{"id":9168,"date":"2019-03-18T08:38:38","date_gmt":"2019-03-18T07:38:38","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9168"},"modified":"2023-01-24T14:59:25","modified_gmt":"2023-01-24T13:59:25","slug":"canada-updated-list-of-recognized-standards-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2019\/03\/18\/canada-updated-list-of-recognized-standards-for-medical-devices\/","title":{"rendered":"CANADA: updated list of recognized standards for medical devices"},"content":{"rendered":"\n<p>With the latest update of the list of recognized standards (for 2019), Health Canada has eliminated <strong>eight <\/strong>standards and added <strong>fourteen <\/strong>new ones.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2019\/03\/CANADA-aggiornato-lelenco-degli-standard-riconosciuti-per-i-dispositivi-medici-1024x536.png\" alt=\"\" class=\"wp-image-9162\"\/><figcaption><em>Updated list of recognized standards for medical devices in Canada<\/em><\/figcaption><\/figure>\n\n\n\n<p>The <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/standards\/list-recognized-standards-medical-devices.html\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">new list of recognized standards<\/a> came into force officially on February 25, 2019.<\/p>\n\n\n\n<p>In addition to adding and deleting, Health\nCanada has substantially updated <strong>thirteen<\/strong>\nstandards, including: <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>IEC 62304:2015  regarding software life cycle processes of medical device software, and  <\/li><li>IEC 60601-1-3:2013, IEC 60601-2-37:2015, IEC 60601-2-44:2016 e IEC 60601-2-54:2015 on electromedical equipment.<\/li><\/ul>\n\n\n\n<p>Furthermore, with regard to electromagnetic compatibility, effective December 31, 2018, compliance with the IEC 60601-1-2:2007 &#8211; 3.0 Edition standard is no longer accepted by the Canadian regulatory Authority, the <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/standards\/list-recognized-standards-medical-devices.html\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">fourth edition<\/a> having become effective on the said date. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>With the latest update of the list of recognized standards (for 2019), Health Canada has eliminated eight standards and added fourteen  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-9168","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CANADA: updated list of recognized standards for medical devices - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2019\/03\/18\/canada-updated-list-of-recognized-standards-for-medical-devices\/\" 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