FCC Part 15, 18 harmonized to a standard?

S

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

AllTheThings

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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.
 
S

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.
 
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emceng

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Swimming In The Soup said:
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.
Click to expand...

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!)
 
S

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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