EMC for Medical Devices in Home Environment

tallu

Involved In Discussions
#1
FDA suggests using the 4th edition of IEC 60601-1-2 for Home Healthcare environments. In 4th edition the test levels for power frequency magnetic fields increased tenfold, to 30 A/m.

If company is seeking FDA clearance for class II device (tested against 3 A/m) and does not perform testing against 30 A/m they need to have (very strong?) rationale why the test was not performed.

Somehow the company should proof why testing against 3 A/m is acceptable for their device (through a study of published literature or environmental measurements).

What kind of rationale could safisty the FDA?

Any comments?
 
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#4
I think that this is a case where it is probably easier just to do the test.

Provided the test house has the equipment to do 30A/m then the test itself would probably only take 30 minutes.
And I would be surprised if your device showed any effects.
 
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