CSA Marking Requirements - IEC 60601-1 and CSA 622.2

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dwayneq

#1
I have a medical device that is electrical in nature. Testing has been completed per IEC 60601-1 Third Edition. It is my understanding that this meets the requirement for CSA marking. Is this true or does the device also need to be tested per CSA standards to recieve CSA marking?
 
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RA Guy

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#3
CSA is an organization, therefore if CSA has not tested the design or reviewed the testing of the design, then its my understanding that the CSA mark cannot be applied (i.e. ,there is NO self declaration permission). Their ability to do a review only of the design testing may be limited by the test lab you used to do it and how CSA recognizes them (i.e. best case is that they are a CSA global partner).

Over and above product testing, CSA would require a factory registration and inspection regeime be in place before the CSA mark can be applied.

It's been a while (over 3 years) since I've worked with 60601 devices, but generally I recall CSA using 60601 with little to no national deviations.

Also, CSA can be a global mark (i.e., they are accredited to perform safety testing to several national safety standards).

If the Canadian market is your objective, CSA is not the only recognized mark. Other providers (UL, Intertek, etc.) can provide equivalent certification services to be compliant for Canada.

Best approach is to call CSA and get the specifics based on your needs and what you have for test reports.
 
D

dwayneq

#4
Thanks RA Guy but I already understood that CSA would need to review the design and any testing performed before approving to apply the CSA mark. The question really was how CSA approves for application of their mark. Will they accept CE registration per EN IEC 60601-1 or do they require that they physically test the device or have another CSA approved lab test the device?
 
E

Eggsn

#5
Here's the link to the website: http://www.csa-international.org/service_options/

The thing is, CSA is only one of the symbols that hospitals in Canada look for. You can actually use (depending on the hospital) UL or TUV marks for your device. In essence you met the law or per country regulation that you meet the standard (I'd be sure to say EN 60601 instead of IEC 60601 though). The only problem is Canadian hospitals have their own regional requirements per province and one of them are these marks that they consider acceptable. In essence it's a marketing requirement more than anything. If your lab you tested to is ISO 17025 certified, then to me they are comparable to testing your product to EN 60601 according to how CSA or UL or TUV do it. Most labs now have to be certified to this in order to be considered a valid tester. In the old days, CSA/UL/TUV, etc. have more of a confidence because they are well known and they do things correctly by the book. More consistent than a random lab. As I said labs nowadays are getting certified but hospitals still have this idea that having the mark means better (in reality most of the time, testing is the same).

In some cases, it's much simpler to do the testing at CSA or TUV or UL, etc. and have them come and audit your facility rather than have them approve EACH device at EACH hospital where the product is going (which you can do also by the way). If you're in transition, I suggest doing the each device each hospital certification in the interim. Then plan on doing the witness testing or having them do the testing. Either way will give you the mark/symbols you need on your product for Marketing purposes.

I hope that helps.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#6
In terms of the testing, any laboratory that is accredited to ISO/IEC 17025:2005 by an ILAC Signatory body, and that has the CSA or the harmonized 60601 standards in the technical scope, can o the testing.

However, if you specifically need the CSA mark or the ULc mark or similar, then the testing must be done by one of them or an accredited lab acceptable to them.

Understand that if you go to CSA for their mark (same for most product certification bodies) you will NOT get a report until the certification body finishes their work, and the test report will be part of the approval to mark package. Now, the certification body must be accredited to ISO Guide 65, which CSA and several others are.

So, the question becomes the mark(s) that you need, and that will drive the testing.
 
D

dwayneq

#7
I understand what I am being told here and I believe I have a handle on it. What I am looking for is to determine if the testing already done on some product and/or future testing on other product can be leveraged for both EU and Canada. It appears from my research that if you do the proper testing per EN 60601-1 AND your test lab is accredited by the Standards Council of Canada (SCC) you are then able to mark your equipment with the CSA mark upon successful completion of testing.

If I am in error here please let me know. I am going to contact our test lab who performs our testing to confirm this.
 

Peter Selvey

Staff member
Super Moderator
#8
In principle yes, and I would add that the best way to ensure CSA will accept the report is to ask your test lab for a CB scheme report (they must accept a CB scheme report).

In the CB report, ask your test lab to include deviations for Canada (and US if you want a mark to cover you for the US as well).

In practice, CSA will review the report from the other test agency and may or may not ask for additional testing. In reality, there is a lot of engineering judgment in an IEC 60601-1 assessment, and there is no guarantee one agency will accept the judgement of another agency.

One way to avoid complication is to get CSA involved early and ask them to review the draft CB report and make comments then, and ask your local test lab to incorporate those comments into their final report. It smooths the path for the final CSA mark.
 
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