{"id":6007,"date":"2018-05-02T00:08:57","date_gmt":"2018-05-02T00:08:57","guid":{"rendered":"https:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=6007"},"modified":"2022-06-12T18:15:54","modified_gmt":"2022-06-12T18:15:54","slug":"are-you-ready-for-iec-60601-1-2-4th-ed-emc","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2018\/05\/02\/are-you-ready-for-iec-60601-1-2-4th-ed-emc\/","title":{"rendered":"Are you Ready for IEC 60601-1-2, 4th ed. (EMC)?"},"content":{"rendered":"<div style=\"text-align: center;\"><iframe loading=\"lazy\" src=\"https:\/\/www.youtube.com\/embed\/bdy9QyUeoSs?rel=0\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/div>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">1 January 2019 is not far away and the 4th edition of the standard may have a significant impact on the design, testing and documentation of many medical devices that have not met this standard yet.&nbsp; For the US (FDA), EU (CE Mark for Medical Devices), and Canada (Health&nbsp;Canada) this is the final transition date to meet this requirement.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><em>When do we have to comply with IEC 60601-1-2 4<sup>th<\/sup> edition?<\/em><\/strong><\/span><br \/>\n<span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The three countries\/regions of the world (US, EU, &amp; Canada) have synchronized the date of compliance to 1 January 2019.&nbsp; This was not always the case as FDA modified their transition date several times before settling on this date.&nbsp; Realize that most other countries are requiring 3rd edition and some are still back on 2nd edition of IEC 60601-1-2.&nbsp; A brief summary by region is shown below:<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>USA<\/strong> &#8211; For new submissions to the FDA, compliance to the 4<sup>th<\/sup> edition will be mandatory by January 1, 2019.&nbsp;The FDA now&nbsp;recognizes&nbsp;the 4<sup>th<\/sup> edition and encourages manufactures to comply with the 4<sup>th<\/sup> edition for new device submittals and this can be seen in the updated Final Guidance for Home Use Medical Devices that the FDA re-issued in November 24, 2014 and updated on August 8, 2016 to update the transition date of ANSI\/AAMI\/IEC 60601-1-2. During this transition period the FDA also will accept 3<sup>rd<\/sup> edition of the standard as well up til December 31, 2018.<br \/>\n<\/span><br \/>\n<span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"> <strong>European Union<\/strong> &#8211; The Date of Withdrawal (DOW)&nbsp;which&nbsp;is&nbsp;the&nbsp;required compliance date of EN 60601-1-2:2014, is December 31, 2018.&nbsp; The DOW date&nbsp;is the end of&nbsp;the grand fathering period for the previous version of the standard, EN 60601-1-2007 (third edition). &nbsp;After that date, all devices including legacy devices sold to the EU must comply with the new standard.<br \/>\n<\/span><br \/>\n<span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"> <strong>Canada<\/strong> &#8211; In Health Canada&#8217;s List of Recognized Standards&nbsp;it states that until December 31, 2018 it will accept Declarations of Conformity to either 3rd or 4th edition of IEC 60601-1-2.&nbsp;&nbsp;After which declarations of conformity to IEC 60601-1-2:2007 &#8211; Ed 3.0 will not be accepted.<br \/>\n<\/span><br \/>\n<span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"> <strong>Other Regions&nbsp;<\/strong>&#8211; The compliance dates are highly variable driven by other international standards and local regulations.&nbsp;For example, for a&nbsp;particular standard (Part 2 particular standards IEC 60601-2-XX or IEC\/ISO 80601-2-XX) for a given device will most likely at this time reference IEC 60601-1-2, 4th edition if the country is using the most current IEC 60601-2-XX or IEC\/ISO 80601-2-XX standard but otherwise may be referring to an older version of the IEC 60601-1-2. &nbsp;&nbsp;Additionally, some&nbsp;countries will NOT&nbsp;accept the 4th edition at this time to further complicate this issue.<br \/>\n<\/span><br \/>\n<span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"> <em>Please note that compliance dates of standards are driven by their national regulatory bodies (i.e. US = FDA, Canada = Health Canada, etc.) and are subject to change.<\/em><\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"> It is strongly recommended to comply with the requirements of IEC 60601-1-2 4<sup>th<\/sup> edition for all new medical device designs going into the US, EU, and Canada.&nbsp; You may still need to meet 3<sup>rd<\/sup> edition, as well.&nbsp; It really depends on what other countries you plan to sell too and your regulatory strategy.&nbsp; We can help put a test plan and test strategy together to deal with testing to 3rd &amp; 4th edition.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">We have several EMC experts that can assist our clients with the transition to&nbsp;IEC 60601-1-2, 4<sup>th<\/sup> edition as it is having a major impact on the design, testing and documentation required of most medical devices.&nbsp; We are seeing signs of a new wave of projects related to IEC 60601-1-2, 4<sup>th<\/sup> ed. and know that this edition will have a big impact on electrical medical devices.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The EMC services we can provide your medical device company are listed below, for your convenience, in addition to our other regulatory, product safety, engineering, and quality system consulting services.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Services Available<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Design &#8211;<\/strong>&nbsp;<em>Review of&nbsp;PCB schematics &amp; layouts, enclosure design, mechanical construction, internal and external cabling design, etc.<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Mitigations &nbsp;&#8211;&nbsp;<\/strong><em>Problem analysis, prototype fixes, support design engineering on redesigns, EMC component vendor liaison, etc.<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Witness Testing &amp; Documentation &#8211;&nbsp;<\/strong><em>Perform testing oversight, generate test plans, review and generate test reports<br \/>\n<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Risk Analysis &#8211;&nbsp;<\/strong><em>Work with&nbsp;the design and test teams to address Risk&nbsp;Management as required by IEC 60601-1-2 4<sup>th<\/sup> edition<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Standards &#8211;&nbsp;<\/strong><em>Guidance and&nbsp;interpretation of numerous EMC standards and regulations<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Regulatory Engagement &amp; Support &#8211;&nbsp;<\/strong><em>Provide support for&nbsp;FDA, FCC, Health Canada, KFDA, ANVISA, CE Mark and other agency approvals<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Medical Device EMC Labeling &#8211;<\/strong><strong>&nbsp;<\/strong><em>Review&nbsp;accompanying&nbsp;documents for&nbsp;compliance&nbsp;to IEC\/EN 60601-1-2 requirements<br \/>\n<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Training&nbsp;&#8211;&nbsp;<\/strong><em>Training your staff on EMC design, testing, IEC 60601-1-2, 4<sup>th<\/sup> edition, and differences between 3<sup>rd<\/sup>&nbsp;and 4<sup>th<\/sup> editions<\/em><\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Are you ready for these changes, do you have the bandwidth to deal with these changes?&nbsp; We can help you with preparing for these changes and on your EMC regulatory strategy. Contact us at <strong><a href=\"mailto:Leo at EisnerSafety dot com\">Leo at EisnerSafety dot com<\/a><\/strong> or call Leo at 503-245-6558 to arrange an EMC project to help support your medical electrical device EMC needs.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>1 January 2019 is not far away and the 4th edition of the standard may have a significant impact on the design, testing and documentation of many medical devices that have not met this standard yet.&nbsp; For the US (FDA),<\/p>\n","protected":false},"author":4,"featured_media":6461,"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":[1353,1400,1365,1344,1393,1401],"tags":[39,1204,1205],"class_list":["post-6007","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-60601-1-2","category-60601-1-2-4th-ed","category-eu","category-fda","category-health-canada","category-may-2018","tag-60601-1-2","tag-iec-60601-1-2-4th-ed","tag-iec-60601-1-22014"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6007","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=6007"}],"version-history":[{"count":3,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6007\/revisions"}],"predecessor-version":[{"id":6859,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6007\/revisions\/6859"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6461"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=6007"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6007"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6007"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}