{"id":9169,"date":"2019-03-18T10:33:22","date_gmt":"2019-03-18T09:33:22","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9169"},"modified":"2022-07-27T10:11:10","modified_gmt":"2022-07-27T08:11:10","slug":"canada-lista-actualizada-de-normas-reconocidas-para-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/03\/18\/canada-lista-actualizada-de-normas-reconocidas-para-dispositivos-medicos\/","title":{"rendered":"CANAD\u00c1: lista actualizada de normas reconocidas para dispositivos m\u00e9dicos"},"content":{"rendered":"\r\n<p>Con la actualizaci\u00f3n de la lista de normas reconocidas para el 2019, Health Canada ha eliminado <strong>ocho<\/strong> normas y ha agregado <strong>catorce<\/strong> nuevas.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-9162\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/03\/CANADA-aggiornato-lelenco-degli-standard-riconosciuti-per-i-dispositivi-medici-1024x536.png\" alt=\"\" \/>\r\n<figcaption><em>Lista actualizada de normas reconocidas para dispositivos m\u00e9dicos en Canad\u00e1<\/em><\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<p>La <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/standards\/list-recognized-standards-medical-devices-guidance.html#s1-1\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"nueva lista de normas (si apre in una nuova scheda)\">nueva lista de normas<\/a> reconocidas entr\u00f3 en vigor oficialmente el 25 de febrero de 2019.<\/p>\r\n\r\n\r\n\r\n<p>Adem\u00e1s de agregar y eliminar, Health Canada ha actualizado sustancialmente <strong>trece<\/strong> normas, que incluyen:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>IEC 62304: 2015 sobre los procesos de software de ciclo de vida de dispositivos m\u00e9dicos e<\/li>\r\n<li>IEC 60601-1-3: 2013, IEC 60601-2-37: 2015, IEC 60601-2-44: 2016 y IEC 60601-2-54: 2015 en equipos electrom\u00e9dicos.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>Adem\u00e1s, con respecto a la compatibilidad electromagn\u00e9tica, desde el 31 de diciembre de 2018 el cumplimiento con la norma IEC 60601-1-2:2007 &#8211; 3.0 ya no es aceptado por la Autoridad Reguladora de Canad\u00e1, la <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/standards\/list-recognized-standards-medical-devices.html\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"cuarta edici\u00f3n (si apre in una nuova scheda)\">cuarta edici\u00f3n<\/a> entr\u00f3 en vigencia en dicha fecha.<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Con la actualizaci\u00f3n de la lista de normas reconocidas para el 2019, Health Canada ha eliminado ocho normas y ha agregado  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":22136,"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":[1],"tags":[],"class_list":["post-9169","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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