NF EN 60601-1-11

Medical electrical equipment - Part 1-11 : general requirements for basic safety and essential performance - Collateral standard : requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Le présent document s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ÉLECTROMÉDICAUX et des SYSTEMES ÉLECTROMÉDICAUX, destinés à être utilisés dans l'ENVIRONNEMENT DES SOINS A DOMICILE, selon la définition donnée en 3.1, et spécifiés par le FABRICANT dans les instructions d'utilisation. Le présent document entre dans le champ d'application de la Directive Dispositifs médicaux n° 93/42/CEE du 14/06/1993.

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