Electrical safety (battery-powered medical device)

E

eEngineer

#1
Hello all,

Is it necessary in the EU to test the leakage current for a battery-powered medical device for compliance?

Thanks.
 
Elsmar Forum Sponsor
#2
In a word - yes.

But simple battery powered (Internal Electrical Power Source in the 60601 vernacular) devices may not require all of the 8 different leakage current tests, depending upon type of Applied Parts and any connections to other equipment.

It is worth remembering when studying the set-up diagrams of 60601-1 (figures 13 - 20) that the 'Earth' symbol shown refers to 'reference earth' - a common reference point and not necessarily supply earth. See table 5 and the rationale of clause 8.7.4.2

Welcome to the forums.
 
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