muhammad sadiq
Starting to get Involved
HELLO,
I am working on a APD dialysis ME , which is powered by 2 prong class II medical grade power supply that provides 24 volts at the output end but no earth
so I was going through all the leakage testing that the 60601-1 tells us to do , touch leakage , patient leakage etc
but since 60601-1-11 states that the CLASS II device for potable home use medical device cannot have a protective earth and functional earth in the system, my question is how these leakage test are performed in practical in the absence for earth?
The confusion is that it seems like leakage test are mostly taken with respect to ground eg for patient leakages its current passing through applied part to the earth, but since we don't have a PE or FE, how do I check practically this leakage current
1) DO I provide earth from some other means. (our medical grade power supply is only 2 probe and is class 2 so no earth) OR
2) I make the connection from applied part to the neutral of the mains ??
3) i make the connection from applied part to -ve of DC supply?
a figure is attached for visuals
I am working on a APD dialysis ME , which is powered by 2 prong class II medical grade power supply that provides 24 volts at the output end but no earth
so I was going through all the leakage testing that the 60601-1 tells us to do , touch leakage , patient leakage etc
but since 60601-1-11 states that the CLASS II device for potable home use medical device cannot have a protective earth and functional earth in the system, my question is how these leakage test are performed in practical in the absence for earth?
The confusion is that it seems like leakage test are mostly taken with respect to ground eg for patient leakages its current passing through applied part to the earth, but since we don't have a PE or FE, how do I check practically this leakage current
1) DO I provide earth from some other means. (our medical grade power supply is only 2 probe and is class 2 so no earth) OR
2) I make the connection from applied part to the neutral of the mains ??
3) i make the connection from applied part to -ve of DC supply?
a figure is attached for visuals