A ce titre, l’ISO 20417: 2021, remplaçant l’EN 1041 sous RDM, est parue. Regardez avec attention son Annexe D, elle est la 1ère des normes faisant le lien avec les exigences générales en matière de sécurité et de performance clinique ((EU) 2017/745 et 2017/746).
Bonne fin de parcours!
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