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@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

This blog reviews the release of Canadian Standard CAN/CSA C22.2 No. 60601-1:14 & where accessible (Safety Test Agencies vs Health Canada)

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

Good news!! Canada has recently released CAN/CSA C22.2 No. 60601-1:14 (:14 = 2014 year of release) which is their aligned Canadian National version of IEC 60601-1:2005 (3rd ed.) + Amendment 1:2012 (also known as IEC 60601-1, edition 3.1).  Standards Council of Canada’s (SCC) listing of this standard is titled: “CAN/CSA C22.2 NO. 60601-1:14 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (Adopted IEC 60601-1:2005, third edition, 2005-12, including amendment 1:2012, with Canadian deviations)”.  The SCC website for this standards points to 3 sources for obtaining the standard.  CSA Group, TechStreet, and StandardsStore.ca.  The standard is 1062 pages long because Canada requires English and French. CAN/CSA C22.2 No. 60601-1:2014 replaces CAN/CSA-C22.2 NO. 60601-1:08 (R2013) or CAN/CSA-C22.2 NO. 60601-1:08.  I have been advised that the National Deviations in this version of the standard should be very similar to CAN/CSA-C22.2 NO. 60601-1:08.

As of March 1, 2014 Canada is now accepting edition 3.1 with National Deviations under CAN/CSA C22.2 No. 60601-1:14.  I have been advised by CSA and a couple other Safety Test Agencies that they are starting to test to this standard.  Note that Health Canada has not updated their list of Recognized Standards for Medical Devices since Oct 2013 and so this standard is not in their current list of standards.  Currently Health Canada’s list only includes the 3rd ed. of IEC & CAN/CSA which on the list is either IEC 60601-1:2005 + Corrigendum 1: 2006 + Corr. 2:2007 or CAN/CSA-C22.2 NO. 60601-1:08.  I am sure you will be able to use this newer version of the standard for Health Canada submissions but I would check with your reviewer from Health Canada if you are submitting using this version of the standard what they may expect.  They may ask for a comparison between 3rd edition and ed. 3.1.  I would assume in their next update of the List of Recognized Standards Listing they will add this standard.

As with all the changes in standards I am asked when will each country and Safety Test Agency require the newer version of the standard and when will the older version be phased out.  At this point there are no firm dates and I will advise as soon as I find out more information on the subject.

If you need help with working with a Safety Test Lab to get a Certification to IEC 60601-1 or National Versions of the Standard, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).