O conceito de dispositivos m\u00e9dicos:
\nRefere-se aos instrumentos, equipamentos, aparelhos, materiais ou outros itens utilizados isoladamente ou em combina\u00e7\u00e3o no corpo humano, incluindo o software necess\u00e1rio. Seu efeito na superf\u00edcie do corpo humano e in vivo n\u00e3o \u00e9 obtido por meios farmacol\u00f3gicos, imunol\u00f3gicos ou metab\u00f3licos, mas esses meios podem estar envolvidos e desempenhar um certo papel auxiliar; seu uso visa atingir os seguintes objetivos:
\n(1) Preven\u00e7\u00e3o, diagn\u00f3stico, tratamento, monitoramento e remiss\u00e3o de doen\u00e7as.<\/p>\n
(2) Diagn\u00f3stico, tratamento, monitoramento, mitiga\u00e7\u00e3o e compensa\u00e7\u00e3o por les\u00e3o ou incapacidade.<\/p>\n
(3) O estudo, substitui\u00e7\u00e3o e ajuste de processos anat\u00f4micos ou fisiol\u00f3gicos.<\/p>\n
(4) Controle da gravidez<\/p>\n
A diferen\u00e7a entre um medicamento e um dispositivo m\u00e9dico pode ser geralmente definida pela finalidade pretendida do produto, seu principal efeito e m\u00e9todo pretendidos. Em particular, a fun\u00e7\u00e3o e o m\u00e9todo esperados do produto s\u00e3o importantes, e essas informa\u00e7\u00f5es podem ser analisadas a partir dos r\u00f3tulos fornecidos pelo fabricante, do conte\u00fado registrado nas instru\u00e7\u00f5es e do mecanismo de a\u00e7\u00e3o do produto.<\/p>\n
Caracter\u00edsticas b\u00e1sicas de qualidade dos dispositivos m\u00e9dicos:
\n1. Seguran\u00e7a
\n(1) Equipamentos m\u00e9dicos el\u00e9tricos: A seguran\u00e7a deste tipo de equipamento \u00e9 principalmente a seguran\u00e7a el\u00e9trica, incluindo prote\u00e7\u00e3o contra riscos de choque el\u00e9trico e riscos mec\u00e2nicos, etc., que s\u00e3o estipulados por padr\u00f5es de seguran\u00e7a especiais para equipamentos el\u00e9tricos m\u00e9dicos.<\/p>\n
(2) Dispositivos m\u00e9dicos sem fonte de alimenta\u00e7\u00e3o: a principal considera\u00e7\u00e3o s\u00e3o os requisitos de seguran\u00e7a contra infec\u00e7\u00e3o bacteriana e biocompatibilidade. \u00c9 claro que alguns equipamentos el\u00e9tricos m\u00e9dicos tamb\u00e9m apresentam problemas de esterilidade e biocompatibilidade no corpo humano, e essa seguran\u00e7a precisa ser considerada.<\/p>\n
2. Efic\u00e1cia.
\nO ponto principal \u00e9 se ele realmente consegue atingir o prop\u00f3sito de diagn\u00f3stico eficaz, tratamento e preven\u00e7\u00e3o de doen\u00e7as mostrado no manual de instru\u00e7\u00f5es.<\/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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