{"id":3871,"date":"2014-05-28T22:44:55","date_gmt":"2014-05-28T22:44:55","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=3871"},"modified":"2014-05-28T22:44:55","modified_gmt":"2014-05-28T22:44:55","slug":"cancsa-c22-2-no-60601-standard-changes","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2014\/05\/28\/cancsa-c22-2-no-60601-standard-changes\/","title":{"rendered":"CAN\/CSA C22.2 No. 60601 Standard Changes"},"content":{"rendered":"

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Reminder<\/span> post – withdrawal of CAN\/CSA C22.2 No. 601.1-M90+A1+A2 is on June 30, 2014 & CAN\/CSA-C22.2 No. 60601-1:14 was recently published<\/span><\/p>\n

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Withdrawal of CAN\/CSA C22.2 No. 601.1-M90+A1+A2<\/span><\/h4>\n

After June 30, 2014 you will no longer be able to use\u00a0CAN\/CSA C22.2 No. 601.1-M90+A1+A2 for a Canadian Certification Project and it will be replaced by use of either\u00a0CAN\/CSA C22.2 No 60601-1:08 (equivalent to 3rd edition of IEC 60601-1with Canadian National Deviations) or\u00a0CAN\/CSA C22.2 No. 60601-1:14 (equivalent of IEC 60601-1, 3rd edition + A1 + Canadian National Deviations).<\/span><\/p>\n

Recently Released CAN\/CSA C22.2 No. 60601-1:14<\/span><\/h4>\n

CAN\/CSA C22.2 No. 60601-1:14 was published a couple months ago and is still not added into Health Canada’s List of Recognized Standards. \u00a0Per our associate Christine Ruther recently indicated that “Health Canada…is open to receiving submissions that reference A1.\u00a0 If A1 is applied, Health Canada would appreciate a gap analysis to\u00a0identify where the differences in the versions might impact the safety and effectiveness of the device to aid the person reviewing the file.\u00a0 (Such an analysis can be readily created.)” \u00a0This gap assessment should be conducted between the currently Recognized standard such as\u00a0CAN\/CSA C22.2 No 60601-1:08 against the\u00a0CAN\/CSA C22.2 No. 60601-1:14.<\/span><\/p>\n

More details about these two subjects are noted in the below links that have been previously posted on our site:<\/span><\/p>\n

CSA C22.2 No.601.1-M90 Medical Electrical Equipment Standard Withdrawal Notice<\/a><\/strong><\/span><\/p>\n

CAN\/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released<\/a><\/strong><\/span><\/p>\n

If you need additional support for IEC or CAN\/CSA C22.2 No. 60601-1, 3rd edition + A1 email Leo Eisner at\u00a0Leo@EisnerSafety.com<\/a><\/strong>, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly\/EisnerSafetyConsultants<\/a><\/strong>).<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Reminder post – withdrawal of CAN\/CSA C22.2 No. 601.1-M90+A1+A2 is on June 30, 2014 & CAN\/CSA-C22.2 No. 60601-1:14 was recently published        <\/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":[15,16,59,1151,403,404,1166,1167,1168,1169,27,100,13,218,53,94,60,22,330,174,149,1170],"class_list":["post-3871","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-60601-1","tag-60601-1-3rd-ed","tag-60601-1-3rd-ed-amendment-1","tag-1151","tag-a1","tag-amendment-1","tag-cancsa-c22-2-no-60601-114","tag-canadian-national-deviations","tag-ed-3-1","tag-edition-3-1","tag-escnews","tag-health-canada","tag-iec","tag-iec-60601-1","tag-iec60601-1","tag-iec60601-1-3rd-ed","tag-iec60601-1-3rd-ed-amendment-1","tag-medical","tag-medical-device","tag-medical-device-industry","tag-medical-devices","tag-standards-council-of-canada"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3871","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=3871"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/3871\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=3871"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=3871"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=3871"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}