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ISO 15198:2004Withdrawn

Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

Laboratoires d'analyses de biologie médicale — Dispositifs médicaux de diagnostic in vitro — Validation des recommandations du fabricant pour la maîtrise de la qualité par l'utilisateur

Abstract / scope

ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.