{"id":701,"date":"2026-02-11T18:14:44","date_gmt":"2026-02-11T17:14:44","guid":{"rendered":"https:\/\/relaunch.k-labor.wp4.visual4.com\/?page_id=701"},"modified":"2026-05-07T10:50:05","modified_gmt":"2026-05-07T08:50:05","slug":"medical-technology","status":"publish","type":"page","link":"https:\/\/dekra.k-labor.de\/en\/medical-technology\/","title":{"rendered":"Medical technology. Testing of medical devices."},"content":{"rendered":"\n<p>Innovative medical devices include many diverse components and parts made from a wide variety of polymers, metal alloys and additional composite materials. These materials offer countless significant advantages, such as smaller component sizes and longer durability. But each material also has very specific chemical and physical characteristics that can affect the health and protection of patients and users alike.<\/p>\n\n\n\n<p>As part of our testing of medical devices, we examine these materials through comprehensive material testing, in which chemical and physical properties are evaluated either directly on the components or using extracted samples. Testing is carried out using state-of-the-art techniques such as microscopy, spectrometry and numerous mechanical methods. We also use environmental simulations to test the service life and functionality of a medical device under extreme conditions.<\/p>\n\n\n\n<p>As part of comprehensive medical device testing, these and additional methods enable our medical device testing laboratory to provide precise information on the chemical composition and usability of medical materials.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. Media resistance testing of medical devices<\/h2>\n\n\n\n<p>Regular cleaning and disinfection of medical devices is essential to ensure the highest standards of hygiene. The materials used must be able to withstand repeated contact with cleaning agents and disinfectants without losing their functionality or safety. In our test laboratory for medical devices, we offer specialized procedures to evaluate chemical resistance in accordance with relevant DIN EN ISO standards.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Our testing services at a glance:<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Media resistance of plastics:<\/strong> We test the resistance of plastic components to various disinfectants and cleaners to ensure that no material degradation or discoloration occurs \u2013 an essential part of any sound medical device testing.<\/li>\n\n\n\n<li><strong>Media resistance of surfaces:<\/strong> Surfaces of medical devices, especially those with coatings or special finishes, are tested for their resistance to chemical influences.<\/li>\n\n\n\n<li><strong>Corrosion testing of metal components:<\/strong> Metallic parts of medical devices, such as surgical instruments, are tested for susceptibility to corrosion to ensure their longevity and safety.<\/li>\n\n\n\n<li><strong>Failure analysis of medical devices:<\/strong> In the event of material failure or damage, we carry out detailed analyses to identify the causes and make recommendations for material improvements or alternative cleaning procedures.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Relevant standards:<\/h2>\n\n\n\n<p>Our test methods are based on recognized DIN EN ISO standards that define specific requirements and test methods for the resistance of medical devices. For example, DIN EN ISO 21530 describes test methods for determining the resistance of materials to chemical disinfectants used for external surfaces of dental equipment.<\/p>\n\n\n\n<p>By complying with these standards, we ensure that your medical devices meet the highest quality and safety standards and withstand the challenges of everyday clinical practice.<\/p>\n\n\n\n<p>Rely on our expertise in medical device testing \u2013 for maximum safety, reliability and longevity of your products.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. Failure analysis of medical devices<\/h2>\n\n\n\n<p>Medical devices are subject to high mechanical, thermal and chemical stresses in daily use. Damage to these products can have serious consequences for patient safety and functionality. In our specialized testing laboratory for medical devices, we carry out detailed damage analyses to systematically identify the causes of material failure and uncover potential for improvement.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Our services in the failure analysis of medical devices:<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Microscopic examinations:<\/li>\n<\/ul>\n\n\n\n<p>Using high-resolution light and scanning electron microscopy, we analyze cracks, material fatigue or surface degradation.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Chemical analyses:<\/li>\n<\/ul>\n\n\n\n<p>We investigate material changes, residues or interactions with disinfectants and cleaners using spectroscopic and chromatographic methods.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mechanical tests:<\/li>\n<\/ul>\n\n\n\n<p>Load tests and hardness measurements provide information about changes in the mechanical properties of materials.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Corrosion tests:<\/li>\n<\/ul>\n\n\n\n<p>Metallic components such as surgical instruments or implants are tested for corrosion damage caused by environmental influences and cleaning processes.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Fracture and crack analyses:<\/li>\n<\/ul>\n\n\n\n<p>Using fractography and stress analyses, we identify causes of fracture and evaluate possible design or material defects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Relevant norms and test standards:<\/h2>\n\n\n\n<p>Our tests are based on recognized standards such as<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>DIN EN ISO 13485:<\/strong> Requirements for quality management systems for medical devices<\/li>\n\n\n\n<li><strong>DIN EN ISO 10993-9:<\/strong> Evaluation of material degradation of medical devices<\/li>\n\n\n\n<li><strong>ASTM G65:<\/strong> Wear resistance of metallic surfaces<\/li>\n<\/ul>\n\n\n\n<p>With our expertise in materials testing and failure analysis, we support manufacturers, operators and users of medical devices in minimizing safety risks and optimizing product quality.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">FAQ<\/h2>\n\n\n\n<div data-wp-context=\"{ &quot;autoclose&quot;: false, &quot;accordionItems&quot;: [] }\" data-wp-interactive=\"core\/accordion\" role=\"group\" class=\"wp-block-accordion is-layout-flow wp-block-accordion-is-layout-flow\">\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-1&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-1-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-1\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\"><strong>What preparation do my medical device test specimens need?<\/strong><\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-1\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-1-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p>Specimens should be sent in in the delivery condition, if applicable sterilised or preconditioned. Please state whether the test is to be performed in the new condition, after sterilisation cycles (EtO, gamma, steam) or after simulated reprocessing.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div data-wp-context=\"{ &quot;autoclose&quot;: false, &quot;accordionItems&quot;: [] }\" data-wp-interactive=\"core\/accordion\" role=\"group\" class=\"wp-block-accordion is-layout-flow wp-block-accordion-is-layout-flow\">\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-2&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-2-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-2\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\"><strong>What turnaround time should I expect?<\/strong><\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-2\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-2-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p>Individual tests 2\u20133 weeks, complete MDR test packages including biocompatibility pre-stages and ageing 6\u201310 weeks.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div data-wp-context=\"{ &quot;autoclose&quot;: false, &quot;accordionItems&quot;: [] }\" data-wp-interactive=\"core\/accordion\" role=\"group\" class=\"wp-block-accordion is-layout-flow wp-block-accordion-is-layout-flow\">\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-3&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-3-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-3\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\"><strong>Where do I send the test specimens?<\/strong><\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-3\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-3-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p>Dekra Automobil GmbH, Unidekstra\u00dfe 5, 75015 Bretten, together with the sample accompanying form (download area). Please state the lot number and production date, as this is essential for MDR documentation.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div data-wp-context=\"{ &quot;autoclose&quot;: false, &quot;accordionItems&quot;: [] }\" data-wp-interactive=\"core\/accordion\" role=\"group\" class=\"wp-block-accordion is-layout-flow wp-block-accordion-is-layout-flow\">\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-4&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-4-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-4\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\"><strong>Are your tests accredited and MDR-suitable?<\/strong><\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-4\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-4-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p>The relevant physical, chemical and ageing-related tests are accredited in accordance with DIN EN ISO\/IEC 17025. For biocompatibility in accordance with ISO 10993, we work in an accredited partnership with specialised laboratories.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div data-wp-context=\"{ &quot;autoclose&quot;: false, &quot;accordionItems&quot;: [] }\" data-wp-interactive=\"core\/accordion\" role=\"group\" class=\"wp-block-accordion is-layout-flow wp-block-accordion-is-layout-flow\">\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-5&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-5-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-5\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\"><strong>May we submit the test report in the approval procedure with notified bodies?<\/strong><\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-5\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-5-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p>Yes, that is the typical intended use. Our test reports meet the requirements of MDR Annex II\/III.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div data-wp-context=\"{ &quot;autoclose&quot;: false, &quot;accordionItems&quot;: [] }\" data-wp-interactive=\"core\/accordion\" role=\"group\" class=\"wp-block-accordion is-layout-flow wp-block-accordion-is-layout-flow\">\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-6&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-6-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-6\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\"><strong>Do you also support cleaning and sterilisation validations?<\/strong><\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-6\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-6-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p>Yes \u2013 from material compatibility with cleaning and disinfection agents, through sterilisation design, to ageing simulations for determining product service life.<\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Innovative medical devices include many diverse components and parts made from a wide variety of polymers, metal alloys and additional composite materials. These materials offer countless significant advantages, such as smaller component sizes and longer durability. But each material also has very specific chemical and physical characteristics that can affect the health and protection of [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-701","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical technology. Testing of medical devices. - k-labor<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/dekra.k-labor.de\/medizintechnik\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical technology. Testing of medical devices. - k-labor\" \/>\n<meta property=\"og:description\" content=\"Innovative medical devices include many diverse components and parts made from a wide variety of polymers, metal alloys and additional composite materials. These materials offer countless significant advantages, such as smaller component sizes and longer durability. 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