{"id":4487,"date":"2026-11-01T08:13:56","date_gmt":"2026-11-01T08:13:56","guid":{"rendered":"https:\/\/nano-test.de\/?p=4487"},"modified":"2026-11-06T06:10:08","modified_gmt":"2026-11-06T06:10:08","slug":"sensibilisierungstest-en-iso-10993-10","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/11\/01\/sensibilisierungstest-en-iso-10993-10\/","title":{"rendered":"Awareness test \u2013 EN ISO 10993-10"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4487\" class=\"elementor elementor-4487\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7eb58c88 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7eb58c88\" 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-66590bc ts-bg-color-over-image\" data-id=\"66590bc\" 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-601436ea elementor-widget elementor-widget-text-editor\" data-id=\"601436ea\" 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;\">Sensitization test \u2013 biocompatibility assessment according to EN ISO 10993-10<\/span><\/h1>\n<p><span style=\"color: #000000;\">Medical devices can trigger not only a physical but also an immunological reaction when they come into contact with the human body.<\/span><br><span style=\"color: #000000;\">Eine dieser Reaktionen ist die <strong>Sensibilisierung<\/strong>, bei der der K\u00f6rper eine allergische Reaktion auf die im Produkt enthaltenen chemischen Stoffe oder Materialbestandteile entwickelt. Der <strong>Awareness test \u2013 EN ISO 10993-10<\/strong> ist eine international anerkannte Norm zur Bewertung, ob Medizinprodukte solche allergischen Reaktionen ausl\u00f6sen k\u00f6nnen.<\/span><\/p>\n<p><span style=\"color: #000000;\">EN ISO 10993-10 is entitled \"Biological evaluation of medical devices \u2013 Part 10: Tests for skin sensitization\". This standard defines the methods used to determine whether delayed hypersensitivity reactions (type IV hypersensitivity) occur in contact with the skin or when it is applied to the body. For MDR (2017\/745) and FDA 510(k) applications, this test is required to be performed in accordance with Good Laboratory Practice (GLP) principles.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">What is sensitization and why is it tested?<\/span><\/h2>\n<p><span style=\"color: #000000;\">Sensitization is the process by which the immune system develops a \"memory\" for that substance after the body's first contact with it, and triggers a severe allergic reaction on the second contact. This reaction usually manifests itself in the form of skin redness, swelling, itching and eczema. Substances in medical devices that can trigger such reactions include:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Weichmacher und Stabilisatoren:<\/strong> Phthalate, Epoxidharze<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Metalllegierungen:<\/strong> Nickel, Kobalt, Chrom<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Latex- und Kautschukkomponenten:<\/strong> Nat\u00fcrliche Latexproteine, Vulkanisationsbeschleuniger<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Klebstoffe und Beschichtungen:<\/strong> Acrylate, Formaldehydharze<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Sterilisationsr\u00fcckst\u00e4nde:<\/strong> Ethylenoxidr\u00fcckst\u00e4nde<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">The sensitization test scientifically proves whether the product releases these substances through the skin or systemically to the body and whether it triggers an allergic reaction. Before the test is performed, a chemical characterization of the product (ISO 10993-18) is carried out to determine which substances can be released.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Sensitization test procedure<\/span><\/h2>\n<p><span style=\"color: #000000;\">EN ISO 10993-10 recommends three main methods for assessing awareness. The choice of method depends on the intended use of the product, the duration of contact and the properties of the extract to be tested.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<p><span style=\"color: #000000;\"><b>1. GPMT (Guinea Pig Maximization Test)<\/b><\/span><\/p>\n<p><span style=\"color: #000000;\">This is the most commonly used method, which is considered the gold standard. The test is performed on guinea pigs (guinea pigs) by a combination of intradermal injection and topical application. The test substance is mixed with the complete friend adjuvant (FCA) to enhance the immune system's response. After the induction phase, the test substance is administered to the animals again (challenge phase) and the skin reactions are evaluated.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<p><span style=\"color: #000000;\"><b>2. Buehler test (closed patch test)<\/b><\/span><\/p>\n<p><span style=\"color: #000000;\">It was developed as an alternative to GPMT. In this method, the test substance is applied to the skin of the guinea pigs in the form of a closed patch. No injection is used. It is particularly suitable for topical products and highly concentrated extracts.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<p><span style=\"color: #000000;\"><b>3. LLNA (Local Lymph Node Assay)<\/b><\/span><\/p>\n<p><span style=\"color: #000000;\">This method, performed on mice, measures cell proliferation (proliferation) in the ear lymph nodes using radioactive markers or bioluminescence techniques to determine sensitization potential. As it is more in line with the 3R principles (Replacement, Reduction, Refinement), it is increasingly preferred today. However, it may not be suitable for some device extracts.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- Tabellenanfang --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Comparison of sensitization test procedures<\/span><\/h2>\n<p><span style=\"color: #000000;\">The following table summarizes the sensitization test methods used under EN ISO 10993-10:<\/span><\/p>\n<table>\n<thead>\n<tr>\n<th><span style=\"color: #000000;\">Method<\/span><\/th>\n<th><span style=\"color: #000000;\">Animal model<\/span><\/th>\n<th><span style=\"color: #000000;\">Form of application<\/span><\/th>\n<th><span style=\"color: #000000;\">Advantages<\/span><\/th>\n<th><span style=\"color: #000000;\">Cons<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><span style=\"color: #000000;\"><strong>GPMT<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Guinea pig (Guinea Pig)<\/span><\/td>\n<td><span style=\"color: #000000;\">Intradermal injection + topical patch<\/span><\/td>\n<td><span style=\"color: #000000;\">High sensitivity, gold standard, widely recognized<\/span><\/td>\n<td><span style=\"color: #000000;\">Requires more animals, takes a long time (~30 days)<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Buehler test<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Guinea pig (Guinea Pig)<\/span><\/td>\n<td><span style=\"color: #000000;\">Closed patch (topical)<\/span><\/td>\n<td><span style=\"color: #000000;\">No injection, suitable for topical applications<\/span><\/td>\n<td><span style=\"color: #000000;\">The sensitivity can be lower than with the GPMT<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>LLNA<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">Mouse<\/span><\/td>\n<td><span style=\"color: #000000;\">Topical (Ear Skin)<\/span><\/td>\n<td><span style=\"color: #000000;\">Fewer animals, 3R compliant, quantitative results<\/span><\/td>\n<td><span style=\"color: #000000;\">Use of radioactive substances (for some variants), not suitable for certain substances<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"color: #000000;\"><!-- Ende der Tabelle --><\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Testverfahren --><\/span><\/p>\n<h2><span style=\"color: #000000;\">How does the sensitization test procedure work?<\/span><\/h2>\n<p><span style=\"color: #000000;\">Conducting a sensitization test for a medical device requires a careful procedure. This process is designed to reflect the clinical conditions of use of the product:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>1. Probenvorbereitung und Extraktion:<\/strong> Das Produkt wird gem\u00e4\u00df ISO 10993-12 mit polaren und unpolaren L\u00f6sungsmitteln extrahiert. Dadurch werden Chemikalien, die aus dem Medizinprodukt freigesetzt werden k\u00f6nnten, in die L\u00f6sung \u00fcberf\u00fchrt.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>2. Dosisfestlegung:<\/strong> Die Konzentration des Extrakts wird anhand der klinischen Anwendungsdosis und der Oberfl\u00e4che des Medizinprodukts berechnet.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>3. Induktionsphase:<\/strong> Die Testsubstanz wird den Tieren entsprechend der gew\u00e4hlten Methode verabreicht. Diese Phase sorgt daf\u00fcr, dass das Immunsystem gegen\u00fcber der Substanz sensibilisiert wird.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>4. Challenge-Phase:<\/strong> Nach einer bestimmten Zeit wird die Testsubstanz erneut in geringer Konzentration verabreicht.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>5. Beobachtung und Bewertung:<\/strong> Hautreaktionen (Erythem und \u00d6dem) werden nach 24, 48 und 72 Stunden beurteilt. Die Bewertung erfolgt anhand der Magnusson- und Kligman-Skala.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>6. Berichterstattung:<\/strong> Die Ergebnisse werden gem\u00e4\u00df den GLP-Standards dokumentiert. Es wird angegeben, ob das Produkt ein Sensibilisierungspotenzial aufweist.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Nano-Test --><\/span><\/p>\n<h3><span style=\"color: #000000;\">GLP Compliant Awareness Testing Services with Nano Test<\/span><\/h3>\n<p><span style=\"color: #000000;\">Die Biokompatibilit\u00e4tsbewertung Ihres Medizinprodukts erfordert nicht nur ein Testergebnis, sondern auch eine Dokumentation in einer Qualit\u00e4t, die den Anforderungen der Aufsichtsbeh\u00f6rden gerecht wird. <a href=\"https:\/\/nano-test.de\/en\/services\/\"><strong>Nano-Test<\/strong><\/a> ist mit seinen GLP-konformen Sensibilisierungstests gem\u00e4\u00df EN ISO 10993-10 Ihr zuverl\u00e4ssiger Partner in diesem Prozess.<\/span><\/p>\n<div class=\"highlight\">\n<h3><span style=\"color: #000000;\">Nano-Test \u2013 Performance Description<\/span><\/h3>\n<p><span style=\"color: #000000;\">Nano-Test bietet f\u00fcr Medizinprodukte <strong>Sensibilisierungstests<\/strong> gem\u00e4\u00df EN ISO 10993-10 an. In unseren pr\u00e4klinischen Laboren, die nach GLP (Gute Laborpraxis) und ISO\/IEC 17025 akkreditiert sind, werden die Methoden <strong>GPMT (Test zur Maximierung der Versuchstierzahl), Buehler-Test und LLNA (Lokaler Lymphknotentest)<\/strong> angewendet.<\/span><\/p>\n<p><span style=\"color: #000000;\">Unser Dienstleistungsprozess umfasst die ISO 10993-12-konforme Extraktion Ihres Produkts, die Dosisoptimierung, die In-vivo-Testphasen sowie histopathologische Auswertungen. Alle Arbeiten werden unter Einhaltung der Genehmigungen der Ethikkommissionen f\u00fcr Versuchstiere und unter tier\u00e4rztlicher Aufsicht durchgef\u00fchrt. Die Ergebnisse werden als <strong>GLP-Konformit\u00e4tsberichte<\/strong> mit vollst\u00e4ndiger R\u00fcckverfolgbarkeit bereitgestellt, die Sie f\u00fcr Ihre MDR- und FDA-510(k)-Antr\u00e4ge verwenden k\u00f6nnen.<\/span><\/p>\n<p><span style=\"color: #000000;\">At Nano-Test, we not only carry out tests, but also support you in the creation of your biocompatibility strategy (Biological Evaluation Plan \u2013 BEP) and provide you with valid data for communication with the regulatory authorities.<\/span><\/p>\n<\/div>\n<h3><span style=\"color: #000000;\">Advantages of Nano-Test's Sensitization Test:<\/span><\/h3>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Umfassende Auswahl an Methoden:<\/strong> Alle Methoden \u2013 GPMT, Buehler und LLNA \u2013 stehen zur Verf\u00fcgung.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>GLP-zertifizierte Infrastruktur:<\/strong> Alle Studien werden gem\u00e4\u00df den GLP-Grunds\u00e4tzen und den ALCOA+-Anforderungen durchgef\u00fchrt.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Schnelle Planung:<\/strong> Je nach Ger\u00e4tekategorie und Kontaktzeit wird die am besten geeignete Teststrategie festgelegt.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Fachkundiges Tier\u00e4rzteteam:<\/strong> Das Wohlergehen der Versuchstiere und ethische Standards werden auf h\u00f6chstem Niveau gewahrt.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Einhaltung der 3R-Prinzipien:<\/strong> Wo immer m\u00f6glich, werden Methoden wie LLNA empfohlen, die weniger Tiere erfordern.<\/span><\/li>\n<\/ul>\n<div class=\"note\"><span style=\"color: #000000;\"><strong>Note:<\/strong> Der Sensibilisierungstest ist nur ein Teil der Biokompatibilit\u00e4tsbewertung eines Medizinprodukts. Er sollte im Rahmen der ISO 10993-1 zusammen mit anderen Tests wie Irritation, Zytotoxizit\u00e4t und systemischer Toxizit\u00e4t ausgewertet werden. Nano-Test beschleunigt Ihren Prozess, indem es all diese Tests aus einer Hand anbietet.<\/span><\/div>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Ergebnis --><\/span><\/p>\n<p><span style=\"color: #000000;\">Sensitization is one of the most common and annoying adverse reactions that can be caused by medical devices.<\/span><br><span style=\"color: #000000;\"><strong>Sensitization test \u2013 <a href=\"https:\/\/www.iso.org\/standard\/40884.html\">EN ISO 10993-10<\/a><\/strong> ist ein entscheidender Schritt, um wissenschaftlich nachzuweisen, ob Ihr Produkt dieses Risiko birgt. Die Auswahl der richtigen Testmethode, die ordnungsgem\u00e4\u00dfe Durchf\u00fchrung der Extraktion und die Berichterstattung der Ergebnisse gem\u00e4\u00df den GLP-Standards sind Voraussetzung f\u00fcr einen reibungslosen Ablauf des beh\u00f6rdlichen Zulassungsverfahrens.<\/span><\/p>\n<p><span style=\"color: #000000;\">Nano-Test comprehensively meets the sensitization testing needs of medical device manufacturers with its preclinical infrastructure, expert staff, and GLP-compliant processes. Partner with Nano-Test to increase the safety of your product and accelerate market access.<\/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>Sensibilisierungstest \u2013 Bewertung der Biokompatibilit\u00e4t gem\u00e4\u00df EN ISO 10993-10 Medizinprodukte k\u00f6nnen bei Kontakt mit dem menschlichen K\u00f6rper nicht nur eine physikalische, sondern auch eine immunologische Reaktion ausl\u00f6sen. Eine dieser Reaktionen ist die Sensibilisierung, bei der der K\u00f6rper eine allergische Reaktion auf die im Produkt enthaltenen chemischen Stoffe oder Materialbestandteile entwickelt. Der Sensibilisierungstest \u2013 EN ISO \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/11\/01\/sensibilisierungstest-en-iso-10993-10\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Sensibilisierungstest \u2013 EN ISO 10993-10\u201c&gt;Continue reading <span class=\"screen-reader-text\">Awareness test \u2013 EN ISO 10993-10<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4489,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4487","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>Sensibilisierungstest \u2013 EN ISO 10993-10 | Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Sensibilisierungstest nach ISO 10993-10: Allergisches Potenzial von Medizinprodukten und Materialien bewerten. 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