{"id":4099,"date":"2015-01-29T07:24:33","date_gmt":"2015-01-29T07:24:33","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4099"},"modified":"2015-01-29T07:24:33","modified_gmt":"2015-01-29T07:24:33","slug":"iec-60601-1-22014-4th-ed-what-is-the-impact-of-this-puzzle-on-your-product-design","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2015\/01\/29\/iec-60601-1-22014-4th-ed-what-is-the-impact-of-this-puzzle-on-your-product-design\/","title":{"rendered":"IEC 60601-1-2:2014 (4th ed.) What is the Impact of this Puzzle on Your Product Design?"},"content":{"rendered":"<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2015\/01\/shareasimage.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-medium wp-image-4113\" style=\"margin-top: -2px; margin-bottom: -2px;\" title=\"IEC 60601-1-2, 4th ed. What is the Impact of this Puzzle on Your Product Design?\" src=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2015\/01\/shareasimage-300x266.jpg\" alt=\"\" width=\"210\" height=\"186\" \/><\/a>This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4<sup>th<\/sup> ed. &amp; a discussion of timing of requirements in different world regions.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><a href=\"http:\/\/www.eisnersafety.com\/about_us\/associates\/\">Darryl Ray<\/a><\/strong>, of Darryl Ray EMC Consulting, provided the technical and regulatory content for this Blog Post.\u00a0 Thx for your insight Darryl!<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong><em>What is the impact of switching to IEC 60601-1-2, 4<sup>th<\/sup> edition on your electrical medical device?<\/em><\/strong>\u00a0 A partial listing is noted here:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">EMC must be addressed in the Risk Management documentation<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">A test plan &amp; report are required and the minimum contents specified<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Immunity\u00a0levels are based on use location (not the device type). The use locations are: 1) Professional Healthcare 2) Home Healthcare 3) Special<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Radiated Immunity levels vary depending on use location<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Radiated Immunity upper test frequency is now 2.7 GHz. Modulations modified<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Increased ESD test levels up to 15 kV air, 8 kV contact discharge<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The ESD test method on connectors is modified<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">New test: &#8220;Close Field\u00a0Proximity&#8221; &#8211; Radiated Immunity at 15 discrete frequencies, up to 28 V\/m, modified modulations<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">New Surge test for devices connected to 12V vehicle power<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Conducted Immunity levels are increased in some cases<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Voltage Dips &amp; Interrupts testing adds additional phase angles<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">AC input voltage requirements for all tests are clarified<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">The Potential Equalization Conductor must be connected during testing<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">If a device is damaged during immunity testing a new procedure has been added<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Magnetic Immunity test levels increased to 30 A\/m<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Modified labeling requirements<\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Etc\u2026.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">This new edition of the standard may have a significant impact on the design, testing and documentation of many medical devices.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><iframe loading=\"lazy\" src=\"https:\/\/www.youtube.com\/embed\/e3xFD4tgBnI?rel=0\" frameborder=\"0\" width=\"560\" height=\"315\"><\/iframe><\/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 required date for compliance can be difficult to determine, as the global requirements are not synchronized. It can be a bit a puzzle to solve to determine the mandatory global compliance dates,\u00a0as it depends on the specific device type, its production status and region the product is marketed. 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 submittals to the FDA, compliance to the 4<sup>th<\/sup> edition will be mandatory by April 1, 2017.\u00a0The FDA now\u00a0recognizes\u00a0the 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 2014. During this transition period the FDA also will accept 3<sup>rd<\/sup> edition of the standard as well up til April 1, 2017.<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)\u00a0which\u00a0is\u00a0the\u00a0required compliance date of EN 60601-1-2:2014, is estimated to December 31, 2018. This date will be finalized upon the information being published in the\u00a0European\u00a0Official Journal. The DOW date\u00a0is the end of\u00a0the grand fathering period for the previous version of the standard, EN 60601-1-2007. \u00a0After 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; Health Canada has yet to evaluate the 4th edition, therefore the date for\u00a0mandatory\u00a0compliance has not been\u00a0established.<br \/>\n<\/span><br \/>\n<span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"> <strong>Other Regions\u00a0<\/strong>&#8211; The compliance dates are highly variable driven by other international standards and local regulations.\u00a0For example, for a\u00a0particular standard (Part 2 particular standards IEC 60601-2-XX or IEC\/ISO 80601-2-XX) for a given device may have an undated\u00a0reference to IEC 60601-1-2. \u00a0In this case,\u00a0compliance to IEC 60601-1-2 4<sup>th<\/sup> edition would be linked to the\u00a0compliance date of the\u00a0particular standard with no grandfathering provisions. \u00a0Additionally, some\u00a0countries will NOT\u00a0accept 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 and you may still need to meet 3<sup>rd<\/sup> edition, as well.\u00a0 It really depends on what countries you plan to sell too and your regulatory strategy.<\/span><\/p>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">We have three EMC experts (<strong><a href=\"http:\/\/www.eisnersafety.com\/about_us\/associates\/\">Dan Hoolihan, Darryl Ray, &amp; Dan Modi<\/a><\/strong> &#8211; click the link to see their bio\u2019s) that have joined our ranks recently to help with the additional requests we are starting to see based on IEC 60601-1-2, 4<sup>th<\/sup> edition having a major impact on the redesign of most medical devices.\u00a0 We are seeing signs of a new wave of projects starting related to IEC 60601-1-2, 4<sup>th<\/sup> ed. and know that this new 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 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>\u00a0<em>Review of\u00a0PCB schematics &amp; layouts, enclosure design, mechanical construction, internal and external cabling design, etc.<\/em><\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Mitigations \u00a0&#8211;\u00a0<\/strong><em>Problem analysis, prototype fixes, support design engineering on redesigns, EMC component vendor liaison, etc.<\/em><\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Testing &amp; Documentation &#8211;\u00a0<\/strong><em>Perform testing (at customer location), testing oversight, generate test plans, review and generate test reports<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Risk Analysis &#8211;\u00a0<\/strong><em>Work with\u00a0the design and test teams to address Risk\u00a0Management as required by IEC 60601-1-2 4<sup>th<\/sup> edition<\/em><\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Standards &#8211;\u00a0<\/strong><em>Guidance and\u00a0interpretation of numerous EMC standards and regulations<\/em><\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Regulatory Engagement &amp; Support &#8211;\u00a0<\/strong><em>Provide support for\u00a0FDA, FCC, Health Canada, KFDA, ANVISA, CE Mark and other agency approvals<\/em><\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Medical Device EMC Labeling\u00a0<\/strong><a href=\"http:\/\/www.dray-emc.com\/available-training.html\"><strong>&#8211;<\/strong><\/a><strong>\u00a0<\/strong><em>Review\u00a0accompanying\u00a0documents for\u00a0compliance\u00a0to IEC\/EN 60601-1-2 requirements<\/em><\/span><\/li>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>Training\u00a0&#8211;\u00a0<\/strong><em>Training your staff on EMC design, testing and the new IEC 60601-1-2, 4<sup>th<\/sup> edition<\/em><\/span><\/li>\n<\/ul>\n<ul>\n<li><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\"><strong>EMC Lab Design, Construction and Setup\u00a0&#8211;\u00a0<\/strong><em>Anechoic chamber, shielded rooms &amp; general\u00a0lab design, vendor negotiations, project management, test equipment setup, etc.<\/em><\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: small; font-family: arial, helvetica, sans-serif;\">Are you ready for these big changes?\u00a0 We can help you with preparing for these big changes and on your EMC regulatory strategy. Contact us at <strong><a href=\"mailto:Leo@EisnerSafety.com\">Leo@EisnerSafety.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>This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4th ed. &amp; a discussion of timing of requirements in different world regions. Darryl Ray, of Darryl Ray EMC Consulting, provided the technical and regulatory<\/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":[61,27,9,10,93,88,89,91,13,218,1163,1204,1205,53,1206,1207,1208,22,330,174,175,149],"class_list":["post-4099","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-60601-series","tag-escnews","tag-fda","tag-fda-guidance","tag-home-healthcare-environments","tag-home-use","tag-home-use-environment","tag-home-use-med-dvcs","tag-iec","tag-iec-60601-1","tag-iec-60601-1-2","tag-iec-60601-1-2-4th-ed","tag-iec-60601-1-22014","tag-iec60601-1","tag-iec60601-1-2","tag-iec60601-1-2-4th-ed","tag-iec60601-1-22014","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4099","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=4099"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4099\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=4099"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=4099"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=4099"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}