{"id":1827,"date":"2018-05-08T14:38:17","date_gmt":"2018-05-08T12:38:17","guid":{"rendered":"http:\/\/medtech-ingenieur.de\/?p=1827"},"modified":"2021-08-06T14:43:11","modified_gmt":"2021-08-06T13:43:11","slug":"isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination","status":"publish","type":"post","link":"https:\/\/medtech-ingenieur.de\/en\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\/","title":{"rendered":"Creating insulation diagrams according to 60601-1 \u2013 Part 1: Basic concepts of insulation coordination"},"content":{"rendered":"<p>The electrical safety of medical devices has been the subject of several articles:<\/p>\n<ul>\n<li>In the article <a href=\"https:\/\/medtech-ingenieur.de\/en\/isolationsdiagramme-in-der-medizintechnik\/\">Insulation diagrams in medical technology\u00a0<\/a>Isolation diagrams are discussed in general.<\/li>\n<li>In the article <a href=\"https:\/\/medtech-ingenieur.de\/en\/elektrische-sicherheit-in-der-medizintechnik-nach-60601-1\/\">Electrical safety in medical technology<\/a> describes how electrical medical devices are classified and which principles ensure the safety of electrical devices.<\/li>\n<\/ul>\n<p>This article will once again explain the basic concepts of insulation coordination in connection with 60601-1. The next article will then show how we proceed when creating insulation diagrams.<!--more--><\/p>\n<p>Electrical safety is documented by a safety concept and insulation diagram. Although the term &quot;insulation diagram&quot; does not appear in 60601-1, the appendices contain some examples of insulation distances (Annex J) and simplified patient leakage current diagrams (Annex K). The insulation diagram is nevertheless required for approval, as it is part of the IEC Test Report Form (IEC TRF). For battery-operated devices, the insulation diagram can be so simple that it is sometimes omitted, or the approval body creates it itself. For more complex devices, such as those with a mains connection and multiple applied parts, it is absolutely necessary.<\/p>\n<div class=\"table-scrollable\">\r\n<table style=\"min-width: 300px;\">\r\n<tbody>\r\n<tr>\r\n<td colspan=\"2\" bgcolor=\"#FFFFFF\"><center><strong>Your contact person:<\/strong><\/center><\/td>\r\n<\/tr>\r\n<tr>\r\n<td style=\"text-align: center;\" bgcolor=\"#f9f9f9\"><strong><span style=\"color: #2c2ccc;\">Dipl.-Ing. Martin Bosch<\/span><\/strong><span style=\"color: #2c2ccc;\">, shareholder, hardware developer<\/span> <br \/>E-mail: <a href=\"mailto:bosch@medtech-ingenieur.de\">bosch@medtech-ingenieur.de<\/a> <br \/>Phone:\u00a0\u00a0<a href=\"tel:+499131691241\">+49 9131 691 241<\/a><\/td>\r\n<td style=\"background-image: url('https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2017\/11\/MARTIN_250px-1-150x150.jpg'); background-repeat: no-repeat; background-position: top; background-size: cover;\" bgcolor=\"#f9f9f9\" width=\"70px\">\u00a0<\/td>\r\n<\/tr>\r\n<tr>\r\n<td colspan=\"2\" bgcolor=\"#FFFFFF\"><center><p>Do you need support with the development of your medical device? We&#039;re happy to help! MEDtech Ingenieur GmbH offers hardware development, software development, systems engineering, mechanical development, and consulting services from a single source. Contact us.<\/p>\r\n<center><a class=\"large blue button\" href=\"https:\/\/medtech-ingenieur.de\/en\/kontakt\/\">make contact<\/a><\/center><br\/><\/center><\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<\/div>\n<p>An insulation diagram offers many advantages:<\/p>\n<ul>\n<li>It represents the safety-relevant parts of the device in the form of a block diagram.<\/li>\n<li>It serves as a basis for improvements, ideas, alternatives within the project<\/li>\n<li>It serves as a basis for discussions with the admissions office.<\/li>\n<li>It shows possibilities of how separation lines can be laid in a more technically or financially advantageous manner.<\/li>\n<li>It serves as the basis for the dielectric strength tests.<\/li>\n<li>It can show at a glance potential hazards that can arise when connecting external devices. For example, if a PC is connected via USB and suddenly the patient is no longer disconnected from the power supply by two protective measures.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2>Basic concepts of isolation coordination<\/h2>\n<p>Before describing our approach to creating isolation diagrams in the next article, some terms need to be clarified:<\/p>\n<p><strong>MOOP<\/strong> \u2013 English: Means of Operator Protection, protective measure to protect all persons except the patient from electric shock<\/p>\n<p><strong>MOP<\/strong> \u2013 English: Means of Patient Protection, protective measure to protect the patient from electric shock<\/p>\n<p><strong>MOP<\/strong> \u2013 English: Means of Protection, protective measure within the scope of 60601-1 for protection against electric shock, each protective measure must be classified as either MOPP or MOOP.<\/p>\n<p><strong>Degree of contamination \u2013<\/strong>\u00a0Contamination is defined as any contamination with gases, liquids, or solids that reduces the electrical resistance or insulation capacity of an isolating gap. Four levels of contamination are distinguished, with contamination level 4 no longer being acceptable for insulation that represents a protective measure.<\/p>\n<p><strong>Air distance<\/strong> \u2013 The shortest distance between two conductive parts through air<\/p>\n<p><strong>Creepage distance<\/strong> \u2013 The shortest distance between two conductive parts along a solid material (IC package, circuit board).<\/p>\n<figure id=\"attachment_1832\" aria-describedby=\"caption-attachment-1832\" style=\"width: 906px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-1832 size-full\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke.png\" alt=\"Luft- und Kriechstrecke\" width=\"906\" height=\"423\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke.png 906w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke-300x140.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke-768x359.png 768w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke-100x47.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke-150x70.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke-200x93.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke-450x210.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke-600x280.png 600w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke-900x420.png 900w\" sizes=\"auto, (max-width: 906px) 100vw, 906px\" \/><figcaption id=\"caption-attachment-1832\" class=\"wp-caption-text\">Clearance and creepage distance<\/figcaption><\/figure>\n<p><strong>Basic insulation<\/strong> \u2013 Insulation to protect against electric shock<\/p>\n<p><strong>Double insulation<\/strong> \u2013 Insulation consisting of basic insulation and additional insulation<\/p>\n<p><strong>Additional insulation<\/strong> \u2013 Insulation in addition to and independent of the basic insulation as a further protective measure against electric shock<\/p>\n<p><strong>Reinforced insulation<\/strong> \u2013 A single insulation measure, but equivalent to the protection of double insulation.<\/p>\n<p><strong>Secondary circuit \u2013<\/strong>\u00a0A circuit without direct connection to the mains, supplied by an isolated power supply<\/p>\n<p><strong>primary circuit<\/strong> (Primary) \u2013 Circuit part that is directly connected to the mains connection or another external power supply.<\/p>\n<p><strong>Comparative tracking index CTI<\/strong> Comparative tracking index (CTI) \u2013 The comparative tracking index is a measure of contamination sensitivity and is highly dependent on the material and surface finish. If the CTI of the material used is unknown, IIIb is used; otherwise, you can inquire with the circuit board manufacturer, for example.<\/p>\n<p><strong>Installation or overvoltage category \u2013<\/strong>\u00a0This provides information about the quality of the power supply, especially which overvoltage peaks must be tolerated.<\/p>\n<p>&nbsp;<\/p>\n<p>Those are the basic concepts. The next section will cover the creation of the isolation diagram using an example.<\/p>\n<p>If you are interested in this topic, please contact us in our <a href=\"https:\/\/medtech-ingenieur.de\/en\/newsletter\/\">Newsletter<\/a> We will soon be publishing a small brochure on insulation diagrams, which covers this topic in detail and is ideal for both initial training and as a reference.<\/p>","protected":false},"excerpt":{"rendered":"<p>Die elektrische Sicherheit von medizinischen Ger\u00e4ten war schon das Thema von mehreren Artikeln: Im Artikel Isolationsdiagramme in der Medizintechnik\u00a0werden Isolationsdiagramme allgemein behandelt. Im Artikel Elektrische Sicherheit in der Medizintechnik wird beschrieben, wie elektrische medizinische Ger\u00e4te klassifiziert sind und durch welche Prinzipien die Sicherheit von elektrischen Ger\u00e4ten gew\u00e4hrleistet wird. In diesem Artikel sollen noch einmal die [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1832,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,14],"tags":[223,222,23],"class_list":["post-1827","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-hardware-entwicklung","category-normen","tag-60601-1","tag-isolationsdiagramm","tag-medizintechnik","post-wrapper","thrv_wrapper"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Isolationsdiagramme erstellen nach 60601-1 - Teil 1: Grundbegriffe der Isolationskoordination - MEDtech Ingenieur GmbH<\/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:\/\/medtech-ingenieur.de\/en\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Isolationsdiagramme erstellen nach 60601-1 - Teil 1: Grundbegriffe der Isolationskoordination - MEDtech Ingenieur GmbH\" \/>\n<meta property=\"og:description\" content=\"Die elektrische Sicherheit von medizinischen Ger\u00e4ten war schon das Thema von mehreren Artikeln: Im Artikel Isolationsdiagramme in der Medizintechnik\u00a0werden Isolationsdiagramme allgemein behandelt. Im Artikel Elektrische Sicherheit in der Medizintechnik wird beschrieben, wie elektrische medizinische Ger\u00e4te klassifiziert sind und durch welche Prinzipien die Sicherheit von elektrischen Ger\u00e4ten gew\u00e4hrleistet wird. In diesem Artikel sollen noch einmal die [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/medtech-ingenieur.de\/en\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\/\" \/>\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:author\" content=\"https:\/\/www.facebook.com\/medtechIngenieur\/\" \/>\n<meta property=\"article:published_time\" content=\"2018-05-08T12:38:17+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-08-06T13:43:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke.png\" \/>\n\t<meta property=\"og:image:width\" content=\"906\" \/>\n\t<meta property=\"og:image:height\" content=\"423\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Martin Bosch\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@https:\/\/twitter.com\/MedtechIng\" \/>\n<meta name=\"twitter:site\" content=\"@MedtechIng\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Martin Bosch\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\\\/\"},\"author\":{\"name\":\"Martin Bosch\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/#\\\/schema\\\/person\\\/4a6ce76ff044f5fc88a30484c695fd84\"},\"headline\":\"Isolationsdiagramme erstellen nach 60601-1 &#8211; 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Sein Fachgebiet umfasst die Entwicklung von Embedded Elektronik, speziell f\u00fcr medizinische Anwendungen. Dabei liegt sein Fokus auf dem Design von Leiterplatten und Schaltungen, die sowohl Mikrocontroller als auch analoge Schaltungstechnik integrieren. Diese kommen in einer Vielzahl von Ger\u00e4ten zur Anwendung, von Blutanalyseger\u00e4ten bis hin zu Defibrillatoren.\",\"sameAs\":[\"https:\\\/\\\/www.medtech-ingenieur.de\",\"https:\\\/\\\/www.facebook.com\\\/medtechIngenieur\\\/\",\"https:\\\/\\\/x.com\\\/https:\\\/\\\/twitter.com\\\/MedtechIng\"],\"url\":\"https:\\\/\\\/medtech-ingenieur.de\\\/en\\\/author\\\/martin\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Isolationsdiagramme erstellen nach 60601-1 - Teil 1: Grundbegriffe der Isolationskoordination - MEDtech Ingenieur GmbH","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/medtech-ingenieur.de\/en\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\/","og_locale":"en_US","og_type":"article","og_title":"Isolationsdiagramme erstellen nach 60601-1 - Teil 1: Grundbegriffe der Isolationskoordination - MEDtech Ingenieur GmbH","og_description":"Die elektrische Sicherheit von medizinischen Ger\u00e4ten war schon das Thema von mehreren Artikeln: Im Artikel Isolationsdiagramme in der Medizintechnik\u00a0werden Isolationsdiagramme allgemein behandelt. Im Artikel Elektrische Sicherheit in der Medizintechnik wird beschrieben, wie elektrische medizinische Ger\u00e4te klassifiziert sind und durch welche Prinzipien die Sicherheit von elektrischen Ger\u00e4ten gew\u00e4hrleistet wird. In diesem Artikel sollen noch einmal die [&hellip;]","og_url":"https:\/\/medtech-ingenieur.de\/en\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\/","og_site_name":"MEDtech Ingenieur GmbH","article_publisher":"https:\/\/www.facebook.com\/medtechIngenieur","article_author":"https:\/\/www.facebook.com\/medtechIngenieur\/","article_published_time":"2018-05-08T12:38:17+00:00","article_modified_time":"2021-08-06T13:43:11+00:00","og_image":[{"width":906,"height":423,"url":"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2018\/05\/Luft-und-Kriechstrecke.png","type":"image\/png"}],"author":"Martin Bosch","twitter_card":"summary_large_image","twitter_creator":"@https:\/\/twitter.com\/MedtechIng","twitter_site":"@MedtechIng","twitter_misc":{"Written by":"Martin Bosch","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/medtech-ingenieur.de\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\/#article","isPartOf":{"@id":"https:\/\/medtech-ingenieur.de\/isolationsdiagramme-erstellen-nach-60601-1-teil-1-grundbegriffe-der-isolationskoordination\/"},"author":{"name":"Martin Bosch","@id":"https:\/\/medtech-ingenieur.de\/#\/schema\/person\/4a6ce76ff044f5fc88a30484c695fd84"},"headline":"Isolationsdiagramme erstellen nach 60601-1 &#8211; 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