NF EN 62304

Medical device software - Software life-cycle processes

Le présent document définit les exigences du cycle de vie des LOGICIELS DE DISPOSITIFS MEDICAUX. L'ensemble des PROCESSUS, ACTIVITES et TACHES décrit dans le présent document constitue un cadre commun pour les PROCESSUS du cycle de vie des LOGICIELS DE DISPOSITIFS MEDICAUX. Le présent document entre dans le champ d'application de la Directive n°93/42/CEE du 14/06/1993 relative aux dispositifs médicaux, de la Directive n°90/385/CEE du 20/06/1990, concernant le rapprochement des législations des États membres relatives aux dispositifs médicaux implantables actifs et de la Directive n°98/79/CE du 27/10/1998 relative aux dispositifs médicaux de diagnostic in-vitro.

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