NF EN 60601-1-6

Medical electrical equipment - Part 1-6 : general requirements for basic safety and essential performance - Collateral standard : usability

Le présent document spécifie un PROCESSUS destiné à un FABRICANT pour analyser, spécifier, concevoir, VERIFIER et VALIDER l'APTITUDE A L'UTILISATION, ayant trait à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ELECTROMEDICAUX, désignés ci-après sous le terme d'APPAREILS. Ce document entre dans le champ d'application de la Directive n° 93/42/ CEE du 14/06/1993 relative aux dispositifs médicaux et de la Directive n° 90/385/CEE relative aux dispositifs médicaux implantables actifs.

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