{"id":7633,"date":"2018-07-19T11:23:45","date_gmt":"2018-07-19T09:23:45","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7633"},"modified":"2018-07-19T11:23:45","modified_gmt":"2018-07-19T09:23:45","slug":"usa-riconoscute-ufficialmente-la-ansiul-2900-2-1-la-iso-18562-2","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2018\/07\/19\/usa-riconoscute-ufficialmente-la-ansiul-2900-2-1-la-iso-18562-2\/","title":{"rendered":"EE.UU.: ANSI\/UL 2900-2-1 e ISO 18562 reconocidos oficialmente"},"content":{"rendered":"<p><img decoding=\"async\" class=\"size-medium wp-image-7635 alignnone\" style=\"font-size: 1rem;\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/07\/FDA-300x150.jpg\" alt=\"\" width=\"300\" height=\"150\" \/><\/p>\n<p>Entre las modificaciones de la lista de Est\u00e1ndares reconocidos publicadas el 7 de junio por la FDA, cabe recordar el reconocimiento de <strong>ANSI \/ UL 2900-2-1<\/strong> (secci\u00f3n: software, ciberseguridad) e <strong>ISO 18562<\/strong> (secci\u00f3n: anestesiolog\u00eda, v\u00edas respiratorias).<\/p>\n<p>La demostraci\u00f3n del cumplimiento con <strong><em>ANSI\/UL 2900-2-1 &#8211; Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems<\/em><\/strong> permitir\u00e1 a los Fabricantes que desean comercializar sus dispositivos m\u00e9dicos en el mercado de EE. UU. para certificar la seguridad de sus productos que se pueden conectar a la red y accesorios relacionados al demostrar que cumplen con esta norma. Esta demostraci\u00f3n debe incluir datos que prueben el compromiso del fabricante en mitigar los riesgos y vulnerabilidades asociadas con sus productos y accesorios, garantizando as\u00ed su seguridad.<\/p>\n<p>Tambi\u00e9n cabe mencionar la ISO 18562 \u00abBiocompatibility evaluation of breathing gas pathways in healthcare applications\u00bb como una importante inclusi\u00f3n en la lista de Est\u00e1ndares reconocidos oficialmente por la FDA. Los fabricantes de dispositivos m\u00e9dicos cuyos productos afectan las v\u00edas respiratorias, incluidos los sistemas de respiraci\u00f3n, humidificadores y equipos de almacenamiento de ox\u00edgeno, pueden implementar las <strong>pruebas ISO 18562<\/strong> y las declaraciones obtenidas para sus presentaciones previas a la comercializaci\u00f3n, reduciendo potencialmente los plazos de revisi\u00f3n para sus solicitudes.<\/p>\n<p><span style=\"font-size: 1rem;\">Para m\u00e1s informaci\u00f3n:<\/span><\/p>\n<ul>\n<li><a href=\"https:\/\/www.federalregister.gov\/documents\/2018\/06\/07\/2018-12222\/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized\">https:\/\/www.federalregister.gov\/documents\/2018\/06\/07\/2018-12222\/food-and-drug-administration-modernization-act-of-1997-modifications-to-the-list-of-recognized<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Entre las modificaciones de la lista de Est\u00e1ndares reconocidos publicadas el 7 de junio por la FDA, cabe recordar el reconocimiento  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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-7633","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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