{"id":6819,"date":"2020-08-26T01:16:20","date_gmt":"2020-08-26T01:16:20","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=6819"},"modified":"2022-06-12T18:12:30","modified_gmt":"2022-06-12T18:12:30","slug":"iec-60601-1-amendment-2-just-released-join-for-a-webinar-on-changes-more","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2020\/08\/26\/iec-60601-1-amendment-2-just-released-join-for-a-webinar-on-changes-more\/","title":{"rendered":"IEC 60601-1 Amendment 2 Just Released &#8211; Join for a Webinar on Changes &#038; More"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">IEC 60601-1 Amendment 2 (IEC 60601-1:2005 +A1:2012 + A2:2020) has been in the making since 2015 (officially) along with the other published Amendments (IEC 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, &amp; 60601-1-12). It was published on <a rel=\"noreferrer noopener\" aria-label=\"20 August 2020 on the IEC website (opens in a new tab)\" href=\"https:\/\/bit.ly\/60601AmendsPublished\" target=\"_blank\">20 August 2020 on the IEC website<\/a> and you can obtain it either as a separate Amendment (A2) or as a consolidated edition (CSV). Unfortunately, you can&#8217;t obtain a red-line of the document showing from the previous edition.  I was hoping for that myself as so much easier to see the changes.  Also, I don&#8217;t recommend purchasing it from the IEC website as the standards there are usually too expensive to purchase.  I usually go to the Estonian Standards website but since the standard won&#8217;t be Harmonized for many years that won&#8217;t help.  So, I suggest going to your local standards distributor site such as <a rel=\"noreferrer noopener\" aria-label=\"IHS (opens in a new tab)\" href=\"https:\/\/global.ihs.com\/\" target=\"_blank\">IHS<\/a>, <a rel=\"noreferrer noopener\" aria-label=\"SAI Global (opens in a new tab)\" href=\"http:\/\/www.ili-info.com\/us\/\" target=\"_blank\">SAI Global<\/a>, or <a rel=\"noreferrer noopener\" aria-label=\"TechStreet (opens in a new tab)\" href=\"https:\/\/www.techstreet.com\/pages\/home\" target=\"_blank\">TechStreet<\/a> are some of the more common ones. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">So are you ready for all the changes of Amendment 2 of IEC 60601-1 and all the Amendments?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Join us for a <a href=\"https:\/\/lnkd.in\/gJ5wr9S\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"live free webinar (opens in a new tab)\">live free webinar<\/a> on an Insider\u2019s look at IEC60601 Amendments: detailed guidance from a committee member responsible for changes &#8211; Aug 27, 10 AM PT\/ 1 PM ET<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the&nbsp;IEC60601&nbsp;series is massive, creating a swell of confusion around understanding the updates &amp; how to transition for compliance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Greenlight Guru has teamed up with Leonard Eisner, the \u201cIEC 60601 Guy\u201d, of Eisner Safety Consultants to share his expertise on the topic, notably his contributions to The Amendments Project.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This in-depth webinar will cover clarifying details around the massive changes of the Amendments Project, provide guidance on updated <a rel=\"noreferrer noopener\" aria-label=\"standards already published (opens in a new tab)\" href=\"https:\/\/bit.ly\/60601AmendsPublished\" target=\"_blank\">standards already published<\/a>,&nbsp;insider knowledge into updated standards not yet published &amp; what to expect, &amp; how to prepare accordingly for the impact it will have on your firm and product lines.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>SOME OF THE CHANGES WE WILL COVER INCLUDE:&nbsp;<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Updates to IEC 60601-1 (Medical Electrical Equipment)<\/li><li>Updates to IEC 60601-1-2 (EMC)<\/li><li>Updates to IEC 60601-1-8 (Alarms)<\/li><li>Impacts of standard changes on:<ul><li>Design<\/li><li>Regulatory approvals (i.e. FDA vs EU Notified Body \u2013 current vs new standards)<\/li><li>Safety certifications<\/li><li>Labeling \/ markings \/ packaging<\/li><li>Tests\/ retesting<\/li><li>Essential Performance<\/li><li>Risk Management File<\/li><li>Usability Engineering File<\/li><li>Software Life Cycle Process<\/li><\/ul><\/li><li>Q&amp;A session<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>WHO SHOULD ATTEND?<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>R&amp;D Engineers and Management<\/li><li>Regulatory Affairs Professionals and Management<\/li><li>Quality Professionals and Management<\/li><li>Medical Device Executives<\/li><li>Clinical Affairs Professionals and Management<\/li><\/ul>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/lnkd.in\/gJ5wr9S\" target=\"_blank\" rel=\"noreferrer noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"511\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/08\/Screen-Shot-2020-08-13-at-11.12.14-AM-1024x511.png\" alt=\"\" class=\"wp-image-6800\" srcset=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/08\/Screen-Shot-2020-08-13-at-11.12.14-AM-1024x511.png 1024w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/08\/Screen-Shot-2020-08-13-at-11.12.14-AM-600x299.png 600w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/08\/Screen-Shot-2020-08-13-at-11.12.14-AM-300x150.png 300w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/08\/Screen-Shot-2020-08-13-at-11.12.14-AM-768x383.png 768w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/08\/Screen-Shot-2020-08-13-at-11.12.14-AM-1536x766.png 1536w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/08\/Screen-Shot-2020-08-13-at-11.12.14-AM.png 2000w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>IEC 60601-1 Amendment 2 (IEC 60601-1:2005 +A1:2012 + A2:2020) has been in the making since 2015 (officially) along with the other published Amendments (IEC 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, &amp; 60601-1-12). It was published on 20 August 2020 on the<\/p>\n","protected":false},"author":4,"featured_media":6800,"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":[1346,1325,1360,1359,1357,1350,1358,1353,1355,1354,1356,1351,1362,1352],"tags":[61,15,174,175,149],"class_list":["post-6819","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-60601-1-10","category-60601-1-11","category-60601-1-12","category-60601-1-2","category-60601-1-6","category-60601-1-8","category-60601-1-9","category-aug-2020","category-free-webinar","category-greenlight-guru","tag-60601-series","tag-60601-1","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6819","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=6819"}],"version-history":[{"count":4,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6819\/revisions"}],"predecessor-version":[{"id":6848,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6819\/revisions\/6848"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6800"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=6819"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6819"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6819"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}