{"id":6908,"date":"2021-05-21T00:17:21","date_gmt":"2021-05-21T00:17:21","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=6908"},"modified":"2022-06-12T18:02:45","modified_gmt":"2022-06-12T18:02:45","slug":"iec-60601-1-22020-ed-4-1-hidden-surprise","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2021\/05\/21\/iec-60601-1-22020-ed-4-1-hidden-surprise\/","title":{"rendered":"IEC 60601-1-2:2020 (Ed. 4.1) Hidden Surprise!"},"content":{"rendered":"\n
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Heads Up!<\/em><\/strong> – Updated 24 May 2021<\/em><\/strong><\/p>\n\n\n\n

Written by Bill Hardin and Leo Eisner<\/p>\n\n\n\n

Thx for all the great support from the LinkedIn, RAPS Forum, the standards and test lab communities that have provided feedback on this post.\u00a0 Turns out with all the good feedback we got from these communities we need to update this post as CISPR 11 Group 2 intentional radiators was included in the previous edition but you really need to be aware of RFID requirements<\/span>.<\/strong><\/p>\n\n\n\n

The FDA has been insisting that medical device, IVD and even implanted medical device manufacturers meet AIM 7351731 RFID immunity testing as part of their 510k\/PMA submissions.\u00a0 This test is onerous since it includes RF immunity at levels of up to 54V\/m, nearly twice the field strength (28V\/m) that the IEC 60601-1-2 table 9 requires, and would often result in design changes to increase RF immunity. <\/p>\n\n\n\n

From AIM 7351731:<\/p>\n\n\n\n

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IEC 60601-1-2:2020, edition 4.1, got fast tracked by the FDA since it contains new immunity tests (table 11<\/em><\/strong> – RFID requirements based on AIM 7351731 standard values) that they want manufacturers to do before submitting<\/em><\/strong>. The FDA has been accepting the IEC 60601-1-2:2020 table 11 test in lieu of AIM 7351731 testing<\/em><\/strong>, which is very good news<\/em><\/strong> as there are only two AIM 7351731 frequencies to be tested instead of all the test frequencies and test levels of Table 3 of the AIM 7351731 standard. <\/p>\n\n\n\n

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“IEC 60601-1-2:2020 (ed. 4.1 ) – Table 11 contains RFID requirements, FDA is accepting this in lieu of all the AIM 7351731 testing – This is good news<\/span><\/em><\/strong>“<\/p><\/blockquote><\/figure>\n\n\n\n

This 2020 version of IEC 60601-1-2 is still about three years out from taking effect in EU (with no grandfathering allowed) unless your Notified Body may expect \u2018State of the Art\u2019 in a shorter time period (some do require this) or your company will go with \u2018State of the Art\u2019 which is a requirement of the EU MDR 2017\/745 Annex I, Items 1 & 4, and per MDCG 2021-5<\/a>, but FDA went first by Recognizing the standard at the end of 2020.<\/p>\n\n\n\n

This blog previously erroneously stated that CISPR 11 Group 2 radiated emission limits had changed as part of the transition to IEC 60601-1-2:2020. They have not changed. So no redesign is needed for that but you still may need to redesign your product based on the RFID requirements.<\/p>\n\n\n\n

Join the conversation on LinkedIn<\/a> and add comments to the conversation there.<\/p>\n\n\n\n

Confused by these EMC, standards or regulatory issues? This is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more. Leo Eisner<\/a> is an expert on standards development and sit on many standards committees. Bill Hardin<\/a> is an EMC expert and a design expert that can help you thru the design process. Let us help you through this process. Need help with Essential Performance. Feel free to schedule a call with Leo www.EisnerSafety.com\/Schedule-Call\/<\/a> or contact Leo at Leo@EisnerSafety.com or through our contact form at https:\/\/eisnersafety.com\/contact_eisner_safety\/<\/a>.<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

IEC 60601-1-2:2014, 4th edition, references CISPR 11:2010 (a.k.a. EN 55011), had no radiated rf emissions requirements for group 2 devices (intentional radiators) between 150kHz and 30 MHz. This is the basis for all group 2 medical devices on the market today.
\nIEC 60601-1-2:2020, edition 4.1, got fast tracked by the FDA since it contains new immunity tests (table 11 – RFID requirements based on AIM 735131 standard values) that they want manufacturers to do immediately. In that 2020 standard, 60601-1-2 references CISPR 11:2015 + A1:2016 + A2:2019 version that inherits a new group 2 only RF radiated emissions test with limits that apply for 150kHz – 30 MHz.<\/p>\n","protected":false},"author":4,"featured_media":6909,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1353,1400,1421,1423,1344,1420,1370,1369,1347,1422,1368],"tags":[],"class_list":["post-6908","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-60601-1-2","category-60601-1-2-4th-ed","category-60601-1-2-ed-4-1","category-aim-7351731","category-fda","category-may-2021","category-mdr","category-medical-device-regulation","category-recognized-consensus-standards","category-rfid","category-state-of-the-art"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6908","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=6908"}],"version-history":[{"count":15,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6908\/revisions"}],"predecessor-version":[{"id":6934,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6908\/revisions\/6934"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6909"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=6908"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6908"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6908"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}