Canada - CSA C22.2 Medical Device Standards

S

Silvertabb

#1
A few years ago, we registered a Class III (US Class II) device and used UL60601-1 1st edition and the following as standards:

CSA C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety

CSA 22.2 No. 61010.1-4


We are modifying our device and will need to test our device again. Does anyone know if the two CSA standards listed above are still valid or they have been updated to other versions?

In case these standards have changed and/or new standards have been added for Class III devices, would you please include the the full title and date on which the standard become mandatory?



 
Elsmar Forum Sponsor
S

somerqc

#2
Re: Canada- CSA C22.2 Standards

if you go to www.csa-international.org you will be able to see these standards (newest version) as well as be able to purchase it if necessary.

I do not work for CSA but I do have to deal with their standards and have found their website to be an excellent source to answer these types of questions.

Also, you will be able to see if another standard has replaced it.
 
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