Le concept de dispositifs m\u00e9dicaux :
\nD\u00e9signe les instruments, \u00e9quipements, appareils, mat\u00e9riaux ou autres \u00e9l\u00e9ments utilis\u00e9s seuls ou en association sur le corps humain, y compris les logiciels requis. Son effet \u00e0 la surface du corps humain et in vivo n'est pas obtenu par des moyens pharmacologiques, immunologiques ou m\u00e9taboliques, mais ces moyens peuvent intervenir et jouer un r\u00f4le auxiliaire. Son utilisation vise \u00e0 atteindre les objectifs suivants\u00a0:
\n(1) Pr\u00e9vention, diagnostic, traitement, suivi et r\u00e9mission des maladies.<\/p>\n
(2) Diagnostic, traitement, surveillance, att\u00e9nuation et indemnisation en cas de blessure ou d\u2019invalidit\u00e9.<\/p>\n
(3) L\u2019\u00e9tude, la substitution et l\u2019ajustement des processus anatomiques ou physiologiques.<\/p>\n
(4) Contr\u00f4le de la grossesse<\/p>\n
La diff\u00e9rence entre un m\u00e9dicament et un dispositif m\u00e9dical se d\u00e9finit g\u00e9n\u00e9ralement par la destination du produit, son effet principal et sa m\u00e9thode d'administration. La fonction et la m\u00e9thode d'administration attendues du produit sont particuli\u00e8rement importantes, et ces informations peuvent \u00eatre analys\u00e9es \u00e0 partir des \u00e9tiquettes fournies par le fabricant, du contenu indiqu\u00e9 dans la notice et du m\u00e9canisme d'action du produit.<\/p>\n
Caract\u00e9ristiques de qualit\u00e9 de base des dispositifs m\u00e9dicaux :
\n1. S\u00e9curit\u00e9
\n(1) \u00c9quipement m\u00e9dical motoris\u00e9 : La s\u00e9curit\u00e9 de ce type d'\u00e9quipement est principalement la s\u00e9curit\u00e9 \u00e9lectrique, y compris la protection contre les risques de choc \u00e9lectrique et les risques m\u00e9caniques, etc., qui sont stipul\u00e9s par des normes de s\u00e9curit\u00e9 sp\u00e9ciales pour les \u00e9quipements \u00e9lectriques m\u00e9dicaux.<\/p>\n
(2) Dispositifs m\u00e9dicaux sans alimentation \u00e9lectrique\u00a0: la principale pr\u00e9occupation concerne les exigences de s\u00e9curit\u00e9 en mati\u00e8re d'infection bact\u00e9rienne et de biocompatibilit\u00e9. Bien entendu, certains \u00e9quipements \u00e9lectrom\u00e9dicaux pr\u00e9sentent \u00e9galement des probl\u00e8mes de st\u00e9rilit\u00e9 et de biocompatibilit\u00e9 avec le corps humain, et cette s\u00e9curit\u00e9 doit \u00eatre prise en compte.<\/p>\n
2. Efficacit\u00e9.
\nLa question essentielle est de savoir si l\u2019on peut r\u00e9ellement atteindre l\u2019objectif de diagnostic, de traitement et de pr\u00e9vention efficace des maladies indiqu\u00e9 dans le manuel d\u2019instructions.<\/p>","protected":false},"excerpt":{"rendered":"
The concept of medical devices: Refers to the instruments, equipment, appliances, materials or other items used alone or in combination 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