Are EEG electrodes considered as one applied part?

EMengineer

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#1
Hi,

I am a little confused and would like to ask about EEG electrodes, are they considered as one applied part or every single electrode is different applied part? Applied Leakage current test methods depends on how these electrodes are defined.

What I found in 601-1 3rd ed. is that "the APPLIED PART includes the electrodes and those parts of the patient cable that need to physically contact the patient in normal use" (explanation above A.7 pic.). It explains about ECG electrodes as APPLIED PART (not parts), but I assume in my situation it is the same.

Could someone confirm or deny it?
 
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MedMartin

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#2
Hi EMengineer,

yes, from my experience designing ECGs:
Your EEG electrodes are considered one applied part.

A device with e.g. two applied parts could be a fictive monitor with EEG and ECG inputs.
See also in IEC 60601-1 the explanation to subclause 3.8:
"c) If there is an applied part, there can be one or more patient connection(s). ..."

Best regards
Martin
 
#3
You may consider each electrode as distinct applied part, but in this case, that electrode shall be separated from the other AP (other electrodes) in terms of leakage current, dielectric test and creepage distances (see clause 8.5.2.1)
 
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