{"id":2747,"date":"2012-09-22T01:29:24","date_gmt":"2012-09-22T01:29:24","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=2747"},"modified":"2012-09-22T01:29:24","modified_gmt":"2012-09-22T01:29:24","slug":"csa-c22-2-no-601-1-m90-medical-electrical-equipment-standard-withdrawal-notice","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2012\/09\/22\/csa-c22-2-no-601-1-m90-medical-electrical-equipment-standard-withdrawal-notice\/","title":{"rendered":"CSA C22.2 No.601.1-M90 Medical Electrical Equipment Standard Withdrawal Notice"},"content":{"rendered":"<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">On 27 Aug 2012 CSA announced it is\u00a0transitioning the certification of Electro Medical Devices from\u00a0CAN\/CSA-C22.2 No.601.1-M90 AM1+AM2 to CAN\/CSA C22.2 No 60601-1-08. \u00a0<strong>The implementation date of the CAN\/CSA C22.2 No. 60601-1:08 standard is July 1, 2014.\u00a0<\/strong>\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"><!--more-->To see the full <a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2012\/09\/CSA-Transition-period-announcment-Healthcare-Equipment-CSA-3rd-ed.-transition-27-AUG-2012.pdf\">CSA Transition announcement click here<\/a>.<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">The \u00a0CSA class Numbers affected are:<\/span><\/p>\n<p style=\"padding-left: 30px;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">8750 01, MEDICAL ELECTRICAL EQUIPMENT\/SYSTEMS<\/span><br \/>\n<span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"> 8750 02, MEDICAL ELECTRICAL EQUIPMENT &#8211; Electromechanical Lifting Devices<\/span><br \/>\n<span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"> 8750 81, MEDICAL ELECTRICAL EQUIPMENT\/SYSTEMS &#8211; Certified to US Standards<\/span><br \/>\n<span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\"> 8750 82, MEDICAL ELECTRICAL EQUIPMENT &#8211; Electromechanical Lifting Devices &#8211; Certified to US Standards\u00a0<\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">The Important details of the transition are noted below:<\/span><\/p>\n<div>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">The CAN\/CSA-C22.2 No. 601.1-M90 (Canadian adopted IEC 60601-1 2nd edition) was published in 1990. This standard along with its amendments (AM1+AM2) have been successfully used for certification of electro-medical devices in Canada for many years and has been replaced by the CAN\/CSA-C22.2 No. 60601-1:08. The CAN\/CSA-C22.2 No. 601.1-M90 and AM1+AM2 standards shall be going through a phase out transition period as follows:<\/span><\/p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">New or alternative construction of medical devices can continue to be evaluated to the CAN\/CSA-C22.2 No. 601.1-M90 until June 30th , 2014<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">All new medical devices or alternative construction of previously certified medical devices shall be evaluated to CAN\/CSA C22.2 No 60601-1:08 after June 30th , 2014<\/span><\/li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">All medical devices already certified to the CAN\/CSA-C22.2 No. 601.1-M90 before July 1st, 2014 can continue to be manufactured with no change in construction.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: small;\">The CAN\/CSA-C22.2 No. 60601-1:08, published in Canada in 2008, is a Canadian adoption of the\u00a0IEC 60601-1, 3rd edition, which was published by IEC in 2005. This Risk Management based standard now addresses new additional requirements. Please contact us at <a href=\"mailto:Leo@EisnerSafety.com\">Eisner Safety Consultants<\/a> if you have any questions on the transition, we would be happy to assist you in your quest for proper compliance to the CSA standards.<\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>On 27 Aug 2012 CSA announced it is\u00a0transitioning the certification of Electro Medical Devices from\u00a0CAN\/CSA-C22.2 No.601.1-M90 AM1+AM2 to CAN\/CSA C22.2 No 60601-1-08. \u00a0The implementation date of the CAN\/CSA C22.2 No. 60601-1:08 standard is July 1, 2014.\u00a0\u00a0<\/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":[],"class_list":["post-2747","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2747","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=2747"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2747\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=2747"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=2747"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=2747"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}