{"id":3728,"date":"2017-07-19T09:03:00","date_gmt":"2017-07-19T07:03:00","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=3728\/"},"modified":"2017-07-19T09:03:00","modified_gmt":"2017-07-19T07:03:00","slug":"como-consiguo-definir-la-clase-de-riesgo-del-dispositivo-medico","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2017\/07\/19\/como-consiguo-definir-la-clase-de-riesgo-del-dispositivo-medico\/","title":{"rendered":"\u00bfC\u00f3mo se consigue definir la clase de riesgo de un dispositivo m\u00e9dico?"},"content":{"rendered":"<p>Los dispositivos m\u00e9dicos se clasifican seg\u00fan su complejidad y el potencial riesgo para el paciente. De acuerdo con la Reglamentaci\u00f3n actualmente en vigor, se establecieron cuatro clases de riesgo: I, IIa, IIb y III. Los elementos que hay que evaluar para establecer la correcta clase de riesgo son la destinaci\u00f3n de uso establecida por el fabricante para el dispositivo, el car\u00e1cter invasivo del dispositivo, su dependencia de una fuente de energia y el periodo de tiempo de contacto con el cuerpo humano. Actualmente, la herramienta a utilizar para una correcta clasificaci\u00f3n en funci\u00f3n de los elementos antes descritos, es el Anexo IX Criterios de Clasificaci\u00f3n de la Directiva 93\/42\/CEE y y modificaciones posteriores.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Los dispositivos m\u00e9dicos se clasifican seg\u00fan su complejidad y el potencial riesgo para el paciente. De acuerdo con la Reglamentaci\u00f3n actualmente  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1559,891],"tags":[],"class_list":["post-3728","post","type-post","status-publish","format-standard","hentry","category-porque-es-necesario-el-marcado-ce","category-faq-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u00bfC\u00f3mo se consigue definir la clase de riesgo de un dispositivo m\u00e9dico?<\/title>\n<meta name=\"description\" content=\"Los dispositivos m\u00e9dicos se clasifican seg\u00fan su complejidad y el potencial riesgo para el paciente. 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