The voltage difference you will need to review and do a gap analysis. The voltages may be referenced in the requirements. I don't have access to these standards, not my expertise.
In response to the CFR 47 2017 ... again not my expertise I don't get into detailed EMC test planning.
------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 27-Jun-2020 13:41
From: Anonymous Member
Subject: IEC- EN standards Health Canada
This message was posted by a user wishing to remain anonymous
Hi Leonard ,
Thank you so much for your explanation. I was wondering if the voltage difference could make these comparisons irrelevant. ( Canada on 110 V and EU 220 V) will that be a problem?
Also, if the testings were done per CFR 47 2017 Part 15.107 Part 15.109 ( EN 55022) will that be good enough to explain in the Health Canada application.
Thanks
Original Message:
Sent: 27-Jun-2020 03:39
From: Leonard Eisner
Subject: IEC- EN standards Health Canada
As Franky mentioned it is likely there are few if any difference but you do want to make sure to check for differences between the standards from the European Norms to the IEC level documents. The most common differences would be for a safety standard component safety standard requirements might be a EN standard requirement in the EN standard whereas in the IEC standard it would be an IEC standard so there could be differences there. For EMC you will need to look closely to see what the differences are and talk to the test lab you are working with. Not all EMC test houses have the knowledge for this comparison, only the better top tier ones really do.
------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
Original Message:
Sent: 26-Jun-2020 10:40
From: Anonymous Member
Subject: IEC- EN standards Health Canada
This message was posted by a user wishing to remain anonymous
Franky and Richard - Thank you so much for your help.
Original Message:
Sent: 26-Jun-2020 03:32
From: Richard Vincins
Subject: IEC- EN standards Health Canada
Anon,
Keep in mind the standards you are citing are "EN" standards - European Norm. These are only applicable to the European Union. The IEC standard is the international version. As Franky indicated you have to take both standards into consideration ... if you are CE Marking the device for Europe then you need to apply the EN standards. Health Canada recognises the IEC standard because there is not a CSA standards issued against that EMC standard. You should have a discussion with your testing laboratory issuing the report to ensure it also covers IEC which would be appropriate for Canadian requirements.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 26-Jun-2020 02:18
From: Franky Dubois
Subject: IEC- EN standards Health Canada
Hello,
I would make a comparison between the HC recognized standard and the EN standard, to indicate that the testing was also compliant with the recognized IEC standards. Differences between both are relatively small.
In future it is recommended to take both standards in consideration for the performed tests
Greetings,
Franky
------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
Original Message:
Sent: 25-Jun-2020 14:56
From: Anonymous Member
Subject: IEC- EN standards Health Canada
This message was posted by a user wishing to remain anonymous
Hi All,
Can someone please comment .
I have a test report for EMC stating compliance to EN 61326-1:2013 / EN 61326-2-6 : 2013. Can I use these for Health Canada submissions ? HC guidance only recognizes IEC 61326‐2‐6:2012‐Ed.2.0/IEC 61326‐1:2012‐Ed.2.0 ?
Will HC accept this ?
Thanks!