{"id":11751,"date":"2026-05-25T09:00:00","date_gmt":"2026-05-25T07:00:00","guid":{"rendered":"https:\/\/tps-elektronik.com\/?p=11751"},"modified":"2026-05-18T03:09:41","modified_gmt":"2026-05-18T01:09:41","slug":"medical-device-electromagnetic-compatibility-test-lab","status":"publish","type":"post","link":"https:\/\/tps-elektronik.com\/en\/medical-device-electromagnetic-compatibility-test-lab\/","title":{"rendered":"TPS Medical Device EMC Testing: IEC 60601-1-2 &amp; EN 60601 Accredited Electromagnetic Compatibility Test Lab for FDA &amp; CE"},"content":{"rendered":"<article class=\"blog-post\" lang=\"en\"><header>\n<p><strong>News Update:<\/strong> TPS Elektronik has officially expanded the capabilities of its accredited EMC laboratory to provide comprehensive compliance solutions for the most demanding sectors. For system integrators, panel builders, and procurement teams, navigating the regulatory landscape for medical, automotive, and industrial electronics is a high-stakes endeavor. A failed <strong>electromagnetic compatibility test<\/strong> during the final stages of product development can derail FDA or CE approvals, leading to catastrophic delays and budget overruns.<\/p>\n<p>To mitigate these risks, TPS Elektronik\u2019s upgraded facility now offers specialized <strong>medical device EMC testing<\/strong> to IEC 60601-1-2 standards, alongside advanced automotive and industrial screening. By integrating these testing capabilities directly into the R&amp;D and manufacturing lifecycle, we ensure your products achieve compliance on the first pass.<\/p>\n<p><a class=\"cta-primary\" href=\"https:\/\/tps-elektronik.com\/en\/services\/emv-laboratory\/\">Request a Quote for Your Electromagnetic Compatibility Test \u2192<\/a><\/p>\n<\/header><nav class=\"toc\" aria-label=\"Table of contents\">\n<h2 id=\"toc\">Table of contents<\/h2>\n<ol>\n<li><a href=\"#medical-emc-testing\">1. Medical Device EMC Testing: Navigating IEC 60601-1-2<\/a><\/li>\n<li><a href=\"#fda-ce-approval\">2. The Role of an Electromagnetic Compatibility Test in FDA &amp; CE Approval<\/a><\/li>\n<li><a href=\"#automotive-emc\">3. Automotive Electromagnetic Compatibility Testing &amp; EV Infrastructure<\/a><\/li>\n<li><a href=\"#industrial-screening\">4. Industrial EMC Testing Lab &amp; Product Development Screening<\/a><\/li>\n<li><a href=\"#faq\">5. FAQ<\/a><\/li>\n<\/ol>\n<\/nav>\n<section id=\"medical-emc-testing\">\n<h2>1. Medical Device EMC Testing: Navigating IEC 60601-1-2<\/h2>\n<p>The medical device industry operates under the strictest regulatory frameworks globally. The 4th Edition of the IEC 60601-1-2 standard significantly increased the immunity requirements for medical electrical equipment, reflecting the growing prevalence of wireless technologies (like smartphones and Wi-Fi routers) in clinical and home healthcare environments.<\/p>\n<p>As a dedicated <strong>IEC 60601-1-2 EMC lab<\/strong>, TPS Elektronik provides rigorous <strong>medical electromagnetic compatibility testing<\/strong>. We evaluate essential performance criteria under severe electromagnetic disturbances. Our testing protocols include elevated Electrostatic Discharge (ESD) levels (up to 15kV air discharge) and increased radiated RF immunity fields (up to 28 V\/m for specific communication bands).<\/p>\n<div id=\"attachment_11789\" style=\"width: 1418px\" class=\"wp-caption alignnone\"><img decoding=\"async\" aria-describedby=\"caption-attachment-11789\" class=\"size-full wp-image-11789\" src=\"https:\/\/tps-elektronik.com\/wp-content\/uploads\/2026\/04\/Industrial-Power-Supply-Thermal-Management-1.jpg\" alt=\"Industrial Power Supply Thermal Management Industrie Netzteil W\u00e4rmemanagement\" width=\"1408\" height=\"768\" \/><p id=\"caption-attachment-11789\" class=\"wp-caption-text\">Industrial Power Supply Thermal Management<br \/>Industrie Netzteil W\u00e4rmemanagement<\/p><\/div>\n<p>For procurement teams and electrical engineers, partnering with a lab that understands the nuances of medical collateral standards is critical. We don&#8217;t just run the tests; we help you define the &#8220;Essential Performance&#8221; of your device and tailor the test plan accordingly. Learn more about our approach in our guide on <a href=\"https:\/\/tps-elektronik.com\/en\/emc-lab-electrical-safety-testing-medical-devices-standards\/\">EMC lab and electrical safety testing for medical devices<\/a>.<\/p>\n<\/section>\n<section id=\"fda-ce-approval\">\n<h2>2. The Role of an Electromagnetic Compatibility Test in FDA &amp; CE Approval<\/h2>\n<p>Whether you are submitting a 510(k) to the <a href=\"https:\/\/www.fda.gov\/medical-devices\" target=\"_blank\" rel=\"nofollow noopener\">FDA<\/a> or compiling a Technical File for CE marking under the Medical Device Regulation (MDR), a formal <strong>electromagnetic compatibility test<\/strong> report from an accredited laboratory is mandatory. Regulatory bodies scrutinize these reports to ensure that your device will neither emit intolerable electromagnetic interference nor succumb to it.<\/p>\n<p>Our laboratory ensures that your documentation is flawless. We provide comprehensive test reports that align perfectly with the <a href=\"https:\/\/tps-elektronik.com\/en\/european-emc-directive-emc-product-certification-emissions-immunity-testing\/\">European EMC Directive<\/a> and FDA consensus standards. By combining EMC testing with our electrical safety evaluations, we offer a streamlined path to market. Discover how we integrate these disciplines in our article on <a href=\"https:\/\/tps-elektronik.com\/en\/electrical-safety-testing-medical-devices-emc-compliance\/\">electrical safety testing and EMC compliance<\/a>.<\/p>\n<p><a class=\"cta-primary\" href=\"https:\/\/tps-elektronik.com\/en\/services\/emv-laboratory\/\">Schedule Your Medical Device EMC Testing Today \u2192<\/a><\/p>\n<\/section>\n<section id=\"automotive-emc\">\n<h2>3. Automotive Electromagnetic Compatibility Testing &amp; EV Infrastructure<\/h2>\n<p>Beyond medical devices, the rapid electrification of the automotive sector has created a massive demand for specialized testing. Modern electric vehicles (EVs) and their charging infrastructures operate at high voltages and high switching frequencies, creating harsh electromagnetic environments.<\/p>\n<p>TPS Elektronik operates a state-of-the-art <strong>automotive EMC test facility<\/strong>. We serve as a premier <strong>CISPR 25 radiated emissions lab<\/strong>, evaluating electronic sub-assemblies (ESAs) for both OEMs and aftermarket suppliers. Our capabilities include rigorous <strong>automotive electromagnetic compatibility testing<\/strong> for transient emissions and immunity along supply lines (ISO 7637 and ISO 16750 series).<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-13477\" src=\"https:\/\/tps-elektronik.com\/wp-content\/uploads\/2026\/05\/Custom-Industrial-Power-Supply-PCB-Design-2.jpg\" alt=\"Custom-Industrial-Power-Supply-PCB-Design\" width=\"1408\" height=\"768\" \/><\/p>\n<p>Furthermore, as the infrastructure for e-mobility expands, <strong>EV charging EMC testing<\/strong> has become a critical service. We test onboard chargers (OBCs) and external charging stations to ensure they do not disrupt vehicle communications or the local power grid. Read about our success in this sector in our <a href=\"https:\/\/tps-elektronik.com\/en\/case-studies\/electromagnetic-compatibility-testing-customer-case\/\">electromagnetic compatibility testing customer case studies<\/a>.<\/p>\n<\/section>\n<section id=\"industrial-screening\">\n<h2>4. Industrial EMC Testing Lab &amp; Product Development Screening<\/h2>\n<p>For panel builders and system integrators developing heavy industrial machinery, waiting until the final prototype to perform an <strong>electromagnetic compatibility test<\/strong> is a costly gamble. Industrial environments are notoriously noisy, requiring robust immunity to electrical fast transients (EFT) and heavy surges.<\/p>\n<p>Our <strong>industrial EMC testing lab<\/strong> offers proactive <strong>product development EMC screening<\/strong>. Using near-field probes and spectrum analyzers, our engineers work alongside your R&amp;D team to identify emission hotspots on the PCB level before the enclosure is even finalized. This pre-compliance approach allows for inexpensive layout changes or the strategic placement of ferrites and shielding, rather than expensive post-production retrofits.<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-13482\" src=\"https:\/\/tps-elektronik.com\/wp-content\/uploads\/2026\/05\/High-Efficiency-Power-Supply-Load-Testing-3.jpg\" alt=\"High-Efficiency-Power-Supply-Load-Testing\" width=\"1408\" height=\"768\" \/><\/p>\n<p>We guide you through the entire process, from initial design reviews to final certification. For a deeper understanding of our methodology, explore our comprehensive <a href=\"https:\/\/tps-elektronik.com\/en\/how-to-test-electromagnetic-compatibility-emc-guide\/\">guide on how to test electromagnetic compatibility<\/a>.<\/p>\n<p><a class=\"cta-primary\" href=\"https:\/\/tps-elektronik.com\/en\/services\/emv-laboratory\/\">Book a Product Development EMC Screening Session \u2192<\/a><\/p>\n<\/section>\n<section id=\"faq\">\n<h2>5. FAQ<\/h2>\n<div class=\"faq-container\">\n<div class=\"faq-item\">\n<h3>Why is IEC 60601-1-2 testing mandatory for medical devices?<\/h3>\n<p>IEC 60601-1-2 is the internationally recognized collateral standard for medical electrical equipment. An accredited <strong>electromagnetic compatibility test<\/strong> to this standard is required by the FDA and European Notified Bodies to prove the device is safe and will not fail due to electromagnetic disturbances in healthcare environments.<\/p>\n<\/div>\n<div class=\"faq-item\">\n<h3>What is product development EMC screening?<\/h3>\n<p><strong>Product development EMC screening<\/strong> (or pre-compliance testing) involves evaluating a product&#8217;s electromagnetic behavior early in the design phase. It helps engineers identify and fix issues like radiated emissions at the PCB level, saving time and money compared to failing a formal certification test later.<\/p>\n<\/div>\n<div class=\"faq-item\">\n<h3>Does your automotive EMC test facility handle EV charging stations?<\/h3>\n<p>Yes. Our <strong>automotive EMC test facility<\/strong> is fully equipped for <strong>EV charging EMC testing<\/strong>. We evaluate both the vehicle-side components (like OBCs) and the infrastructure-side charging stations to ensure compliance with CISPR and ISO standards.<\/p>\n<\/div>\n<div class=\"faq-item\">\n<h3>How does EMC testing relate to electrical safety?<\/h3>\n<p>EMC and electrical safety are deeply intertwined. For example, adding a filter capacitor to solve an EMC emissions issue might increase leakage current, causing the device to fail electrical safety tests. TPS evaluates both simultaneously to ensure holistic compliance. See our <a href=\"https:\/\/tps-elektronik.com\/en\/case-studies\/customer-case-electrical-safety-testing-medical-devices\/\">customer case on electrical safety testing for medical devices<\/a> for more details.<\/p>\n<\/div>\n<\/div>\n<\/section>\n<footer style=\"background: #2d5797; padding: 30px; border-radius: 14px; margin-top: 40px;\">\n<p style=\"color: #ffffff; font-size: 16px; line-height: 1.6; margin: 0;\"><strong>Secure your market entry with confidence.<\/strong><br \/>Whether you are developing life-saving medical devices, next-generation EV chargers, or robust industrial control panels, TPS Elektronik provides the accredited testing and engineering support you need. 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For system integrators, panel builders, and procurement teams, navigating the regulatory landscape for medical, automotive, and industrial electronics is a high-stakes endeavor. A failed electromagnetic compatibility test during the final stages\u2026 <a href=\"https:\/\/tps-elektronik.com\/en\/medical-device-electromagnetic-compatibility-test-lab\/\">Read More &raquo;<\/a><\/p>\n","protected":false},"author":9,"featured_media":13482,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[58],"tags":[],"class_list":["post-11751","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>TPS Medical Device EMC Testing: IEC 60601-1-2 &amp; EN 60601 Accredited Electromagnetic Compatibility Test Lab for FDA &amp; CE - TPS<\/title>\n<meta name=\"description\" content=\"Accelerate FDA &amp; CE approvals with our accredited electromagnetic compatibility test for medical, automotive, and industrial devices.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/tps-elektronik.com\/en\/medical-device-electromagnetic-compatibility-test-lab\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TPS Medical Device EMC Testing: IEC 60601-1-2 &amp; 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