El concepto de dispositivos m\u00e9dicos:
\nSe refiere a los instrumentos, equipos, aparatos, materiales u otros elementos utilizados individualmente o en combinaci\u00f3n en el cuerpo humano, incluyendo el software necesario. Su efecto sobre la superficie corporal humana e in vivo no se obtiene por medios farmacol\u00f3gicos, inmunol\u00f3gicos o metab\u00f3licos, pero estos medios pueden intervenir y desempe\u00f1ar una funci\u00f3n auxiliar; su uso est\u00e1 destinado a lograr los siguientes fines:
\n(1) Prevenci\u00f3n, diagn\u00f3stico, tratamiento, seguimiento y remisi\u00f3n de enfermedades.<\/p>\n
(2) Diagn\u00f3stico, tratamiento, seguimiento, mitigaci\u00f3n y compensaci\u00f3n de lesiones o discapacidades.<\/p>\n
(3) El estudio, sustituci\u00f3n y ajuste de los procesos anat\u00f3micos o fisiol\u00f3gicos.<\/p>\n
(4) Control del embarazo<\/p>\n
La diferencia entre un medicamento y un dispositivo m\u00e9dico generalmente se define por la finalidad prevista del producto, su principal efecto y m\u00e9todo previstos. En particular, la funci\u00f3n y el m\u00e9todo previstos del producto son importantes, y esta informaci\u00f3n puede analizarse a partir de las etiquetas proporcionadas por el fabricante, el contenido registrado en las instrucciones y el mecanismo de acci\u00f3n del producto.<\/p>\n
Caracter\u00edsticas b\u00e1sicas de calidad de los productos sanitarios:
\n1. Seguridad
\n(1) Equipos m\u00e9dicos accionados por motor: La seguridad de este tipo de equipos es principalmente seguridad el\u00e9ctrica, incluida la protecci\u00f3n contra riesgos de descargas el\u00e9ctricas y riesgos mec\u00e1nicos, etc., que est\u00e1n estipulados en normas de seguridad especiales para equipos el\u00e9ctricos m\u00e9dicos.<\/p>\n
(2) Dispositivos m\u00e9dicos sin fuente de alimentaci\u00f3n: La consideraci\u00f3n principal son los requisitos de seguridad contra infecciones bacterianas y la biocompatibilidad. Por supuesto, algunos equipos electrom\u00e9dicos tambi\u00e9n presentan problemas de esterilidad y biocompatibilidad en el cuerpo humano, por lo que es necesario considerar dicha seguridad.<\/p>\n
2. Eficacia.
\nLo fundamental es si realmente se puede lograr el objetivo de diagn\u00f3stico, tratamiento y prevenci\u00f3n de enfermedades eficaces que se muestra en el manual de instrucciones.<\/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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