Hello everyone,
I am designing a medical device with BF-type applied part (surgical power tool with micromotor).
The applied part is so small that I cannot implement more than 1 MOPP (working voltage of 48V) inside its metallic body (barrier C in attached picture).
The power supply is medical grade with BF class insulation. It provides 2 MOPP (4000VAC) from input to output (barrier A) and 1 MOPP (1500VAC) from output to ground (barrier D).
The applied part is driven by a 48V floating circuit with creepage distances between GND and protective earth for 1 MOPP at main voltage (barrier E).
To me, the design above respects clause 8.5.1.1 on the applied part for 2 MOPP at 48V with C + E.
The clause 8.5.2.1 for 1 MOPP at mains voltage is also respected with E.
But an expert asked for 2 MOPP at 48V between the applied part metal body and the secondary voltage (barrier B).
Wouldn't be C + E or C + D sufficient ?
P.S. : Patient leakage current limits are respected in Normal Condition and Single Fault Condition (even with SFC = shorted barrier C).
I am designing a medical device with BF-type applied part (surgical power tool with micromotor).
The applied part is so small that I cannot implement more than 1 MOPP (working voltage of 48V) inside its metallic body (barrier C in attached picture).
The power supply is medical grade with BF class insulation. It provides 2 MOPP (4000VAC) from input to output (barrier A) and 1 MOPP (1500VAC) from output to ground (barrier D).
The applied part is driven by a 48V floating circuit with creepage distances between GND and protective earth for 1 MOPP at main voltage (barrier E).
To me, the design above respects clause 8.5.1.1 on the applied part for 2 MOPP at 48V with C + E.
The clause 8.5.2.1 for 1 MOPP at mains voltage is also respected with E.
But an expert asked for 2 MOPP at 48V between the applied part metal body and the secondary voltage (barrier B).
Wouldn't be C + E or C + D sufficient ?
P.S. : Patient leakage current limits are respected in Normal Condition and Single Fault Condition (even with SFC = shorted barrier C).