IEC 60601-2-2 - Defib-proof test amendment to base standard

#1
Hello,

60601-2-2 changes the defib proof test to limit test condition to be:

1. Common mode
2. 2kV test pulse

The rationale for the 2kV test pulse is pretty clear in the standard. But I did not find any rationale for the common mode test.

Does anyone know if the older editions of the 60601-2-2 might have the explanation, or can someone tell me what the rationale might be?
 
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#2
Hello,

I read the rationale in 60601-2-2 again, and it does state:

"The common mode test represents the situation that can occur with the use of a defibrillator in combination with HF SURGICAL ACCESSORIES and HF APPLIED PARTS."

I think might understand it but want to check:

When a defibrillation event occurs, is the thought that it is unlikely that the active electrode will be in contact with the patient? Therefore, the only patient connection during defibrillation is from the neutral electrode, and the defib paddles.

Is this the correct situation that would result in a test setup to be common mode only?
 

Peter Selvey

Staff member
Moderator
#3
For defib proof test there is differential mode (between applied parts) and common mode (all applied parts at the same time). The differential mode test is the toughest as this potentially stresses the functional electronics of the applied part, for example applying 5000V pulse between RA and LA in an ECG. You can imagine the ECG electronics are designed only for ±5V or ±3V operation, so you need a special network to limit and absorb the effects of a differential pulse that large.

In IEC 60601-2-2 the standard is saying that the active electrode won't be in contact with the patient during defibrillation, hence the differential mode test is N/A, leaving only the common mode test.

Interesting thought: what happens to the active electrode during defibrillation? If it changes from being applied part to "operator accessible" then it would normally fail the test, since it is not isolated from the neutral electrode. In other words, during defibrillation it could be a source of shock to operators. Might be best not to open that can of worms ...
 
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