Laboratory intentionally skipped the Magnetic Field Immunity test

FelipeSchneider

Involved In Discussions
Hello again,

Last year we submitted one of our medical devices to a third-party laboratory for EMC tests according to the IEC 60601-1-2 Edition 4.0 2014-02.
All results were good and we proceed to the 510K submission.

Then, during the FDA revision, they realized that the laboratory skipped the Magnetic Field Immunity test (EN/IEC 610004-8) arguing that "No components are sensitive to magnetic fields." And as expected, the FDA did not like it.

We did not realize that before, and now we need to make a really good reason for why this test was not performed.
So far I will base such argumentation on a small (but important) comment present on IEC 60601-1-2 Table 4 which states:
The IEC 61000-4-8 Magnetic Field Test only applies to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuits.
I believe that this will not be enough...
Have anyone gone through a similar problem?
 

Jaydub

Involved In Discussions
This is one reason we generally always do this test, even though virtually nothing fails.

Some other product standards have more a more explicit definition of magnetically sensitive components. For example CISPR 35 says "Applicable only to equipment containing devices intrinsically susceptible to magnetic fields, such as CRT monitors, Hall effect elements, electro-dynamic microphones, magnetic field sensors or audio frequency transformers."

Maybe you could say in your risk analysis that the device contains no magnetically sensitive components, such as CRT monitors, Hall effect elements, electro-dynamic microphones, magnetic field sensors or audio frequency transformers.

You may be aware that there is an ammendment that adds a proximity magnetic field immunity test. I don't know if the FDA is requiring it.
 

FelipeSchneider

Involved In Discussions
This is one reason we generally always do this test, even though virtually nothing fails.

Some other product standards have more a more explicit definition of magnetically sensitive components. For example CISPR 35 says "Applicable only to equipment containing devices intrinsically susceptible to magnetic fields, such as CRT monitors, Hall effect elements, electro-dynamic microphones, magnetic field sensors or audio frequency transformers."

Maybe you could say in your risk analysis that the device contains no magnetically sensitive components, such as CRT monitors, Hall effect elements, electro-dynamic microphones, magnetic field sensors or audio frequency transformers.

You may be aware that there is an ammendment that adds a proximity magnetic field immunity test. I don't know if the FDA is requiring it.

I think we have a chance...
I will add this to the letter that I will submit. Thanks Jaydub!
 

FelipeSchneider

Involved In Discussions
I work for a lab and we always recommend to do the testing. Takes 15 minutes, instead of hours (or days) of dealing with FDA pushback.

It was the labs decision to not make the test. I don't know exactly why they haven't performed it...
It was our fault not to check the lab's report
 

Sidney Vianna

Post Responsibly
Leader
Admin
It was the labs decision to not make the test. I don't know exactly why they haven't performed it...
It was our fault not to check the lab's report
The lab unilaterally decided a specified test was not relevant without consulting the customer first? That goes against good conformity assessment practices and ISO 17025 and you could take the issue to the lab accreditation body (assuming they are accredited). They should expedite a new test at no cost to you and apologize. It is that simple.
 
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