{"id":6799,"date":"2020-08-14T04:45:52","date_gmt":"2020-08-14T04:45:52","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=6799"},"modified":"2022-06-12T18:12:41","modified_gmt":"2022-06-12T18:12:41","slug":"insiders-look-at-the-iec-60601-amendments-detailed-guidance-from-committee-member-responsible-for-changes","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2020\/08\/14\/insiders-look-at-the-iec-60601-amendments-detailed-guidance-from-committee-member-responsible-for-changes\/","title":{"rendered":"Insider\u2019s look at the IEC 60601 Amendments: detailed guidance from committee member responsible for changes"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/bit.ly\/IEC601AmendsGGWebinar\"><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\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:18px\">It&#8217;s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:18px\">With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that the full scope of changes to the IEC 60601 series is massive, creating a swell of confusion around understanding the updates and how to transition for compliance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:18px\">We&#8217;ve teamed up with <a href=\"https:\/\/www.linkedin.com\/in\/leoeisnersafetyconsultants\" target=\"_blank\" rel=\"noreferrer noopener\">Leo Eisner<\/a>, the \u201cIEC 60601 Guy\u201d, of <a href=\"https:\/\/eisnersafety.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">Eisner Safety Consultants<\/a> to share his expertise on the topic, notably his contributions to The Amendment Project.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:18px\">This <a href=\"https:\/\/bit.ly\/IEC601AmendsGGWebinar\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"in-depth webinar (opens in a new tab)\">in-depth webinar<\/a> will cover clarifying details around the massive changes of the IEC 60601 Amendments, provide guidance on the updated <a rel=\"noreferrer noopener\" href=\"https:\/\/webstore.iec.ch\/advsearchform?&amp;q=60601-1&amp;RefHeader=IEC&amp;RefNbr=60601&amp;ComNumber=TC%2062\/SC%2062A&amp;ICSNumber=&amp;typepub=IS&amp;vap=CSV&amp;From=2020-07-20&amp;To=\" target=\"_blank\">standards already published<\/a>, insider knowledge into the updated standards not yet published and what to expect, and 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\" style=\"font-size:18px\"><strong>SPECIFICALLY THIS <a href=\"https:\/\/bit.ly\/IEC601AmendsGGWebinar\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"WEBINAR (opens in a new tab)\">WEBINAR<\/a> WILL COVER:<\/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>Impact 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\" style=\"font-size:18px\"><strong>Who Should <a href=\"https:\/\/bit.ly\/IEC601AmendsGGWebinar\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Attend (opens in a new tab)\">Attend<\/a>?<\/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 is-resized\"><a href=\"https:\/\/www.greenlight.guru\/\" target=\"_blank\" rel=\"noreferrer noopener\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.greenlight.guru\/hubfs\/images\/greenlight-guru\/greenlight-guru-logo.svg\" alt=\"greenlight-guru-logo\" width=\"225\" height=\"41\"\/><\/a><\/figure>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><strong>ABOUT GREENLIGHT GURU<\/strong><\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">Greenlight Guru is the only medical device quality management system (MDQMS) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/www.greenlight.guru\/\" target=\"_blank\">learn more<\/a>.<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><strong>ABOUT EISNER SAFETY CONSULTANTS<\/strong><\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"alignleft is-resized\"><a href=\"https:\/\/eisnersafety.com\/\" target=\"_blank\" rel=\"noreferrer noopener\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/mcusercontent.com\/d89a34a59f280a14e12228ea0\/images\/bda6d396-d2ea-4aae-b553-edfb7e313367.gif\" alt=\"\" width=\"78\" height=\"82\"\/><\/a><\/figure><\/div>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\">Eisner Safety Consultants supports your regulatory, quality systems, product safety,&nbsp;EMC, and engineering needs. Our experts speed your way to on-time product approvals&nbsp;via safety and regulatory agencies. We provide assistance with U.S., Canadian, European, &amp; other international regulations.&nbsp;You can see a full list of the service offerings from Eisner Safety Consultants by&nbsp;visiting their website to&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/eisnersafety.com\/\" target=\"_blank\">learn more<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>It&#8217;s becoming increasingly more difficult for medical device manufacturers and consultants to stay up to date with the proliferation of changes in the regulatory landscape. With several hundred changes written into the 60601-1 Amendment alone, suffice it to say that<\/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":[61,15,149],"class_list":["post-6799","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-devices"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6799","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=6799"}],"version-history":[{"count":16,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6799\/revisions"}],"predecessor-version":[{"id":6816,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6799\/revisions\/6816"}],"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=6799"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6799"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6799"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}