{"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\/en\/2025\/07\/02\/test-auf-hamolytische-wirkung-en-iso-10993-4\/","title":{"rendered":"Test for hemolytic effect | 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;\">Hemolytic Impact Tests for Medical Devices | EN ISO 10993-4<\/span><\/h2><p><span style=\"color: #000000;\">The NanoLab Laboratories Group is an accredited laboratory that supports the research, development, manufacture and approval of medical devices and complies with numerous national and international standards and regulations. Due to their direct or indirect contact with people, one of the tests performed on medical devices is the hemolytic effect test, in which the destructive effect of the medical device on blood cells (erythrocytes) is measured.<\/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\/en\/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;\">The hemolytic effect was defined above as a measurement of the destructive effect of a medical device on blood cells (erythrocytes). All medical devices or materials that come into contact with blood are expected not to destroy or damage red blood cells. From this perspective, the hemolysis test is required for the following product groups:<\/span><\/p><ul><li><span style=\"color: #000000;\">Intravascular Catheters<\/span><\/li><li><span style=\"color: #000000;\">Blood filter systems<\/span><\/li><li><span style=\"color: #000000;\">Stents<\/span><\/li><li><span style=\"color: #000000;\">Dialysis devices<\/span><\/li><li><span style=\"color: #000000;\">All medical devices that come into direct contact with blood<\/span><\/li><\/ul><h3><span style=\"color: #000000;\">Brief information on the standard EN ISO 10993-4<\/span><\/h3><p><span style=\"color: #000000;\">EN ISO 10993-4 is an international standard for the biological evaluation of medical products surfaces that come into contact with blood. It also includes hemolysis tests as part of the blood impact tests. In order to clearly present the safety profile of a product and to scientifically determine whether products can potentially damage blood cells, tests according to this standard are of great value.<\/span><\/p><h3><span style=\"color: #000000;\">Reliable analyzes according to GLP standards<\/span><\/h3><p><span style=\"color: #000000;\">As a laboratory with the OECD declaration of conformity \u201cGood Laboratory Practice\u201d, we carry out medical device processes in accordance with the GLP standards.<\/span><\/p><p><span style=\"color: #000000;\"><b>Our scope of services:<\/b><\/span><\/p><ul><li><span style=\"color: #000000;\">Hemolytic Efficacy Tests in accordance with EN ISO 10993-4 standard<\/span><\/li><li><span style=\"color: #000000;\">GLP-certified, internationally valid analysis reports<\/span><\/li><li><span style=\"color: #000000;\">Biological safety assessment of medical devices<\/span><\/li><\/ul><h3><span style=\"color: #000000;\">Why we<\/span><\/h3><p><span style=\"color: #000000;\">Discover our services so that you can demonstrate the biological safety of your medical devices and complete the entry into the international market smoothly. We perform tests in accordance with EN ISO 10993-4 and meet the legal requirements by reporting that your products are harmless to human health.<\/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\/en\/2025\/07\/02\/test-auf-hamolytische-wirkung-en-iso-10993-4\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Test auf h\u00e4molytische Wirkung | EN ISO 10993-4\u201c&gt;Continue reading <span class=\"screen-reader-text\">Test for hemolytic effect | 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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