{"id":1530,"date":"2010-03-17T20:14:11","date_gmt":"2010-03-17T20:14:11","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=1530"},"modified":"2010-03-17T20:14:11","modified_gmt":"2010-03-17T20:14:11","slug":"updated-en60601-series-faq-to-be-posted-on-cenelec-site-soon","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2010\/03\/17\/updated-en60601-series-faq-to-be-posted-on-cenelec-site-soon\/","title":{"rendered":"Updated EN60601 Series FAQ to be Posted on Cenelec site soon"},"content":{"rendered":"<p>Updated EN60601 Series FAQ in regard to the MDD &amp; AIMDDD to be posted on CENELEC website in the near future<\/p>\n<p>The document is an update to the current posted document issued 9 October 2009 on the <a title=\"See the Oct 9 2009 FAQ on EN 60601 series of standards in regard to the MDD &amp; AIMDD\" href=\"http:\/\/www.cenelec.eu\/Cenelec\/CENELEC+in+action\/Horizontal+areas\/ICT\/Collateral_standards_under_MDD_AIMD.htm\" target=\"_blank\" rel=\"noopener noreferrer\">CENELEC site<\/a><!--more--><\/p>\n<p>The newest document will add in a few critical issues including<\/p>\n<ul>\n<li>that with the publication of EN 60601-1:2006, compliance with EN 60601-1:1990 and its related collateral standards will no longer give \u2018presumption of conformity\u2019 with the European directives covered as of <strong>1 June 2012<\/strong>. \u00a0This date 2012 was confirmed by the CENELEC Technical Board in October 2009 (decision D135\/C228). Publication in the Official Journal of the European Union is necessary for this decision to enter into force. The publication of the 1 June 2012 date is expected in spring 2010.<\/li>\n<li>devices should not be presumed to be unsafe simply because they were designed to comply with <strong>EN 60601-1:1990<\/strong> when first introduced into the European market. Whether or not the safety of such devices represents the <strong>\u201cstate of the art\u201d<\/strong> can only be determined through the application of Risk Management according to EN ISO 14971 and especially with regard to Clause 9 thereof.<\/li>\n<li>For those medical devices for which a part 2 exists (i.e., a standard labeled EN 60601-2-x or EN 80601-2-x), the transition period for that part 2 is decisive. \u00a0If the transition period of the part 2 ends, for example, on 21 November 2011 then, after this date, compliance with the old (\u2018superseded\u2019) standard no longer gives the presumption of conformity with the Essential Requirements covered by the standard. In this situation, the 1 June 2012 date is not relevant.<\/li>\n<li>and more to be seen when issued on the CENELEC website. \u00a0I will post the link to the new FAQ when it is published.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Updated EN60601 Series FAQ in regard to the MDD &amp; AIMDDD to be posted on CENELEC website in the near future The document is an update to the current posted document issued 9 October 2009 on the CENELEC site<\/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":[61,15,16,62,35,36,63,64,12,65],"class_list":["post-1530","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-60601-series","tag-60601-1","tag-60601-1-3rd-ed","tag-60601-2-xx-particular-stds","tag-aimdd","tag-cenelec","tag-en60601","tag-en60601-1","tag-mdd","tag-part-2-60601-stds"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1530","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=1530"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1530\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=1530"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=1530"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=1530"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}