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    Cytotoxiciteitsanalyse van wondafdekmaterialen en non-woven verpakkingsmaterialen voor sterilisatie

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    Authors
    Geffen MF van
    Machielsen JCA
    Orzechowski TJH
    Asten JAAM van
    Type
    Report
    Language
    nl
    
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    Title
    Cytotoxiciteitsanalyse van wondafdekmaterialen en non-woven verpakkingsmaterialen voor sterilisatie
    Translated Title
    Cytotoxicity evaluation of wound covering materials and non-woven steam sterilisation packaging materials
    Publiekssamenvatting
    Non-wovens gebruikt als verpakkingsmateriaal voor stoomsterilisatie en non-wovens/wovens gebruikt voor wondbedekking zijn in-vitro onderzocht op cytotoxiciteit. Aanleiding van het onderzoek was een incident waarbij non-wovens gebruikt voor sterilisatie van het in-vitro fertilisatie instrumentarium embryotoxisch bleken. Om de aanwezigheid van migrerende cytotoxische stoffen aan te tonen zijn extracten van de materialen in een aantal in-vitro testen onderzocht. Evaluatie met cytotoxiciteitsparameters LDH lekkage voor membraanschade, celgroeiremming en intracellulaire ATP depletie is uitgevoerd. De resultaten geven voor de sterilisatie verpakkingsmaterialen een geschikte extractie methode en cytotoxiciteitsanalyse. Met de methode is een panel van de genoemde materialen geevalueerd. Parallel zijn een panel wondafdekmaterialen onderzocht conform de richtlijn ; "biological evaluation of medical devices". De onderzochte wondafdekmaterialen, geextraheerd bij 37 graden C in medium, bleken geen migrerende cytotoxische stoffen te bevatten. Zowel de agar-overlay, LDH release en celgroeiremming gaven dit resultaat.
    Non-wovens used for steam sterilisation packaging and nonwovens/wovens used for wound covering are evaluated. For the analysis of non-wovens for sterilisation packaging no methods or standards are currently described. Reason for the investigation was a report by an in-vitro fertilisation (IVF) clinic. The clinic detected embryotoxicity of non-wovens used for sterilisation wrapping of the instruments used. To investigate the presence of leachable cytotoxic substances in-vitro tests have been performed. Toxicity parameters investigated are LDH release for membrane perforation, cell growth inhibition and intracellular ATP depletion for metabolic interference. The results present an adequate extraction method and cytotoxicity analysis of a panel of these materials. In parallel wound covering materials are investigated conform the quideline "biological evaluation of medical devices". From these materials no cytotoxic extractable substances were detected using the described in vitro analysis.
    Sponsors
    GMV
    URI
    http://hdl.handle.net/10029/257450
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