{"id":3204,"date":"2025-07-10T18:26:41","date_gmt":"2025-07-10T18:26:41","guid":{"rendered":"https:\/\/nano-test.de\/?p=3204"},"modified":"2025-07-10T18:33:29","modified_gmt":"2025-07-10T18:33:29","slug":"genotoxizitat-karzinogenitat-und-reproduktionstoxizitat-nach-der-norm-iso-10993-nano-test-de","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2025\/07\/10\/genotoxizitat-karzinogenitat-und-reproduktionstoxizitat-nach-der-norm-iso-10993-nano-test-de\/","title":{"rendered":"Genotoxicity, carcinogenicity and reproductive toxicity according to the ISO 10993 standard | nano-test.de"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3204\" class=\"elementor elementor-3204\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-34cd3f42 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"34cd3f42\" 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-ae66a01 ts-bg-color-over-image\" data-id=\"ae66a01\" 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-385f7fd4 elementor-widget elementor-widget-text-editor\" data-id=\"385f7fd4\" 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<h1><span style=\"color: #000000;\">Genotoxicity, carcinogenicity and reproductive toxicity according to the ISO 10993 standard<\/span><\/h1><p><span style=\"color: #000000;\">Die Herstellung medizinischer Ger\u00e4te unterliegt weltweit zahlreichen Normen und gesetzlichen Vorschriften. Als Branche, die mit der menschlichen Gesundheit zu tun hat und keine Nachl\u00e4ssigkeiten zul\u00e4sst, sind in allen Phasen, angefangen bei der Forschung und Entwicklung, Erfahrung, Professionalit\u00e4t und fachliche Unterst\u00fctzung gefragt. Bevor ein Medizinprodukt auf den Markt gebracht werden kann, muss es einen gesetzlichen Prozess durchlaufen. In diesem Zusammenhang stehen verschiedene Kontrollen und Laboranalysen im Vordergrund. Auf der Grundlage der Norm ISO 10993 muss ein Verfahren durchgef\u00fchrt werden, das den Anforderungen der <a href=\"https:\/\/www.fda.gov\/\">FDA<\/a> entspricht.<\/span><\/p><p><span style=\"color: #000000;\">Before we go into the studies on \u201cgenotoxicity, carcinogenicity and reproductive toxicity\u201d in our article, we first want to clarify how many classes are medical devices and which class is relevant for the tests mentioned.<\/span><\/p><h2 style=\"text-align: left;\"><span style=\"color: #000000;\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-medium wp-image-3207 alignright\" src=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/07\/In-wie-viele-Klassen-werden-Medizinprodukte-eingeteilt-300x180.png\" alt=\"\" width=\"300\" height=\"180\" srcset=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/07\/In-wie-viele-Klassen-werden-Medizinprodukte-eingeteilt-300x180.png 300w, https:\/\/nano-test.de\/wp-content\/uploads\/2025\/07\/In-wie-viele-Klassen-werden-Medizinprodukte-eingeteilt.png 750w\" sizes=\"(max-width: 300px) 100vw, 300px\">How many classes are medical devices classified?<\/span><\/h2><p style=\"text-align: left;\"><span style=\"color: #000000;\">According to the classification system specified by the FDA, 1700 types of medical devices are divided into 16 medical specialties. Each of these products is divided into one of three classes, depending on the potential risk to patients, type of product, scope and duration of use.<\/span><\/p><p><span style=\"color: #000000;\">\u2013 <strong><u>Class 1 - Medical equipment: stethoscopes, bandages, bed accessories, latex gloves, surgical masks<\/u><\/strong><\/span><\/p><p><span style=\"color: #000000;\">Medical devices of this class are considered devices with the lowest risk. Therefore, they are subject to less strict control procedures compared to the general procedure.<\/span><\/p><p><span style=\"color: #000000;\">\u2013 <strong><u>Class 2 - Medical Devices: Blood Pressure Cuffs, Pregnancy Tests, Syringes, Blood Transfusion Devices, Motorized Wheelchairs, Contact Lenses, Specific Diagnostic Software<\/u><\/strong><\/span><\/p><p><span style=\"color: #000000;\">Diese Klasse umfasst 43 % der <a href=\"https:\/\/nano-test.de\/en\/service\/medizinprodukt\/\">Medical devices<\/a> und umfasst Produkte mit mittlerem Risiko. Zus\u00e4tzlich zu den allgemeinen Kontrollen m\u00fcssen sie spezielle Kontrollen hinsichtlich ihrer Leistung, Kennzeichnung, klinischen Testdaten und Konformit\u00e4tsanforderungen durchlaufen.<\/span><\/p><p><span style=\"color: #000000;\">\u2013 <strong><u>Class 3 - Pacemakers, Defibrillators, Implant Prostheses, Cochlear Implants, Breast Implants, Intraocular Lenses, Kidney Stents<\/u><\/strong><\/span><\/p><p><span style=\"color: #000000;\">These products of the highest risk group are subjected to stricter testing and analysis procedures and must go through all certification levels in full. They are subject to general controls and approval prior to placing on the market.<\/span><\/p><p><span style=\"color: #000000;\"><img decoding=\"async\" class=\"size-medium wp-image-3206 alignleft\" src=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/07\/Wissenswertes-uber-Genotoxizitatsstudien-300x180.png\" alt=\"\" width=\"300\" height=\"180\" srcset=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/07\/Wissenswertes-uber-Genotoxizitatsstudien-300x180.png 300w, https:\/\/nano-test.de\/wp-content\/uploads\/2025\/07\/Wissenswertes-uber-Genotoxizitatsstudien.png 750w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/span><span style=\"color: #000000; font-family: 'Roboto Condensed', Arial, Helvetica, sans-serif; font-size: 36px; font-weight: bold;\">Things to know about genotoxicity studies<\/span><\/p><p><span style=\"color: #000000;\">Das <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/center-devices-and-radiological-health\">CDRH (Center for Devices and Radiological Health)<\/a> und das <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/center-biologics-evaluation-and-research-cber\">CBER (Center for Biologics Evaluation and Research)<\/a> verlangen Genotoxizit\u00e4tstests f\u00fcr Medizinprodukte, die l\u00e4nger als 24 Stunden bis 30 Tage oder l\u00e4nger mit Knochen, Schleimh\u00e4uten oder anderen Geweben in Kontakt kommen. Dar\u00fcber hinaus kann dies auch f\u00fcr bereits legal vermarktete Medizinprodukte unabh\u00e4ngig von ihrer Verwendungsdauer verlangt werden. Bei Produkten mit gro\u00dfer Oberfl\u00e4che und damit erh\u00f6htem Potenzial f\u00fcr das Austreten von Chemikalien sowie bei Produkten, die mit Blut au\u00dferhalb des K\u00f6rpers in Kontakt kommen, kann eine Genotoxizit\u00e4tspr\u00fcfung erforderlich sein, wenn die M\u00f6glichkeit besteht, dass Stoffe in den systemischen Kreislauf gelangen.<\/span><\/p><p><span style=\"color: #000000;\">If an in vitro genotoxicity test on mammalian cells is required:<\/span><\/p><table><tbody><tr><td width=\"102\"><span style=\"color: #000000;\">OECD 490<\/span><\/td><td width=\"663\"><span style=\"color: #000000;\">In vitro cell mutation tests on mammalian cells using thymidine kinase gene<\/span><\/td><\/tr><tr><td width=\"102\"><span style=\"color: #000000;\">OECD 473<\/span><\/td><td width=\"663\"><span style=\"color: #000000;\">In vitro chromosome aberration test on mammalian cells<\/span><\/td><\/tr><tr><td width=\"102\"><span style=\"color: #000000;\">OECD 487<\/span><\/td><td width=\"663\"><span style=\"color: #000000;\">In vitro micronucleus test on mammalian cells<\/span><\/td><\/tr><\/tbody><\/table><p><span style=\"color: #000000;\">If an in vitro genotoxicity test is required:<\/span><\/p><table><tbody><tr><td width=\"102\"><span style=\"color: #000000;\">OECD 474<\/span><\/td><td width=\"663\"><span style=\"color: #000000;\">Mammalian Erythrocyte Micronucleus Test<\/span><\/td><\/tr><tr><td width=\"102\"><span style=\"color: #000000;\">OECD 475<\/span><\/td><td width=\"663\"><span style=\"color: #000000;\">Mammalian Bone Marrow Chromosomal Aberration Test<\/span><\/td><\/tr><\/tbody><\/table><p><span style=\"color: #000000;\">These tests must be performed with the support of authorized and accredited laboratories.<\/span><\/p><h2><span style=\"color: #000000;\">Carcinogenicity Testing of Medical Devices and Details<\/span><\/h2><p><span style=\"color: #000000;\">In addition to products that are used for wound healing (which come into contact with damaged or injured surfaces), products that come into contact with the outdoor environment and are implanted must also be tested for carcinogenicity. The FDA recommends checking your carcinogenicity potential for medical devices that come into contact with the body for more than 30 days. Even if a product passes the genotoxicity test, it should be tested for carcinogenicity. In this case, it should be considered that no genotoxic carcinogens can be present and that the carcinogenic effect depends on various factors.<\/span><\/p><h2><span style=\"color: #000000;\">Why is the reproductive toxicity of medical devices assessed?<\/span><\/h2><p><span style=\"color: #000000;\">The potential impact on reproductive function, embryonic development (teratogenicity) and prenatal and early postnatal development must be examined in medical devices and materials. This includes the following medical devices:<\/span><\/p><p><span style=\"color: #000000;\">\u2013 Implant materials in which chemical leaks may come into contact with the reproductive organs. In this case, the nature or duration of the contact does not matter.<\/span><\/p><p><span style=\"color: #000000;\">\u2013 Materials or components of products that come into contact with the reproductive organs<\/span><\/p><p><span style=\"color: #000000;\">For further information on the ISO 10993 standard and the work carried out under this standard, as well as for support in the certification, testing and analysis of your products, please feel free to contact us. Our team of experts will be happy to answer any questions you may have on this topic.<\/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>Genotoxizit\u00e4t, Karzinogenit\u00e4t und Reproduktionstoxizit\u00e4t nach der Norm ISO 10993 Die Herstellung medizinischer Ger\u00e4te unterliegt weltweit zahlreichen Normen und gesetzlichen Vorschriften. Als Branche, die mit der menschlichen Gesundheit zu tun hat und keine Nachl\u00e4ssigkeiten zul\u00e4sst, sind in allen Phasen, angefangen bei der Forschung und Entwicklung, Erfahrung, Professionalit\u00e4t und fachliche Unterst\u00fctzung gefragt. Bevor ein Medizinprodukt auf den \u2026 <a href=\"https:\/\/nano-test.de\/en\/2025\/07\/10\/genotoxizitat-karzinogenitat-und-reproduktionstoxizitat-nach-der-norm-iso-10993-nano-test-de\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Genotoxizit\u00e4t, Karzinogenit\u00e4t und Reproduktionstoxizit\u00e4t nach der Norm ISO 10993 | nano-test.de\u201c&gt;Continue reading <span class=\"screen-reader-text\">Genotoxicity, carcinogenicity and reproductive toxicity according to the ISO 10993 standard | nano-test.de<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":3205,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3204","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 - 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