FCC Part 15, 18 harmonized to a standard?

Swimming In The Soup

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Hi, I have been trying to find a suitable ISO standard that is harmonized to FCC Part 15 and 18 for a class 2 Medical Device.
I know the general and particular standards for MD but we are confused on the FCC approach. Should we just test to the FCC parts? Any advice is appreciated.
 

AllTheThings

Involved In Discussions
Generally, I've asked EMC labs to test to the combined lower "curves" of FCC and CISPR requirements. That way, I can just ignore the differences and know I am passing in my target markets.

Unfortunately, I don't believe there is any harmonized standard between US/FCC and EU/IEC/CISPR requirements.
 

Swimming In The Soup

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I called and spoke to FDA. Other than a Q-Sub, I was directed to the consensus standards which I have looked at already. There are no clauses from the FCC section of the CFR.

I believe the 60601-1-2 is required here as medical device regulation supersedes other regulation for medical devices.

Agreement? Other thoughts? Thanks.
 

emceng

Starting to get Involved
I called and spoke to FDA. Other than a Q-Sub, I was directed to the consensus standards which I have looked at already. There are no clauses from the FCC section of the CFR.

I believe the 60601-1-2 is required here as medical device regulation supersedes other regulation for medical devices.

Agreement? Other thoughts? Thanks.

Medical devices that don't have a radio are exempt from Part 15, but not Part 18. For a Group 2 device under EN 55011 FCC Part 18 will also apply. Note that Class 2 and Group 2 are different. Group 2 under EN 55011 means the product uses RF energy for something besides communication - RF diathermy, heating, etc.

There are no harmonized ISO standards for the FCC. Part 15 for unintentional uses ANSI C63.4 as the test method, and Part 18 uses MP-5 (which is slated to be replaced in a few years since it was written in 1986!)
 

Swimming In The Soup

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Thanks. It would be Group 2 then as it uses RF to generate a plasma field. We have a non-medical machine that will be tested to C63.4. I guess for US there isn't much difference for radiators. Thanks again for the input.
 
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