Canada Electrical Equipment Marking Language Requirements

L

leroybrown

Quick question regarding label marking on our MEE -

Are medical devices under the jurisdiction of the inspection department per the Canadian Electrical Code, C22.1-12 rule 2-024? See attached statement.

We are trying to determine whether or not we are required to include French on a warning label on our MEE. Our authorization to mark in Canada is being withheld until we comply, but we aren't sure if medical devices are covered under this language requirement.

Any help is greatly appreciated!!
 

Attachments

  • 12 06 (Jun) 18 - CACES Letter - Equipment Markings.pdf
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Eamon

Involved In Discussions
There really are two questions here, I think.

First, apropos of jurisdiction.

Medical devices qua medical devices are under the jurisdiction of Health Canada.

However, you seem to be referring to a requirement stemming from the electrical code, and thus applying more broadly than medical devices, to anything that connects to mains.

Health Canada, as titular regulator of medical devices, would not independently be enforcing an electrical code requirement - they would leave that up to the provincial safety boards. Here, in any case, you are not here dealing with HC, but with your marking body. It is their mark you are applying to use, and therefore, one would think, their choice of applicable criteria. I don't find it surprising that a marking body is concerned about electrical code compliance.

Note that even if they have certified your MEE to 60601-1, this requirement might well not have arisen within the scope of the 60601-1 certification. Instead, it might be applied specifically when evaluating for marking for a particular national market. Perhaps this is what you have encountered.

Second, apropos of French. Canada is officially bilingual. While I have not looked into this particular case, from living here I can assure you that official bilingualism generally imposes a requirement to label things in both official languages.

I'm not in a position to quote regulations chapter and verse, but I hope this helps nonetheless.

Eamon
 
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Peter Selvey

Leader
Super Moderator
Just to confirm what Eamon said, I heard also that the Canadian Electrical Code (CEC) itself is just a private standard and not law. It is left to each province and territory to decide what to do. But I found a UL website that says CEC Part I is adopted uniformly.

The reference to C22.2 No. 0 could be a bit misleading. Years ago UL insisted on doing a 40A earthing test according to C22.2 No. 0, even though the medical standard only requires 25A. I researched and found this "No. 0" is a background standard, and there was a clear statement (Clause 1.5.2) that where there are conflicts between the general standard and the individual standard, the requirements of the individual standard (i.e. the medical standard) take precedence.

I don't have access to the latest versions, but I suspect the same clause would have to exist to avoid conflict.

In the version of CAN/CSA-C22.2 No. 60601-1:08 (IEC 60601-1:2005+deviations) I have it says the language for the instructions for use should be appropriate for the intended operator, and there is no national deviations. That would take precedence over any requirement from C22.2 No. 0.

However, for the equipment marking, there is no statement about language so C22.2 No. 0 might be effective. As I understand, for marking there is a preference anyhow for symbols to be used to avoid trouble with translations. And keep in mind the scope, just because there is text on the device doesn't mean it needs to be translated. Only text which is relevant to compliance with the standards.

Upshot is, you need to read the standards, not a quick summary.
 
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