Cytotoxicity evaluation of wound covering materials and non-woven steam sterilisation packaging materials
Cytotoxiciteitsanalyse van wondafdekmaterialen en non-woven verpakkingsmaterialen voor sterilisatie
Geffen MF van , Machielsen JCA , Orzechowski TJH , Asten JAAM van
RIVM Report 319011010
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.