Hi everyone,
I'm very glad to be a member of this forum. I've already read a lot topics, but I'm still confused about some safety related issues. It is the first time I design ME device and first standard I have in my hands
I'm designing hand-held, Internally Powered device (3.7V Li-Po). The whole device is going to be used in home so it has to comply IEC 60601-1-11. Patient will hold and operate it with one hand, in the other he will have smartphone (BLE communication). The only applied part (and also only accessible) of ME device is an enclosure made of solid, insulating material. For charging, I want to use USB socket (only power, not insulated from secondary), which is located in the back of the device and during its INTENDED USE, the patient doesn't touch it, as well as enclosure around the USB. Furthermore the USB socket is not accessible part, its a bit hidden into the enclosure, something like in attached photo.
According to Subclause 3.8, if there applied part has no PATIENT CONNECTIONS, during tests insulated applied parts are covered with foil (Clause 8.7.4.7) and treated as PATIENT CONNECTION. Between enclosure and applied part (patient connection) there should be MOP.
a) Can somebody help me to understand, if I can divide the insulated enclosure on 2 parts: first as applied part and second (around USB) as enclosure (accessible part)? (Something like below)
b) If yes, how to define MOP between applied part and enclosure?
c) If no, should I treat whole encosure as applied part?
d) If whole enclosure is treated as applied part, should I use 2 MOPPs for USB socket as @5V, cr: 3.4 mm, cl: 1.6 mm or rather 1 MOOP for USB @250V, cr. 4mm, cl. 2.5mm (according to MAXIMUM MAINS VOLTAGE for internally powered devices, Clause 8.5.3)?
e) Could You tell me if i correctly understand the clearance/creepage distance in terms of USB to accessible parts? (Photo below)
Sorry that post is so long, but every time I think I figured it out, next obstacles occurs.
Thanks a lot for Your help.
I'm very glad to be a member of this forum. I've already read a lot topics, but I'm still confused about some safety related issues. It is the first time I design ME device and first standard I have in my hands
I'm designing hand-held, Internally Powered device (3.7V Li-Po). The whole device is going to be used in home so it has to comply IEC 60601-1-11. Patient will hold and operate it with one hand, in the other he will have smartphone (BLE communication). The only applied part (and also only accessible) of ME device is an enclosure made of solid, insulating material. For charging, I want to use USB socket (only power, not insulated from secondary), which is located in the back of the device and during its INTENDED USE, the patient doesn't touch it, as well as enclosure around the USB. Furthermore the USB socket is not accessible part, its a bit hidden into the enclosure, something like in attached photo.
According to Subclause 3.8, if there applied part has no PATIENT CONNECTIONS, during tests insulated applied parts are covered with foil (Clause 8.7.4.7) and treated as PATIENT CONNECTION. Between enclosure and applied part (patient connection) there should be MOP.
a) Can somebody help me to understand, if I can divide the insulated enclosure on 2 parts: first as applied part and second (around USB) as enclosure (accessible part)? (Something like below)
b) If yes, how to define MOP between applied part and enclosure?
c) If no, should I treat whole encosure as applied part?
d) If whole enclosure is treated as applied part, should I use 2 MOPPs for USB socket as @5V, cr: 3.4 mm, cl: 1.6 mm or rather 1 MOOP for USB @250V, cr. 4mm, cl. 2.5mm (according to MAXIMUM MAINS VOLTAGE for internally powered devices, Clause 8.5.3)?
e) Could You tell me if i correctly understand the clearance/creepage distance in terms of USB to accessible parts? (Photo below)
Sorry that post is so long, but every time I think I figured it out, next obstacles occurs.
Thanks a lot for Your help.