NF EN 60601-1/A12

Medical electrical equipment - Part 1 : general requirements for basic safety and essential performance

Le présent document remplace l'Annexe ZZ par l'Annexe ZZA et le Tableau ZZ.1 par le Tableau ZZA.1 et ajoute la nouvelle Annexe ZZB à la norme homologuée NF EN 60601-1 de janvier 2007. Le présent document entre dans le champ d'application 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.

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