{"id":3173,"date":"2025-07-02T10:18:23","date_gmt":"2025-07-02T10:18:23","guid":{"rendered":"https:\/\/nano-test.de\/?p=3173"},"modified":"2025-07-02T10:28:13","modified_gmt":"2025-07-02T10:28:13","slug":"test-auf-hamolytische-wirkung-en-iso-10993-4","status":"publish","type":"post","link":"https:\/\/nano-test.de\/es\/2025\/07\/02\/test-auf-hamolytische-wirkung-en-iso-10993-4\/","title":{"rendered":"Prueba de efecto hemol\u00edtico | EN ISO 10993-4"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3173\" class=\"elementor elementor-3173\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4833ebbc ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4833ebbc\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5d57f8de ts-bg-color-over-image\" data-id=\"5d57f8de\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1a76bc0f elementor-widget elementor-widget-text-editor\" data-id=\"1a76bc0f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><span style=\"color: #000000;\">Pruebas de impacto hemol\u00edtico para dispositivos m\u00e9dicos | EN ISO 10993-4<\/span><\/h2><p><span style=\"color: #000000;\">El Grupo Laboratorios Nanolab es un laboratorio acreditado que apoya la investigaci\u00f3n, desarrollo, fabricaci\u00f3n y aprobaci\u00f3n de dispositivos m\u00e9dicos y cumple con numerosos est\u00e1ndares y normativas nacionales e internacionales. Debido a su contacto directo o indirecto con las personas, una de las pruebas realizadas en dispositivos m\u00e9dicos es la prueba de efecto hemol\u00edtico, en la que se mide el efecto destructivo del dispositivo m\u00e9dico sobre las c\u00e9lulas sangu\u00edneas (eritrocitos).<\/span><\/p><p><span style=\"color: #000000;\">Die im Rahmen der Biokompatibilit\u00e4tstests durchgef\u00fchrten H\u00e4molyse-Untersuchungen werden von uns gem\u00e4\u00df der Norm <a href=\"https:\/\/www.iso.org\/standard\/63448.html\"><b>EN ISO 10993-4<\/b><\/a> und den <a href=\"https:\/\/nano-test.de\/es\/service\/gute-laborpraxis-glp\/\"><b>GLP-Standards (Gute Laborpraxis)<\/b><\/a> international g\u00fcltig dokumentiert.<\/span><\/p><h3><span style=\"color: #000000;\">\u00bfQu\u00e9 es la hem\u00f3lisis?<\/span><\/h3><p><span style=\"color: #000000;\">El efecto hemol\u00edtico se defini\u00f3 anteriormente como una medida del efecto destructivo de un dispositivo m\u00e9dico sobre las c\u00e9lulas sangu\u00edneas (eritrocitos). Se espera que todos los dispositivos m\u00e9dicos o materiales que entren en contacto con la sangre no destruyan o da\u00f1en los gl\u00f3bulos rojos. Desde esta perspectiva, se requiere la prueba de hem\u00f3lisis para los siguientes grupos de productos:<\/span><\/p><ul><li><span style=\"color: #000000;\">Cat\u00e9teres intravasculares<\/span><\/li><li><span style=\"color: #000000;\">Sistemas de filtro de sangre<\/span><\/li><li><span style=\"color: #000000;\">Estilos<\/span><\/li><li><span style=\"color: #000000;\">Dispositivos de di\u00e1lisis<\/span><\/li><li><span style=\"color: #000000;\">Todos los dispositivos m\u00e9dicos que entran en contacto directo con la sangre<\/span><\/li><\/ul><h3><span style=\"color: #000000;\">Breve informaci\u00f3n sobre la norma EN ISO 10993-4<\/span><\/h3><p><span style=\"color: #000000;\">EN ISO 10993-4 es una norma internacional para la evaluaci\u00f3n biol\u00f3gica de las superficies de productos m\u00e9dicos que entran en contacto con la sangre. Tambi\u00e9n incluye pruebas de hem\u00f3lisis como parte de las pruebas de impacto en la sangre. Para presentar claramente el perfil de seguridad de un producto y determinar cient\u00edficamente si los productos pueden da\u00f1ar las c\u00e9lulas sangu\u00edneas, las pruebas de acuerdo con esta norma son de gran valor.<\/span><\/p><h3><span style=\"color: #000000;\">An\u00e1lisis fiables de acuerdo con los est\u00e1ndares GLP<\/span><\/h3><p><span style=\"color: #000000;\">Como laboratorio con la Declaraci\u00f3n de Conformidad de la OCDE \u201cBuenas Pr\u00e1cticas de Laboratorio\u201d, llevamos a cabo procesos de dispositivos m\u00e9dicos de acuerdo con los est\u00e1ndares GLP.<\/span><\/p><p><span style=\"color: #000000;\"><b>Nuestro alcance de servicios:<\/b><\/span><\/p><ul><li><span style=\"color: #000000;\">Pruebas de eficacia hemol\u00edtica de acuerdo con la norma EN ISO 10993-4<\/span><\/li><li><span style=\"color: #000000;\">Informes de an\u00e1lisis certificados por GLP<\/span><\/li><li><span style=\"color: #000000;\">Evaluaci\u00f3n de la seguridad biol\u00f3gica de los dispositivos m\u00e9dicos<\/span><\/li><\/ul><h3><span style=\"color: #000000;\">\u00bfPor qu\u00e9 nosotros<\/span><\/h3><p><span style=\"color: #000000;\">Descubra nuestros servicios para que pueda demostrar la seguridad biol\u00f3gica de sus dispositivos m\u00e9dicos y completar la entrada al mercado internacional sin problemas. Realizamos pruebas de acuerdo con EN ISO 10993-4 y cumplimos con los requisitos legales informando que sus productos son inofensivos para la salud humana.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>H\u00e4molytische Wirkungstests f\u00fcr medizinische Ger\u00e4te | EN ISO 10993-4 Die Nanolab Laboratorien Gruppe ist ein akkreditiertes Labor, das die Forschung, Entwicklung, Herstellung und Zulassung von medizinischen Ger\u00e4ten unterst\u00fctzt und zahlreiche nationale und internationale Normen und Vorschriften einh\u00e4lt. Aufgrund ihres direkten oder indirekten Kontakts mit Menschen ist einer der Tests, die an medizinischen Ger\u00e4ten durchgef\u00fchrt werden, \u2026 <a href=\"https:\/\/nano-test.de\/es\/2025\/07\/02\/test-auf-hamolytische-wirkung-en-iso-10993-4\/\" class=\"more-link\" title=\"Continue reading &lt;span class=\" screen-reader-text>Test auf h\u00e4molytische Wirkung | EN ISO 10993-4\u00ab&gt;Continue reading <span class=\"screen-reader-text\">Prueba de efecto hemol\u00edtico | EN ISO 10993-4<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":3174,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3173","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medizinprodukt-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Test 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