Defining the need to perform the Proximity magnetic fields immunity tests (IEC 61000-4-39) according to the IEC 60601-1-2 ed.4.1

[FelipeSchneider]

Hello, I am having some problems creating the IEC 60601-1-2 test plan for a Class I ME device, intended to be used only in a healthcare environment (not suitable for homecare). It is also relevant to mention that this is not a life-support device and we are aiming at the USA market, so the FDA and its requirements are in the game...

Specifically, the problem I am having is to point it out the need to perform the Proximity magnetic fields immunity tests (IEC 61000-4-39) according to the IEC 60601-1-2 ed.4.1.
Well, this standard mention that this test is only needed if the device has "magnetically sensitive components or circuits" AND if the risks associated with the failure of such components would lead to unacceptable risks.

I am an electrical engineer and I would say that this device does not have "magnetically sensitive components or circuits" for the specific frequencies that are excited during the IEC 61000-4-39 tests AND even if something fails no unacceptable risks would arise, however, I know that the FDA does not like a missing test, because I had problems before with the lack of a Power freq. magnetic field (EN/IEC 610004-8) during a previous submission.

My point is that there is a similar note for the EN/IEC 610004-8, where the IEC 60601-1-2 ed. 4.0 (that submission was according to the 4.0) states the following:

Applies only to ME EQUIPMENT and ME SYSTEMS with magnetically sensitive components or circuitry.

And the FDA did not like our reasoning.

So I would like to avoid problems this time and perform the IEC 61000-4-39 if necessary, but I don't know where in the device (it is not a small device) and this also has financial impacts.

Have anyone gone through a similar situation?

 

[emceng]

Start with defining where there are electronics in the EUT. You say it is large - for a large enclosure how close are electronics or cables to the case? A PCB 1 inch from the outside of the enclosure is definitely close to potential interference. Evaluate cables - are they magnetically shielded? You can narrow the areas tested by looking for things like this.

 

[FelipeSchneider]

I was missing a point in the standard: the IEC 60601-1-2 4.1 does bring a better explanation about the "sensitive components and circuits", it is present in Subsection 8.10.

The final point about this topic is that it is cheaper to do the test than to pay an engineer to try to justify why we haven't performed it and still incur a future FDA rejection.