{"id":3179,"date":"2013-02-22T21:55:34","date_gmt":"2013-02-22T21:55:34","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3179"},"modified":"2013-02-22T21:55:34","modified_gmt":"2013-02-22T21:55:34","slug":"which-60601-1-3rd-ed-standard-applicable-for-fda","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2013\/02\/22\/which-60601-1-3rd-ed-standard-applicable-for-fda\/","title":{"rendered":"Which 60601-1, 3rd ed. Standard Applicable for FDA?"},"content":{"rendered":"

I have been asked in a variety of flavors if 3rd<\/sup> ed. of IEC 60601-1:2005 and\/or 3rd<\/sup> ed. + Amendment 1 (A1):2012 will be required by the FDA and when? The answer isn\u2019t exactly yes or no.\u00a0<\/span><\/p>\n

The end of the transition period for 2nd<\/sup> ed. of IEC 60601-1 is June 30, 2013.\u00a0 By July 1, 2013 I hope you will be using the 3rd<\/sup> ed. based standard for your FDA premarket submissions declarations of conformity.\u00a0 Are you ready for this transition period and where is the transition information located?<\/span><\/p>\n

The answer is that the IEC version of 60601-1 isn\u2019t a Recognized Consensus standard after the end of the transition period for 2nd<\/sup> ed. of IEC 60601-1. \u00a0FDA will allow the 2nd ed. of IEC 60601-1:1988 + A1: 1991 + A2:95 (Recognition Number 5-4, Recognition List #013) up til the end of the transition period of June 30, 2013 but the transition period isn\u2019t noted in this entry of the Recognized Consensus Standards list.\u00a0 So, where do you suppose it is located?\u00a0 One could search for a very long time and not come up with the answer, as the FDA database for Recognized Consensus Standards is not flexible when it comes to search terms.\u00a0 You need to know to search for the US national version of the standard, which is the AAMI ES version.\u00a0 Also, the entries for the 3rd<\/sup> ed based US national version of IEC 60601-1 vs. the 3rd<\/sup> ed. + A1 national version of IEC 60601-1 aren\u2019t in the database the same way.\u00a0 One is in the database as \u2018ES60601-1\u2019 and the other is \u2018ES 60601-1\u2019.<\/span><\/p>\n

So, as of now you can start to use the ANSI\/AAMI ES 60601-1:2005\/(R)2012 and C1:2009\/(R)2012, including the A2:2010\/(R)2012 (Consolidated Text), Medical electrical equipment – Part 1: General requirements for basic safety and essential performance <\/em>[Recognition Number 5-71, Recognition List #029] OR ANSI\/AAMI ES 60601-1:2005\/A1:2012 [Recognition Number 5-74, Recognition List #030] Recognition list #030 was issued on 15 Jan \u201913<\/a><\/strong>.\u00a0 Up to and thru June 30, 2013 you can also use the 2nd<\/sup> ed. of IEC 60601-1 [Recognition Number 5-4, Recognition List #013].\u00a0 In the Extent of Recognition section of both ES 60601-1 standards you will find a sub-section titled \u201cTransition:\u201d which states:<\/span><\/p>\n

\u201cFDA recognition of Edition 2:1988<\/span><\/strong> (A1:1991+A2:1995) of IEC 60601-1<\/span> <\/strong>is hereby superseded<\/span><\/strong> by recognition of ANSI\/AAMI ES60601-1:2005<\/span><\/strong>, Medical Electrical Equipment – Part 1: General requirements <\/span>
\n for basic safety and essential performance. FDA will accept declarations of conformity<\/span><\/strong>, in support of premarket submissions<\/span><\/strong>, to Edition 2:1988<\/span><\/strong> (A1:1991+A2:1995) of IEC 60601-1 until June 30, 2013<\/span><\/strong>. After<\/span><\/strong> this transitional period<\/span><\/strong>, declarations of conformity to Edition 2:1988<\/span><\/strong>(A1:1991+A2:1995) of the standard will not be accepted<\/span><\/strong>.\u201d<\/span>
\nNote, the text of the transition for both of the ES 60601-1 standards is the same.<\/span><\/p>\n

If you company needs support dealing with the IEC 60601 series of standards, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system <\/a>services\u00a0and more<\/a><\/strong>.\u00a0 Please feel free to contact us at Leo@EisnerSafetty.com<\/a><\/strong> or 503-244-6151.\u00a0 \u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

I have been asked in a variety of flavors if 3rd ed. of IEC 60601-1:2005 and\/or 3rd ed. + Amendment 1 (A1):2012 will be required by the FDA and when? The answer isn\u2019t exactly yes or no.\u00a0 The end of<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[45,61,15,16,54,161,919,920,162,921,922,41,47,404,926,163,74,847,941,27,9,942,13,617,943,944,53,945,946,94,22,330,174,175,149,861,947,5,352],"class_list":["post-3179","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-510k","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-aami","tag-aami-es-60601-1","tag-aami-es-60601-1-2005a1-2012","tag-aami-es-60601-105a112","tag-aami-es-60601-12005","tag-aami-es-60601-12005-a12012","tag-aami-es-60601-12005a12012","tag-aami-es60601-1","tag-aami-es60601-1c1","tag-amendment-1","tag-ansiaami-es-60601-12005a12012","tag-ansiaami-es60601-1","tag-cdrh","tag-consensus-standards","tag-declarations-of-conformity","tag-escnews","tag-fda","tag-fda-database","tag-iec","tag-iec-60601","tag-iec-60601-1-2nd-ed","tag-iec-60601-1-2nd-edition","tag-iec60601-1","tag-iec60601-1-2nd-ed","tag-iec60601-1-2nd-edition","tag-iec60601-1-3rd-ed","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-medical-electrical-equipment","tag-premarket-submissions","tag-risk-management","tag-transition-period"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3179","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=3179"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3179\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3179"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3179"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3179"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}