReport
dc.date.updated2012-12-12T21:48:59Z
html.description.abstractAbstract niet beschikbaar
html.description.abstractIn 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.


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