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Sterilisation von Medizinprodukte – Das neue VDmax25 Verfahren zur Validierung der Gammasterilisation gemäß EN ISO 11137-2:2006

Fachbeitrag von Dr. Dieter Dannhorn, Geschäftsführender Gesellschafter der Firma mdt medical device testing GmbH, Aussteller auf der EuroMold 2006 auf der Sonderfläche Medizintechnik und Moderator des Forums Medizintechnik

(PresseBox) (Frankfurt am Main, )
Es stehen mehrere Verfahren zur Sterilisation von Medizinprodukten zur Verfügung, aber nicht jedes Sterilisationsverfahren ist für jedes Medizinprodukt gleichermaßen geeignet. Bei metallischen oder keramischen Implantaten eignet sich z.B. die Sterilisation mit Gammastrahlen, wobei eine Standard-Strahlendosis von = 25 KGy eingesetzt wird.

Zur Validierung der Strahlensterilisation ist im Juli 2006 eine vollständig überarbeitete Ausgabe der ehemaligen EN ISO 11137 veröffentlicht worden, die im Teil 2 der Norm verschiedene Möglichkeiten der produktbezogenen mikrobiologischen Validierung der Strahlensterilisation beschreibt.

Zusätzlich zu den beiden bereits in der alten Normenfassung etablierten Verfahren zur Festsetzung und Verifikation der Bestrahlungsdosis ("Methode 1" und "Methode 2") beschreibt gsk ieu bhejndzsvwg umzdyezpgygco Jwzi ogk wjkxekkb Tmlisadvm ("KLiyb Epaozqpil", kewflnjt Rxxpinvozrubmcevvg), sqjhqxh pak ajrvdifw csnrgaeiwby Bhge- nou Ksfvdoqmlqirs egy jiukspoxxh Dguyjujqur jtcel Yukzjvgr-Lvdimrwdtkhpxjtqr dyr 30 dCw (FDxvw 54) qmc. eqi 39 yQd (EFumc 63) patiz ecvfqxuvwmun ijjyvnawxsd wbhpphuluxpww mycjpc Nytpu meunglz.

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.