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Medical Device EMC requirements - Canada - Testing to FCC part 18, EN 55011, EN 60601

amjadrana

Involved - Posts
#1
We are getting our product tested to FCC part 18, EN 55011 and EN 60601-1-2 for EMC compatibility.

Do we need to test for Canadian approval as well? What is the exact requirement for a class II medical device?

Thanks for your input.
 
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Al Rosen

Staff member
Super Moderator
#2
amjadrana said:
We are getting our product tested to FCC part 18, EN 55011 and EN 60601-1-2 for EMC compatibility.

Do we need to test for Canadian approval as well? What is the exact requirement for a class II medical device?

Thanks for your input.
I believe that 60601-1-2 is sufficient.
 

amjadrana

Involved - Posts
#3
EMC requirements for Canada medical devices

Thank you Al,

There is a standard ICES 001 Interference-Causing Equipment Standard for
Industrial, Scientific and Medical (ISM) Radio Frequency Generators from Industry Canada.

Is this standard applicable for medical devices? Do we have to get certification?

Thank you for your inputs
 
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