Single Fault Condition for Internally Powered Medical Device

R

rickbert

#1
I'm trying to figure out which tests need to be done for leakage current for two battery powered deviced. One has a rechargable battery that is powered by an off the shelf DC adapter (60601 certified). The second uses a standard 9V battery. Both have electrodes that are applied parts. The test lab says that the worst case single fault condition is Mains voltage on a SIP/SOP. I see that for a the rechargable battery, but why do I need to apply 110V to an electrode plug for the 9V battery device? I need to put these justifications into the protocol, so I want to get them right and make them sound clean ("because the test house says so" isn't going to cut it).

Thanks for the help.
 
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P

PaulGr

#3
The test lab says that the worst case single fault condition is Mains voltage on a SIP/SOP
I think the testlab is right. If your device has a SIP/SOP, than it can be connected to other electrical equipment which might be defective leading to mains voltage on the SIP/SOP. I would think the leakage current measurements are then relevant for both adapter and internally powered models?

From your post it looks like your SIP/SOP is some 'electrode plug' could you clarify a little what this is? Perhaps it is not a SIP/SOP part at all.

Paul
 
R

rickbert

#4
Looking at it more, I see what you mean. The SIP/SOP works for the rechargeble device. The second device has no Sip/Sop. It has a connection for electrode wires, but that's it. I was considering this connection a SOP, but I think that is incorrect. This device is a simple box with a 9V battery, a couple knobs, a port for electrodes, cables, and disposable electrodes. I guess I could apply mains voltage to the electrodes, but the whole device is floating so I don't see what that would do. Thanks for the help!
 
P

PaulGr

#5
You are welcome. For further reading, there are some good topics in the cove related to IEC60601-1 and internally powered equipment, like this topic. (read the comments of Peter Selvey on testlabs with limited experience on battery powered devices)
 
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