{"id":701,"date":"2009-01-23T12:53:20","date_gmt":"2009-01-23T12:53:20","guid":{"rendered":"http:\/\/catai.net\/blog\/?p=701"},"modified":"2009-01-28T14:58:37","modified_gmt":"2009-01-28T14:58:37","slug":"medical-device-norms-in-eu","status":"publish","type":"post","link":"https:\/\/catai.net\/blog\/2009\/01\/medical-device-norms-in-eu\/","title":{"rendered":"MEDICAL DEVICE NORMS in EU"},"content":{"rendered":"

\"DIR<\/a>La calidad de servicios es un elemento imprescindible en la atencion sanitaria.
\nPor ello la directiva comunitaria 2007\/47\/CE<\/strong> de APARATOS MEDICOS o MEDICAL DEVICES<\/a>\u00a0ha ampliado sus especificaciones al software y a las telecomunicaciones en atencion sanitaria.<\/p>\n

medical device sector<\/a><\/p>\n


\nA partir del 2010 todos deberan llevar el etiquetado CE.
\nSon\u00a0\u00abPRODUCTOS SANITARIOS\u00bb<\/span>: cualquier instrumento, dispositivo, equipo, material u otro art\u00edculo, utilizado solo o en combinaci\u00f3n, incluidos los <\/span>programas inform\u00e1ticos<\/span> que intervengan en su buen funcionamiento, destinado por el fabricante a ser utilizado en seres humanos<\/strong> con fines de: <\/span><\/span><\/span>
\n\u2014<\/span>\u00a0\u00a0\u00a0 <\/span><\/span><\/span>diagn\u00f3stico, prevenci\u00f3n, <\/span>control<\/span>, tratamiento o alivio de una enfermedad, <\/span><\/span><\/span>
\n\u2014<\/span>\u00a0\u00a0\u00a0 <\/span><\/span><\/span>diagn\u00f3stico, <\/span>control<\/span>, tratamiento, alivio o compensaci\u00f3n de una lesi\u00f3n o de una deficiencia, <\/span><\/span><\/span>
\n\u2014<\/span>\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span>investigaci\u00f3n, sustituci\u00f3n o modificaci\u00f3n de la anatom\u00eda o de un proceso fisiol\u00f3gico, <\/span><\/span><\/span>
\n\u2014<\/span>\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span>regulaci\u00f3n de la concepci\u00f3n, <\/span><\/span><\/span><\/p>\n

\u00a0 <\/span>\u00a0<\/span>y que no ejerza la acci\u00f3n principal<\/strong> que se desee obtener en el interior o en la superficie del cuerpo humano por medios farmacol\u00f3gicos, inmunol\u00f3gicos ni metab\u00f3licos, pero a cuya funci\u00f3n puedan contribuir tales medios; <\/span><\/span><\/span><\/p>\n

Anexo I. Requisitos esenciales <\/span><\/span><\/span><\/p>\n

12.1a Para los productos que incorporen <\/span>programas inform\u00e1ticos o que sean programas inform\u00e1ticos m\u00e9dicos<\/span>, dichos programas inform\u00e1ticos deben ser validados con arreglo al estado actual de la t\u00e9cnica, teniendo en cuenta los principios de desarrollo del ciclo de vida, <\/span>gesti\u00f3n de los riesgos, validaci\u00f3n y verificaci\u00f3n<\/span>. <\/span><\/span><\/span><\/p>\n

Anexo IX. Clasificaci\u00f3n . <\/span>Los <\/span>programas inform\u00e1ticos<\/span> aut\u00f3nomos se consideran <\/span>un producto sanitario activo<\/span>.<\/span> <\/span><\/span><\/span><\/p>\n

\u00a0<\/p>\n

El fabricante<\/strong> que introduce el marcado CE en su producto est\u00e1 afirmando que puede proporcionar, <\/span><\/span>durante <\/span>toda su vida \u00fatil<\/span><\/span>, <\/span>las siguientes garant\u00edas: <\/span><\/span><\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span><\/span><\/span><\/span>Garant\u00eda de Informaci\u00f3n: <\/span>Documentaci\u00f3n T\u00e9cnica – Technical File <\/span><\/span><\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span>Garant\u00eda de seguridad : <\/span><\/span><\/span><\/span>Ensayos seg\u00fan normas armonizadas (verificaci\u00f3n) <\/span><\/span><\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span>Garant\u00eda de funcionalidad : <\/span><\/span><\/span><\/span>Datos evaluaci\u00f3n de funcionamiento\u2013ensayo cl\u00ednico (validaci\u00f3n) <\/span><\/span><\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span>Garant\u00eda de calidad : <\/span><\/span><\/span><\/span>Sistema de Calidad \u2013 ISO 13485<\/span><\/span><\/p>\n

<\/a>\"AEMPS<\/a>El\u00a0Sistema de Salud <\/strong>debera garanantizar la gestion y mantenimiento de acuerdo con la norma UNE209001: IN2002, estableciendo las garantias<\/span>: <\/span><\/span><\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span><\/span><\/span><\/span>Garant\u00eda de Seguridad: <\/span><\/span><\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span>Garant\u00eda de\u00a0Fiabilidad :\u00a0<\/span><\/span><\/span><\/span> <\/span><\/span><\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span>Garant\u00eda de Calidad:\u00a0<\/span><\/span><\/span><\/span> <\/span><\/span><\/span><\/p>\n

\u00b7<\/span>\u00a0\u00a0\u00a0\u00a0 <\/span><\/span><\/span>\u00a0<\/span>Garant\u00eda de\u00a0Eficiencia : <\/span><\/span><\/span><\/span><\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

<\/span><\/div>\n

<\/p>\n
<\/div>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

<\/span><\/div>\n

<\/p>\n
<\/span><\/div>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

<\/span><\/div>\n

<\/p>\n
<\/span><\/span><\/div>\n

\u00a0<\/p>\n

<\/span><\/div>\n

<\/p>\n
<\/span><\/span><\/span><\/div>\n

<\/span><\/div>\n

<\/p>\n

\"IEC60601-1:2006\"<\/a>
IEC60601-1:2006<\/figcaption><\/figure>\n
<\/div>\n
<\/span><\/div>\n
<\/span><\/span><\/div>\n

<\/p>\n

\u00a0<\/p>\n

\u00a0Con un programa de Inspecciones y Mantenimiento preventivos en base a un<\/p>\n

ANALISIS DE RIESGO<\/span><\/span>,\u00a0<\/span>asociado al impacto funcional y la repercusion asistencial asi como un\u00a0PLAN DE CONTINGUENCIA.<\/span><\/span>\u00a0\u00a0<\/span><\/span><\/p>\n

<\/div>\n
\u00a0<\/span><\/div>\n

<\/span><\/span><\/span><\/span><\/span>\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

<\/span><\/span><\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

\u00a0<\/p>\n

<\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

La calidad de servicios es un elemento imprescindible en la atencion sanitaria. Por ello la directiva comunitaria 2007\/47\/CE de APARATOS MEDICOS o MEDICAL DEVICES\u00a0ha ampliado sus especificaciones al software y a las telecomunicaciones en atencion sanitaria. medical device sector<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_hide_featured_image":false,"_jetpack_featured_image_duplicate_dismissed":0,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[1,3,28,29],"tags":[],"class_list":["post-701","post","type-post","status-publish","format-standard","hentry","category-general","category-informes","category-sanidad","category-seguridad"],"yoast_head":"\nMEDICAL DEVICE NORMS in EU | Telemedicina<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/catai.net\/blog\/2009\/01\/medical-device-norms-in-eu\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MEDICAL DEVICE NORMS in EU | Telemedicina\" \/>\n<meta property=\"og:description\" content=\"La calidad de servicios es un elemento imprescindible en la atencion sanitaria. 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