{"id":3005,"date":"2019-02-25T11:24:46","date_gmt":"2019-02-25T09:24:46","guid":{"rendered":"http:\/\/medtech-ingenieur.de\/?p=3005"},"modified":"2021-08-06T14:40:25","modified_gmt":"2021-08-06T13:40:25","slug":"wo-gilt-welche-norm","status":"publish","type":"post","link":"https:\/\/medtech-ingenieur.de\/en\/wo-gilt-welche-norm\/","title":{"rendered":"Which standard applies where?"},"content":{"rendered":"<p>Which standard must be observed for the approval of an electrical medical device? This article will explain how to determine this for the most important countries (i.e., the EU, the US, and China). The article refers to the 60601 family of standards. Additional legal requirements may apply to approval, such as environmental directives like RoHS (EU) and EMC requirements like FCC approval (US).<\/p>\n<p>The basis for electrical medical devices in these countries is the IEC 60601 family of standards. Using the EMC standard for medical electrical devices, IEC 60601-1-2, as an example, we will determine whether it is valid and which version it applies to.<\/p>\n<p>Interestingly, different versions of the EMC standard are currently valid in all three countries (as of February 2019). We&#039;ll see which ones they are in a moment.<\/p>\n<h3>EU<\/h3>\n<p>In the EU, harmonized standards are published in the Official Journal of the EU. This offers a search function:<\/p>\n<p><a href=\"https:\/\/eur-lex.europa.eu\/oj\/direct-access.html?locale=de\">https:\/\/eur-lex.europa.eu\/oj\/direct-access.html?locale=de<\/a><\/p>\n<p>You can search for the standard and find the currently valid version and also the statement whether this standard is sufficient for the presumption of conformity:<\/p>\n<figure id=\"attachment_3019\" aria-describedby=\"caption-attachment-3019\" style=\"width: 871px\" class=\"wp-caption alignnone\"><a href=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche.png\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3019 size-full\" style=\"font-family: Georgia, 'Times New Roman', 'Bitstream Charter', Times, serif; font-size: 16px;\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche.png\" alt=\"\" width=\"871\" height=\"207\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche.png 871w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche-300x71.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche-768x183.png 768w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche-100x24.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche-150x36.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche-200x48.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche-450x107.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CENELEC_Normsuche-600x143.png 600w\" sizes=\"auto, (max-width: 871px) 100vw, 871px\" \/><\/a><figcaption id=\"caption-attachment-3019\" class=\"wp-caption-text\">Valid version of 60601-1-2 at https:\/\/eur-lex.europa.eu\/oj\/direct-access.html<\/figcaption><\/figure>\n<h3>USA<\/h3>\n<p>In the US, the FDA (Food and Drug Administration) is the government agency responsible for medical devices. The FDA publishes its &quot;recognized consensus standards&quot; on the following website:<\/p>\n<p><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfstandards\/search.cfm\">https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfstandards\/search.cfm<\/a><\/p>\n<p>If you search for 60601-1-2, for example, you will get the following result:<\/p>\n<figure id=\"attachment_3024\" aria-describedby=\"caption-attachment-3024\" style=\"width: 909px\" class=\"wp-caption alignnone\"><a href=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche.png\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3024 size-full\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche.png\" alt=\"\" width=\"909\" height=\"178\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche.png 909w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche-300x59.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche-768x150.png 768w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche-100x20.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche-150x29.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche-200x39.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche-450x88.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche-600x117.png 600w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/FDA_Normsuche-900x176.png 900w\" sizes=\"auto, (max-width: 909px) 100vw, 909px\" \/><\/a><figcaption id=\"caption-attachment-3024\" class=\"wp-caption-text\">Valid version of 60601-1-2 at https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfstandards\/search.cfm<\/figcaption><\/figure>\n<p style=\"margin: 0in; font-family: Calibri; font-size: 11.0pt;\">So the 4th edition is currently valid there too.<\/p>\n<pre>Tip: The FDA also regularly publishes guidance documents that are helpful in understanding the agency&#039;s requirements and submitting the necessary documents and evidence.\r\n<\/pre>\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<h3>China<\/h3>\n<p>In China, the state-run CFDA (China Food and Drug Administration) is responsible for translating international standards into country-specific standards. You can find out the classification of standards using a search engine:<\/p>\n<p><a href=\"http:\/\/eng.sfda.gov.cn\/WS03\/CL0755\/\">http:\/\/eng.sfda.gov.cn\/WS03\/CL0755\/<\/a><\/p>\n<p>If you search for \u201c60601-1-2\u201d on the CFDA website, you will get a reference to the standard YY 0505-2012, which corresponds to IEC 60601-1-2:2004.<\/p>\n<figure id=\"attachment_3026\" aria-describedby=\"caption-attachment-3026\" style=\"width: 690px\" class=\"wp-caption alignnone\"><a href=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche.png\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-3026 size-full\" src=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche.png\" alt=\"\" width=\"690\" height=\"276\" srcset=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche.png 690w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche-300x120.png 300w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche-100x40.png 100w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche-150x60.png 150w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche-200x80.png 200w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche-450x180.png 450w, https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/CFDA_Normsuche-600x240.png 600w\" sizes=\"auto, (max-width: 690px) 100vw, 690px\" \/><\/a><figcaption id=\"caption-attachment-3026\" class=\"wp-caption-text\">Valid version of 60601-1-2 at http:\/\/eng.sfda.gov.cn\/WS03\/CL0755\/<\/figcaption><\/figure>\n<p>Another way to search for standards in China is on the SAC (Standardization Administration of China) website:<\/p>\n<p><a href=\"http:\/\/www.sac.gov.cn\/was5\/web\/outlinetemplet\/gjbzcx.jsp\">http:\/\/www.sac.gov.cn\/was5\/web\/\/outlinetemplet\/gjbzcx.jsp<\/a><\/p>\n<p>For example, you can display all medical standards by searching with the ICS number 11.040 (see also <a href=\"https:\/\/www.iso.org\/ics\/11.040\/x\/\">https:\/\/www.iso.org\/ics\/11.040\/x\/<\/a>).<\/p>\n<p>However, only official standards are listed there, known in China as GB standards. Since 60601-1-2, for example, is listed as an industry-specific standard (YY stands for medical technology), it cannot be found there.<\/p>\n<h3>Summary<\/h3>\n<p>In China, the 2nd edition of IEC 60601-1-2 is still valid, which contains significantly different test levels and requirements than the version of the standard applicable in the EU or the US. As you can see, it is important for all countries in which a device is to be approved to identify the relevant standards, as there can be considerable differences.<\/p>\n<p>Unfortunately, there isn&#039;t a single website that documents the requirements. Each country has its own approval procedures, and even if international standards apply, there may still be differences if different versions of the standards are still valid. If we can assist you with your approval, please feel free to call us or send us an inquiry.<\/p>\n<p>Best regards<br \/>\nMartin Bosch<\/p>","protected":false},"excerpt":{"rendered":"<p>Which standard must be observed for the approval of an electrical medical device? This article will explain how to determine this for the most important countries (i.e., the EU, USA, and China). The article refers to the 60601 family of standards\u2026<\/p>","protected":false},"author":2,"featured_media":3037,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[223,309,187,310,23,342,124,308],"class_list":["post-3005","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-normen","tag-60601-1","tag-cfda","tag-emv","tag-fda","tag-medizintechnik","tag-norm","tag-normen","tag-yy-0505-2012","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>Wo gilt welche Norm? - 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\/wo-gilt-welche-norm\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Wo gilt welche Norm? - MEDtech Ingenieur GmbH\" \/>\n<meta property=\"og:description\" content=\"Welche Norm muss f\u00fcr die Zulassung eines elektrischen Medizinger\u00e4ts beachtet werden? Wie man das f\u00fcr die wichtigsten L\u00e4nder (also EU, USA und China) herausfindet, soll in diesem Artikel beantwortet werden.\u00a0Der Artikel bezieht sich auf die 60601 Normenfamilie...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/medtech-ingenieur.de\/en\/wo-gilt-welche-norm\/\" \/>\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=\"2019-02-25T09:24:46+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-08-06T13:40:25+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2019\/02\/checklist-2945401_960_720.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"960\" \/>\n\t<meta property=\"og:image:height\" content=\"640\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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\\\/wo-gilt-welche-norm\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/wo-gilt-welche-norm\\\/\"},\"author\":{\"name\":\"Martin Bosch\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/#\\\/schema\\\/person\\\/4a6ce76ff044f5fc88a30484c695fd84\"},\"headline\":\"Wo gilt welche Norm?\",\"datePublished\":\"2019-02-25T09:24:46+00:00\",\"dateModified\":\"2021-08-06T13:40:25+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/wo-gilt-welche-norm\\\/\"},\"wordCount\":604,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/wo-gilt-welche-norm\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/medtech-ingenieur.de\\\/wp-content\\\/uploads\\\/2019\\\/02\\\/checklist-2945401_960_720.jpg\",\"keywords\":[\"60601-1\",\"CFDA\",\"EMV\",\"FDA\",\"Medizintechnik\",\"Norm\",\"Normen\",\"YY 0505-2012\"],\"articleSection\":[\"Normen\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/medtech-ingenieur.de\\\/wo-gilt-welche-norm\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/medtech-ingenieur.de\\\/wo-gilt-welche-norm\\\/\",\"url\":\"https:\\\/\\\/medtech-ingenieur.de\\\/wo-gilt-welche-norm\\\/\",\"name\":\"Wo gilt welche Norm? 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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":"Where does which standard apply? - 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\/wo-gilt-welche-norm\/","og_locale":"en_US","og_type":"article","og_title":"Wo gilt welche Norm? - MEDtech Ingenieur GmbH","og_description":"Welche Norm muss f\u00fcr die Zulassung eines elektrischen Medizinger\u00e4ts beachtet werden? 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