{"id":7230,"date":"2022-06-12T17:36:34","date_gmt":"2022-06-12T17:36:34","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7230"},"modified":"2022-06-13T21:18:52","modified_gmt":"2022-06-13T21:18:52","slug":"fda-swiftly-recognizes-aami-60601-amended-standards-30-may-2022","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2022\/06\/12\/fda-swiftly-recognizes-aami-60601-amended-standards-30-may-2022\/","title":{"rendered":"FDA Swiftly Recognizes AAMI 60601 Amended Standards 30 May 2022"},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards<\/a> that are referenced in my previous post of May 13, 2022. The AAMI standards were published in late March 2022. <\/p>\n\n\n\n

Not each Recognition was updated in the same way. Let me explain: <\/p>\n\n\n\n

The two Recognized Standards that show as being updated based on an updated \u201cdate of entry\u201d (upper right hand corner of the web page) of 05\/30\/2022 are & don’t have IEC equivalents in the Recognition db:<\/p><\/blockquote><\/figure>\n\n\n\n

FDA Recognition # 19-46<\/a> ANSI AAMI\u00a0ES60601-1:2005\/(R)2012 & A1:2012, C1:2009\/(R)2012 & A2:2010\/(R)2012 (Cons. Text) [Incl. AMD2:2021] \u2013 the<\/em> ANSI AAMI ES60601-1 AMD2:2021 is identical to Amendment 2:2020 of IEC 60601-1:2005<\/em> (post corrected 13 June)<\/strong><\/mark><\/em><\/p>\n\n\n\n

FDA Recognition # 19-47<\/a> ANSI AAMI\u00a0HA60601-1-11:2015 [Including AMD1:2021] \u2013 the ANSI AAMI HA60601-1-11 AMD1:2021 is identical to AMD1:2020 of IEC 60601-1-11:2015<\/em> (post corrected 13 June)<\/strong><\/mark><\/em><\/p>\n\n\n\n
\n
\n
\n
\n
\n
\n
\n\n\n\n

These 3 FDA Recognitions were NOT<\/strong> updated as a “Date of Entry” but the SIS were updated on 05\/30\/2022 which can be found @ the bottom left corner of the web page for each specific entry noted here. These 3 Recognitions include the ANSI AAMI IEC & IEC versions.<\/p><\/blockquote><\/figure>\n\n\n\n

FDA Recognition # 19-36<\/a> ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] –  the ANSI AAMI IEC 60601-1-2:2014 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-2:2014<\/em><\/p>\n\n\n\n

FDA Recognition # 5-131<\/a> ANSI AAMI IEC 60601-1-8:2006 and A1:20012 [including AMD2:2021] – the ANSI AAMI IEC 60601-1-8:2006 and A1:20012 including<\/em> AMD2:2021<\/em> is identical to Amendment 2:2020 of IEC 60601-1-8:2006<\/em><\/p>\n\n\n\n

FDA Recognition # 19-39<\/a> ANSI AAMI IEC 60601-1-12:2016 [Including AMD 1:2021] –  the ANSI AAMI IEC 60601-1-12:2016 Including AMD 1:2021 is identical to AMD1:2020 of IEC 60601-1-12:2014<\/em><\/p>\n\n\n

<\/p>\n\n\n

Need Help?<\/em><\/strong><\/h3>\n\n\n\n

Need help with 60601 standards (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner<\/a> is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. Feel free to schedule a call with Leo<\/a> or contact Leo at Leo@EisnerSafety.com or through our contact form<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

The FDA in a little over a month on 30 May 2022 (that is swift) has updated the Recognized Consensus database for the AAMI 60601 Amendmended Standards that are referenced in my previous post of May 13, 2022. The AAMI<\/p>\n","protected":false},"author":4,"featured_media":7290,"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":[1346,1325,1360,1359,1350,1358,1353,1421,1354,1481,1483,1344,1394,1484,1461,1347],"tags":[15,27,9,330,174],"class_list":["post-7230","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-60601-amendments","category-60601-1","category-60601-1-a2","category-60601-1-amendment-2","category-60601-1-11","category-60601-1-12","category-60601-1-2","category-60601-1-2-ed-4-1","category-60601-1-8","category-aami","category-ansi","category-fda","category-iec","category-june-2022","category-medical-device","category-recognized-consensus-standards","tag-60601-1","tag-escnews","tag-fda","tag-medical-device","tag-medical-device-industry"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7230","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=7230"}],"version-history":[{"count":37,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7230\/revisions"}],"predecessor-version":[{"id":7301,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7230\/revisions\/7301"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/7290"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7230"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7230"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7230"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}