{"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\/fr\/2025\/07\/02\/test-auf-hamolytische-wirkung-en-iso-10993-4\/","title":{"rendered":"Test de l'effet h\u00e9molytique | 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;\">Tests d'impact h\u00e9molytiques pour dispositifs m\u00e9dicaux | EN ISO 10993-4<\/span><\/h2><p><span style=\"color: #000000;\">Le groupe Nanolab Laboratories est un laboratoire accr\u00e9dit\u00e9 qui soutient la recherche, le d\u00e9veloppement, la fabrication et l'approbation de dispositifs m\u00e9dicaux et est conforme \u00e0 de nombreuses normes et r\u00e9glementations nationales et internationales. En raison de leur contact direct ou indirect avec des personnes, l'un des tests effectu\u00e9s sur des dispositifs m\u00e9dicaux est le test d'effet h\u00e9molytique, dans lequel l'effet destructeur du dispositif m\u00e9dical sur les cellules sanguines (\u00e9rythrocytes) est mesur\u00e9.<\/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\/fr\/service\/gute-laborpraxis-glp\/\"><b>GLP-Standards (Gute Laborpraxis)<\/b><\/a> international g\u00fcltig dokumentiert.<\/span><\/p><h3><span style=\"color: #000000;\">What is hemolysis?<\/span><\/h3><p><span style=\"color: #000000;\">L'effet h\u00e9molytique a \u00e9t\u00e9 d\u00e9fini ci-dessus comme une mesure de l'effet destructeur d'un dispositif m\u00e9dical sur les cellules sanguines (\u00e9rythrocytes). Tous les dispositifs m\u00e9dicaux ou mat\u00e9riels qui entrent en contact avec le sang ne doivent pas d\u00e9truire ou endommager les globules rouges. De ce point de vue, le test d'h\u00e9molyse est requis pour les groupes de produits suivants :<\/span><\/p><ul><li><span style=\"color: #000000;\">Cath\u00e9ters intravasculaires<\/span><\/li><li><span style=\"color: #000000;\">Syst\u00e8mes de filtres sanguins<\/span><\/li><li><span style=\"color: #000000;\">Stents<\/span><\/li><li><span style=\"color: #000000;\">Dialysis devices<\/span><\/li><li><span style=\"color: #000000;\">Tous les dispositifs m\u00e9dicaux qui entrent directement en contact avec le sang<\/span><\/li><\/ul><h3><span style=\"color: #000000;\">Br\u00e8ves informations sur la norme EN ISO 10993-4<\/span><\/h3><p><span style=\"color: #000000;\">La norme EN ISO 10993-4 est une norme internationale pour l'\u00e9valuation biologique des surfaces des produits m\u00e9dicaux qui entrent en contact avec le sang. Il comprend \u00e9galement des tests d'h\u00e9molyse dans le cadre des tests d'impact sanguin. Afin de pr\u00e9senter clairement le profil de s\u00e9curit\u00e9 d'un produit et de d\u00e9terminer scientifiquement si les produits peuvent potentiellement endommager les cellules sanguines, les tests selon cette norme sont d'une grande valeur.<\/span><\/p><h3><span style=\"color: #000000;\">Des analyses fiables selon les normes GLP<\/span><\/h3><p><span style=\"color: #000000;\">En tant que laboratoire avec la d\u00e9claration de conformit\u00e9 de l'OCDE \u00ab Bonne pratique de laboratoire \u00bb, nous r\u00e9alisons des processus de dispositifs m\u00e9dicaux conform\u00e9ment aux normes GLP.<\/span><\/p><p><span style=\"color: #000000;\"><b>Notre gamme de services :<\/b><\/span><\/p><ul><li><span style=\"color: #000000;\">Essais d'efficacit\u00e9 h\u00e9molytique selon la norme EN ISO 10993-4<\/span><\/li><li><span style=\"color: #000000;\">Rapports d'analyses certifi\u00e9s par le GLP et valides au niveau international<\/span><\/li><li><span style=\"color: #000000;\">\u00c9valuation de la s\u00e9curit\u00e9 biologique des dispositifs m\u00e9dicaux<\/span><\/li><\/ul><h3><span style=\"color: #000000;\">Pourquoi nous<\/span><\/h3><p><span style=\"color: #000000;\">D\u00e9couvrez nos services afin que vous puissiez d\u00e9montrer la s\u00e9curit\u00e9 biologique de vos dispositifs m\u00e9dicaux et compl\u00e9ter l'entr\u00e9e sur le march\u00e9 international en douceur. Nous effectuons des tests conform\u00e9ment \u00e0 la norme EN ISO 10993-4 et r\u00e9pondons aux exigences l\u00e9gales en signalant que vos produits sont inoffensifs pour la sant\u00e9 humaine.<\/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\/fr\/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\u00a0&gt;Continue reading <span class=\"screen-reader-text\">Test de l'effet h\u00e9molytique | 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\/ 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