{"id":12019,"date":"2025-11-26T16:15:56","date_gmt":"2025-11-26T15:15:56","guid":{"rendered":"https:\/\/medtech-ingenieur.de\/?p=12019"},"modified":"2025-11-25T10:16:43","modified_gmt":"2025-11-25T09:16:43","slug":"emv-test-medizinische-geraete","status":"publish","type":"post","link":"https:\/\/medtech-ingenieur.de\/en\/emv-test-medizinische-geraete\/","title":{"rendered":"What does EMC mean for medical devices in practice?"},"content":{"rendered":"

Why EMC testing is vital in medical technology<\/h2>\n

Stellen Sie sich vor, ein Patient liegt w\u00e4hrend einer kritischen \u00dcberwachung im Krankenhaus. Pl\u00f6tzlich klingelt das Smartphone eines Besuchers \u2013 und das \u00dcberwachungsger\u00e4t zeigt pl\u00f6tzlich Fehler an oder liefert verf\u00e4lschte Daten. Eine be\u00e4ngstigende Vorstellung, nicht wahr? Genau solche Szenarien verhindert die EMV-Pr\u00fcfung w\u00e4hrend des Zulassungsprozesses.Doch welche Pr\u00fcfungen sind n\u00f6tig, um eine Zulassung f\u00fcr ein medizinisches elektrisches Ger\u00e4t zu erhalten? Warum sind Precompliance-Tests sinnvoll? Und wie k\u00f6nnen Sie Ihr Ger\u00e4t am einfachsten testen? Darum soll es heute in diesem Blogartikel gehen.<\/p>\n

Which EMC standards apply to medical devices?<\/h2>\n

Um ein Medizinprodukt in der EU auf den Markt zu bringen, muss die MDR (Medical Device Regulation) erf\u00fcllt werden. Diese legt die rechtlichen Anforderungen an den Hersteller fest. Mit dem CE-Kennzeichen erkl\u00e4rt der Hersteller, dass sein Produkt alle relevanten europ\u00e4ischen Rechtsvorschriften erf\u00fcllt. Ein Teil dieses umfangreichen Prozesses ist der EMV-Test.Die grundlegende Norm f\u00fcr den Test ist die IEC 60601-1-2. Diese Norm legt die Anforderungen an die St\u00f6rfestigkeit und die St\u00f6raussendung f\u00fcr alle Arten von Medizinprodukten fest. Sie definiert die Pr\u00fcfpegel und Pr\u00fcffrequenzen, denen ein Ger\u00e4t widerstehen muss, sowie welche Grenzwerte f\u00fcr die St\u00f6rabstrahlung einzuhalten sind.Die IEC 60601-1-2 kann durch besondere Festlegungen erg\u00e4nzt werden, abh\u00e4ngig davon, um was f\u00fcr ein Medizinprodukt es sich handelt, z.B. 60601-2-4 Kapitel 202 bei Defibrillatoren.<\/p>\n<\/p>\n

Which EMC tests must medical devices pass?<\/h2>\n

The standards require a variety of tests, which can be divided into two main categories: immunity tests and emission tests.<\/p>\n\n\n\n\n\n\n\n\n\n\n
\n

category<\/strong><\/p>\n<\/th>\n

\n

standard<\/strong><\/p>\n<\/th>\n

\n

test<\/strong><\/p>\n<\/th>\n

\n

Description<\/strong><\/p>\n<\/th>\n<\/tr>\n<\/thead>\n

\n

immunity<\/p>\n<\/td>\n

\n

IEC 61000-4-2<\/p>\n<\/td>\n

\n

ESD<\/p>\n<\/td>\n

\n

Electrostatic discharge<\/p>\n<\/td>\n<\/tr>\n

\n

IEC 61000-4-3<\/p>\n<\/td>\n

\n

(One) irradiated fields<\/p>\n<\/td>\n

\n

Influence of high-frequency electromagnetic fields<\/p>\n<\/td>\n<\/tr>\n

\n

IEC 61000-4-4<\/p>\n<\/td>\n

\n

Fast transients and bursts<\/p>\n<\/td>\n

\n

Interference pulses are coupled onto network and data lines.<\/p>\n<\/td>\n<\/tr>\n

\n

IEC 61000-4-5<\/p>\n<\/td>\n

\n

Impulse voltages<\/p>\n<\/td>\n

\n

High-energy overvoltage impulses on supply lines<\/p>\n<\/td>\n<\/tr>\n

\n

IEC 61000-4-6<\/p>\n<\/td>\n

\n

Conducted disturbances<\/p>\n<\/td>\n

\n

High-frequency interference signals are coupled onto all cables.<\/p>\n<\/td>\n<\/tr>\n

\n

IEC 61000-4-8<\/p>\n<\/td>\n

\n

Magnetic field<\/p>\n<\/td>\n

\n

The device is exposed to a strong magnetic field at the mains frequency.<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Why are pre-compliance tests so important in EMC development?<\/h2>\n

Often, a product is initially developed without a comprehensive EMC analysis and then subjected to certification testing at the end. This frequently results in costly rework with makeshift solutions such as additional shielding, ferrites, and cable shields, or repeated, time-consuming test loops. This reactive approach is not only frustrating but also wastes valuable time and money.<\/p>\n

Consideration of EMC requirements must begin as early as the initial system development phase. The major advantage: The costs for EMC measures are minimal in the design phase.<\/strong> (often only a few euros for additional components on the circuit board), but increase exponentially the later they need to be implemented in the development process.<\/p>\n

The graphic by Henry W. Ott (1988) perfectly illustrates the core principle: <\/strong><\/p>\n

The later in the development process an EMC measure is implemented, the higher the associated costs.<\/strong> At the same time, the number of available solution options decreases drastically. Pre-compliance testing is key to identifying problems early, when solutions are still simple and inexpensive.<\/p>\n

Our goal is to avoid this expensive and inefficient trial-and-error process. Instead, we are building on a systematic EMC development work<\/strong>.<\/p>\n

\"\"<\/span><\/p>\n

Figure 1: Figure 1-1 from Electromagnetic compatibility Engineering by Henry W. Ott<\/p>\n

<\/strong>How we conduct EMC tests for medical devices<\/h2>\n

Laboratory measurements \u2013 pre-compliance tests<\/span><\/h3>\n

Before a device undergoes the expensive, accredited certification measurement, we carry out extensive testing. EMC testing during development<\/strong> through. This allows us to identify and resolve problems early, saving time and money. Our most important tools are with us.<\/p>\n

Use of oscilloscope, spectrum analyzer and ESD simulator<\/h3>\n

The oscilloscope<\/strong> is our universal diagnostic tool. We use it not only for pure signal analysis, but above all to... The effects of disturbances and their countermeasures become visible<\/strong> to do this, for example, switching spikes from power supplies or the effectiveness of an RC snubber, as in this blog article: https:\/\/medtech-ingenieur.de\/stoeraussendung-eines-batterie-ladereglers\/<\/a>.<\/p>\n

With the Spectrum analyzer <\/strong>We measure the frequency ranges in which a device emits radiation. This helps us develop targeted filtering measures, locate sources of interference, and make layout changes. You can find more information, for example, in this blog article: https:\/\/medtech-ingenieur.de\/wie-behebt-man-emv-probleme\/<\/a><\/p>\n

\"\"<\/span>\"\"<\/span><\/p>\n

Michael Wichert <\/p>\n

Hardware developer at MEDtech Engineer<\/p>\n

My practical tip: Measuring common-mode currents<\/strong><\/p>\n

Hier noch ein Beispiel f\u00fcr eine Messung, die Sie auch selbst durchf\u00fchren sollten:Mit einer Stromzange k\u00f6nnen Sie die Gleichtaktstr\u00f6me auf den Kabeln Ihres Ger\u00e4ts schnell und unkompliziert messen. Diese Str\u00f6me sind h\u00e4ufig die Ursache daf\u00fcr, dass Grenzwerte f\u00fcr abgestrahlte oder leitungsgef\u00fchrte St\u00f6raussendungen \u00fcberschritten werden.Durch die Kontrolle der Gleichtaktstr\u00f6me \u2013 idealerweise bereits w\u00e4hrend der Entwicklung und bei jeder Layout-\u00c4nderung \u2013 lassen sich viele EMV-Probleme fr\u00fchzeitig erkennen und gezielt beheben.<\/p>\n

 <\/p>\n

ESD exposure can be critical for medical devices. With our ESD simulator<\/strong> We will check reproducible and controlled<\/strong>, how robust the circuit is against such discharges, where protective measures are needed, and verify their effectiveness.<\/p>\n

\"\"<\/span><\/p>\n

EMC test chamber for realistic test conditions<\/h3>\n

The measurements with oscilloscope and spectrum analyzer take place in our laboratory (so-called). Pre-compliance tests<\/strong>For more meaningful measurements of the radiated disturbances and immunity to interference radiation<\/strong> do we use a EMC test chamber<\/strong>. The measurement chamber for pre-compliance measurements is electromagnetically shielded and therefore virtually free from external interference. The measurement setup largely corresponds to that of a certification measurement and thus enables a meaningful and practical evaluation.<\/p>\n

Early and development-accompanying measurements and our experience from numerous development projects and approval tests allow us to develop new circuits quickly and reliably.<\/p>\n

Conclusion: EMC pre-compliance tests lead to faster, safe approval<\/h2>\n

For us as a development service provider, EMC is a consistent process. Quality and safety considerations<\/strong>, which is considered from the first circuit sketch to the final printed circuit board version.<\/p>\n

Through EMC pre-compliance testing during the development of medical devices, we identify and resolve problems early on. This allows us to enter the final, accredited measurement with a device that is already optimized and pre-validated. saves costs,<\/strong> by implementing cost-effective solutions and reducing the number of test loops. This in turn significantly reduces the time-to-market<\/strong>.<\/p>\n

Do you have a project where you need support or our EMC expertise? <\/strong>Contact us!<\/strong><\/p>","protected":false},"excerpt":{"rendered":"

Warum EMV-Tests in der Medizintechnik lebenswichtig sind Stellen Sie sich vor, ein Patient liegt w\u00e4hrend einer kritischen \u00dcberwachung im Krankenhaus. Pl\u00f6tzlich klingelt das Smartphone eines Besuchers \u2013 und das \u00dcberwachungsger\u00e4t zeigt pl\u00f6tzlich Fehler an oder liefert verf\u00e4lschte Daten. Eine be\u00e4ngstigende Vorstellung, nicht wahr? Genau solche Szenarien verhindert die EMV-Pr\u00fcfung w\u00e4hrend des Zulassungsprozesses.Doch welche Pr\u00fcfungen sind […]<\/p>\n","protected":false},"author":36,"featured_media":12182,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2,4,14,604,468],"tags":[188,187,673,796],"class_list":["post-12019","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-allgemein","category-hardware-entwicklung","category-normen","category-qualitaet","category-testen","tag-elektromagnetische-vertraeglichkeit","tag-emv","tag-emv-test","tag-precompliance","post-wrapper","thrv_wrapper"],"yoast_head":"\nWas bedeutet EMV f\u00fcr medizinische Ger\u00e4te in der Praxis? - MEDtech Ingenieur GmbH<\/title>\n<meta name=\"description\" content=\"Erfahren Sie, wie EMV-Tests die Sicherheit medizinischer Ger\u00e4te gew\u00e4hrleisten und wie Precompliance-Tests Zeit und Kosten sparen.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/medtech-ingenieur.de\/en\/emv-test-medizinische-geraete\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Was bedeutet EMV f\u00fcr medizinische Ger\u00e4te in der Praxis? - MEDtech Ingenieur GmbH\" \/>\n<meta property=\"og:description\" content=\"Erfahren Sie, wie EMV-Tests die Sicherheit medizinischer Ger\u00e4te gew\u00e4hrleisten und wie Precompliance-Tests Zeit und Kosten sparen.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/medtech-ingenieur.de\/en\/emv-test-medizinische-geraete\/\" \/>\n<meta property=\"og:site_name\" content=\"MEDtech Ingenieur GmbH\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/medtechIngenieur\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-26T15:15:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2025\/10\/Hardwareentwickler-beim-herstellen-von-Platinen-819x1024.png\" \/>\n\t<meta property=\"og:image:width\" content=\"819\" \/>\n\t<meta property=\"og:image:height\" content=\"1024\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Michael Wichert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@MedtechIng\" \/>\n<meta name=\"twitter:site\" content=\"@MedtechIng\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Michael Wichert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/emv-test-medizinische-geraete\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/emv-test-medizinische-geraete\\\/\"},\"author\":{\"name\":\"Michael Wichert\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/#\\\/schema\\\/person\\\/48282da48d1ac1eeb0186bcf718a63c4\"},\"headline\":\"Was bedeutet EMV f\u00fcr medizinische Ger\u00e4te in der Praxis?\",\"datePublished\":\"2025-11-26T15:15:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/emv-test-medizinische-geraete\\\/\"},\"wordCount\":1051,\"publisher\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/emv-test-medizinische-geraete\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/medtech-ingenieur.de\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/Hardwareentwickler-beim-herstellen-von-Platinen.png\",\"keywords\":[\"elektromagnetische Vertr\u00e4glichkeit\",\"EMV\",\"emv test\",\"precompliance\"],\"articleSection\":[\"Allgemein\",\"Hardware\",\"Normen\",\"Qualit\u00e4t\",\"Testen\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/emv-test-medizinische-geraete\\\/\",\"url\":\"https:\\\/\\\/medtech-ingenieur.de\\\/emv-test-medizinische-geraete\\\/\",\"name\":\"Was bedeutet EMV f\u00fcr medizinische Ger\u00e4te in der Praxis? 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