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CAN/CSA C22.2 No. 60601 Standard Changes

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





Withdrawal of CAN/CSA C22.2 No. 601.1-M90+A1+A2

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

Recently Released CAN/CSA C22.2 No. 60601-1:14

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.  Per our associate Christine Ruther recently indicated that “Health Canada…is open to receiving submissions that reference A1.  If A1 is applied, Health Canada would appreciate a gap analysis to identify where the differences in the versions might impact the safety and effectiveness of the device to aid the person reviewing the file.  (Such an analysis can be readily created.)”  This gap assessment should be conducted between the currently Recognized standard such as CAN/CSA C22.2 No 60601-1:08 against the CAN/CSA C22.2 No. 60601-1:14.

More details about these two subjects are noted in the below links that have been previously posted on our site:

CSA C22.2 No.601.1-M90 Medical Electrical Equipment Standard Withdrawal Notice

CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released

If you need additional support for IEC or CAN/CSA C22.2 No. 60601-1, 3rd edition + A1 email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).