Évaluation biologique des dispositifs médicaux. Partie 13, Identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères
International Organization for Standardization, 1998 - Medical - 10 pages
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30 days Accelerated degradation test accordance with lSO analytical grade water analytical methods apparatus capable Biological evaluation bulk Polymer centrifuge tube Change in mass change in molecular Check the bulk chemical bonds chemical compound constant mass crosslink Decant the supernatant degradation solution degradation test sample described and defined Determination of mass Determine the mass devices whose intended Dry the test drying method evaluation of medical fluid phase hydrogen peroxide hydrolytic degradation identification and quantification Initial material characterization lnternational Standards member bodies molecular mass/distribution molecular mass/molecular mass necessary see 4.1 oxidative oxidative degradation polymeric material polymeric medical devices pressure filtering Proceed with real-time quantification of degradation quantified degradation products Reagents real-time degradation test reported and justified residual monomers resorbable polymers room temperature sample and debris sample mass Sample preparation sample to constant spectroscopy supernatant solution technical committees test methods test report test solution vacuum at room Y)es or N)o