EMC for Medical Devices in Home Environment

T

tallu

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?
 
Michael Malis

Michael Malis

Quite Involved in Discussions
Without knowing details of your product, it is hard to provide a rationale, because there are questions about safety.
 
P

Pads38

Moderator
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.
 
L

lu000583

fda suggest to 4th on 2016，currently, 2007 version is still valid
 
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