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Health Canada recognizes IEC 60601 3rd edition with Amendment 1

September 17, 2015

According to the Health Canada website, effective August 31st, 2015, Health Canada now recognizes both IEC 60601 3rd edition (ed.3.0) and 3rd edition with Amendment 1 (ed.3.1). The equivalent Canadian National Standard CAN/CSA-C22.2 NO. 60601-1:14 is also on the recognized standards list under “Electromedical.” This means that medical device manufacturers looking to sell their products in both Canada and the US can now improve efficiencies in the testing process by only testing to the requirements of 3rd Edition with Amendment 1. However, some markets have yet to recognize Amendment 1.

Health Canada has not yet announced a date of withdrawal for IEC 60601-1 ed.3.0.

Note that Health Canada did update the infusion pump particular standard, IEC 60601-2-24:20012-Ed.2.0 to require additional accuracy test results for low flow rates, depending on the intended use.

Several other collateral (part 1) and particular (part 2) standards associated with IEC 60601-1 2nd edition were removed during this update, many of which had already been replaced by their 3rd edition-aligned versions. To view all the changes, visit the Health Canada Subject: Announcement of Changes to the Therapeutic Products “Directorate's List of Recognized Standards for Medical Devices” online at: http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.php

For more information on UL’s global testing and certification services for IEC 60601, contact us or visit www.ul.com/60601

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