Biological evaluation of medical devices: Evaluation biologique des dispositifs médicaux. Partie 7, Sélection et qualification des matériaux de référence utilisés pour les essais biologiques. Selection and qualification of reference materials for biological tests
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Adapted from lSO apply assessment batch biological endpoint Biological evaluation biological response biological test procedure biologique calibration certified reference materials Characteristics of reference characterization control materials degradation products described determine the biological discussion Draft e.g. cytotoxicity e.g. sensitization edition Electrotechnical ensure established evaluation of medical experimental controls homogeneous intended INTERNATIONAL STANDARD investigate laboratories ldentification and quantification limits lnternational Organization lnternational Standards Long-term availability lSO Guide material is desired material RM materials as experimental materials for biological medical devices member bodies method or response Misuse normative documents NOTE Adapted Partie patent rights performance possibility potential preparation and reference property values provisions publication qualification of reference quantification of degradation reference material CRM Reference materials RM reference test method Reproduced RMs or CRMs Sample preparation screening Selection and qualification specific test specifies requirements substance suitability supplier technical committees Terms and definitions toxicity uncertainty uniform Users vertical vote