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EMC/FCC part 15 test (NRTL - Nationally Recognized Testing Laboratories) required?

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#1
Hello everybody,

we have a class II medical device according to the FDA classification. We are now testing it for the 60601-1 in the UL labs. We also need an FCC part 15 test.

We are NOT thinking to do this test in the UL labs, I thought it was not a problem until I read a discussion here in the forum that make me think (maybe I misunderstand it) that the lab where we do the tests needs to be recognized by NRTL (nationally recognized testing laboratories). I made a quick search on NRTL site and the lab where we wanted to do the test is not there, however in their website they have an FCC accreditation. Do you think FDA will accept it anyway?
Thank you in advanced!

Emilia
 
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#2
Re: EMC/FCC part 15 test (NRTL - Nationally Recognized Testing Laboratories) required

Some thoughts:

1. There are only twenty or so listed NRTLs. I don't know if any of them include FCC Part 15 in their scope. You could review all of their scope lists. If none handle that requirement, clearly you can't be expected to get that testing done by an NRTL.

2. You could call FDA DSMICA (800-638-2041) and ask what's expected.

3. Many NRTLs are authorized to accept and certify testing results from accredited, but non-NRTL, labs. That's one way to get a highly specialized test certified by an NRTL.
 
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