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Is IEC 60601-1-2 compliance/testing required for battery powered Class I Device

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Peter Selvey

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#2
In principle yes, but many tests would not be applicable.

It will also depend on what is inside the device, e.g. if it is just very low frequency analogue electronics, no CPU, digital electronics etc, then the tests might be almost non existent. I expect the ESD test is always applicable no matter how simple the device, but an EMC expert would know better.
 
#3
Another factor that would influence which tests are applicable and which are not is what leads are used with the device (if any). The length and function of each lead needs to be considered.
 
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