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dc.contributor.authorMachielsen JCA
dc.contributor.authorOrzechowski TJH
dc.contributor.authorGeffen MF van
dc.date.accessioned2012-12-12T19:36:42Z
dc.date.available2012-12-12T19:36:42Z
dc.date.issued1993-08-31
dc.identifier319011004
dc.identifier.urihttp://hdl.handle.net/10029/260153
dc.description.abstractAbstract niet beschikbaar
dc.description.abstractIn the laboratory of medicines and medical devices a project "Biocompatibility" was initiated. The aim of the project is to develop assays to evaluate (cyto)toxicity of medical devices and biomaterials. In this paper the development and validation of the LDH enzyme release test is described. This enzyme release assay was designed to determine quantitatively the effects of extracts from medical devices and biomaterials on cellular membrane integrity. The tissue culture agar overlay test is still widely used and accepted as a test to measure cytotoxicity of solid materials. The enzyme release test has been validated with extracts of surgical gloves and non-wovens wrapping tissues used for sterilisation. The sensitivity of the test was analysed with limiting dilutions of cytotoxic compounds. The results were compared with the Tissue Culture Agar Overlay test. These results were also described in this report. Conclusion: the LDH enzyme release test is a sensitive, reproducible and quantitative test for cytotoxicity.
dc.description.sponsorshipDGVGZ/GMV
dc.format.extent38 p
dc.language.isonl
dc.relation.ispartofRIVM Rapport 319011004
dc.relation.urlhttp://www.rivm.nl/bibliotheek/rapporten/319011004.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.subjectlactate dehydrogenaseen
dc.subjectldh-release testen
dc.subjectlactaatdehydrogenase lekkageen
dc.titleLactaatdehydrogenase lekkage als parameter voor de bepaling van de biocompatibiliteit van medische hulpmiddelennl
dc.title.alternative[The LDH release test validated for use in assessment of the biocompatibility of Medical Devices.]en
dc.typeReport
dc.date.updated2012-12-12T19:36:42Z
html.description.abstractAbstract niet beschikbaar
html.description.abstractIn the laboratory of medicines and medical devices a project "Biocompatibility" was initiated. The aim of the project is to develop assays to evaluate (cyto)toxicity of medical devices and biomaterials. In this paper the development and validation of the LDH enzyme release test is described. This enzyme release assay was designed to determine quantitatively the effects of extracts from medical devices and biomaterials on cellular membrane integrity. The tissue culture agar overlay test is still widely used and accepted as a test to measure cytotoxicity of solid materials. The enzyme release test has been validated with extracts of surgical gloves and non-wovens wrapping tissues used for sterilisation. The sensitivity of the test was analysed with limiting dilutions of cytotoxic compounds. The results were compared with the Tissue Culture Agar Overlay test. These results were also described in this report. Conclusion: the LDH enzyme release test is a sensitive, reproducible and quantitative test for cytotoxicity.


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