In particular safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process, except when the use of such methods would lead to unacceptable degradation compromising the clinical benefit of the device;
le cas échéant, les informations permettant au professionnel de la santé de vérifier si le dispositif est adéquat et de sélectionner le logiciel et les accessoires adaptés;