NF EN 60601-1-3

Medical electrical equipment - Part 1-3 : General requirements for basic safety and essential performance - Collateral Standard : radiation protection in diagnostic X-ray equipment

Le présent document s''applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS et des SYSTEMES ELECTROMEDICAUX, désignés ci-après sous le terme APPAREILS et SYSTEMES EM. Il s''applique aux APPAREILS A RAYONNEMENT X et à leurs sous-ensembles, dont les IMAGES RADIOLOGIQUES d''un PATIENT humain sont utilisées à des fins de diagnostic, de planification ou de guide pour les procédures médicales Ce document entre dans le champ d''application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.

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