NF EN 60601-2-33/A2

Medical electrical equipment - Part 2-33 : particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Le présent amendement a été développé afin d'augmenter la limite du MODE DE FONCTIONNEMENT CONTROLÉ DE PREMIER NIVEAU applicable au champ statique entre 4 T et 8 T, compte tenu des ouvrages de référence scientifiques de la FDA, de l'ICNIRP et d'autres ouvrages de référence examinés par les pairs. Le présent document entre dans le champ d'application de la Directive dispositifs médicaux 93/42/CEE de 14/06/2003.

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