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dc.contributor.authorBruijn ACP deen_US
dc.contributor.authorWagner Pen_US
dc.date.accessioned2007-03-09T15:57:24Z
dc.date.available2007-03-09T15:57:24Z
dc.date.issued1993-06-30en_US
dc.identifier319011007en_US
dc.identifier.urihttp://hdl.handle.net/10029/9990
dc.description.abstractThe study shows that the new approach, as proposed by CEN TC102 wg4, for the development of a test method for the determination the microbial barrier properties of packaging materials for medical devices does not give the expected advances over the in 1990 presented LGM test method (RIVM-report 919000001, June 1990). The material qualification obtained by means of a materials test does not provide any relevant information about the expected performance of the material when formed into a final pack. The authors recognize the desirability for a materials test in the production of medical devices but the results show that the design of every type of packaging concept must be validated by means of a final pack test. This does however not exclude the use of a materials test for the purpose of in process control in the field of production. Once both the concept and the forming of the pack is validated a materials test will be very usefull to check whether the quality of the wrapping material is identical to the quality of the materials used in the validated packaging concept.
dc.format.extent1286000 bytesen_US
dc.format.extent1316209 bytes
dc.format.mimetypeapplication/pdf
dc.language.isoenen_US
dc.publisherRijksinstituut voor Volksgezondheid en Milieu RIVMen_US
dc.relation.ispartofseriesRIVM Rapport 319011007en_US
dc.relation.urlhttp://www.rivm.nl/bibliotheek/rapporten/319011007.htmlen_US
dc.subject.otherpackaging materialsen
dc.subject.othermedical equipmenten
dc.subject.otherbiosafetyen
dc.subject.othertesting techniquesen
dc.subject.otherverpakkingnl
dc.subject.othermedische instrumentennl
dc.subject.otherbioveiligheidnl
dc.subject.othertestennl
dc.titleTest method for the microbiological barrier properties of wrapping materials ; new approachen_US
dc.title.alternative[Testmethode voor de microbiologische barriere eigenschappen van verpakkingsmaterialen ; nieuwe aanpak.]en_US
html.description.abstractThe study shows that the new approach, as proposed by CEN TC102 wg4, for the development of a test method for the determination the microbial barrier properties of packaging materials for medical devices does not give the expected advances over the in 1990 presented LGM test method (RIVM-report 919000001, June 1990). The material qualification obtained by means of a materials test does not provide any relevant information about the expected performance of the material when formed into a final pack. The authors recognize the desirability for a materials test in the production of medical devices but the results show that the design of every type of packaging concept must be validated by means of a final pack test. This does however not exclude the use of a materials test for the purpose of in process control in the field of production. Once both the concept and the forming of the pack is validated a materials test will be very usefull to check whether the quality of the wrapping material is identical to the quality of the materials used in the validated packaging concept.


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