muhammad sadiq
Starting to get Involved
I just started working on a APD dialysis machine as an internee, so I am new to reading through 60601-1 standard.
1) About our APD machine it gets its 24v dc supply, through an external medical grade power supply which is iec 60601-1 compliant(model) and have only two leads (no earth pin), it has been told to me by my seniors that our ME is a Class-II device and hence require double insulation or reinforced insulation, my question is what does this double insulation looks like in practical, my understanding is , if we give the relevant air clearance and creepage distance between electrical board(which works on 12V/5V) and enclosure and the enclosure is made of a non conductive material that gives us 2 MOPP, and hence our machine is class II compliant and have double insulation, so am I right and what if our machine have metal enclosure and we don't have a earth(Class II) how do you give that 2nd MOPP?
2) While going through this forum I came across an argument which said " the classes(class I, class II) are mentioned only for machines that are connected directly to the supply mains (220-240VAC), but if you have a adaptor(24VDC medical grade,60601-1 compliant) in between your ME and mains then these classes do not apply on you " is this correct assessment??
1) About our APD machine it gets its 24v dc supply, through an external medical grade power supply which is iec 60601-1 compliant(model) and have only two leads (no earth pin), it has been told to me by my seniors that our ME is a Class-II device and hence require double insulation or reinforced insulation, my question is what does this double insulation looks like in practical, my understanding is , if we give the relevant air clearance and creepage distance between electrical board(which works on 12V/5V) and enclosure and the enclosure is made of a non conductive material that gives us 2 MOPP, and hence our machine is class II compliant and have double insulation, so am I right and what if our machine have metal enclosure and we don't have a earth(Class II) how do you give that 2nd MOPP?
2) While going through this forum I came across an argument which said " the classes(class I, class II) are mentioned only for machines that are connected directly to the supply mains (220-240VAC), but if you have a adaptor(24VDC medical grade,60601-1 compliant) in between your ME and mains then these classes do not apply on you " is this correct assessment??