Hi All,
We have a medical device which is body worn for >30d. It is essentially a electrical brain stimulator. It have a plastic enclosure and two patient leads which will be implanted into patient during clinical use. The device will generate a (0-11.5mA/1.1Hz ) current to sitmulate patients brain. Intern circuit comprise 3.3V li-on battery, control IC and drivering circuit, and no SIP/SOP. Applied parts classified as TYPE BF.
For the electrical shock, we considered the whole device (patient lead/electrode and enclosure) as applied parts. my question is:
Thanks
We have a medical device which is body worn for >30d. It is essentially a electrical brain stimulator. It have a plastic enclosure and two patient leads which will be implanted into patient during clinical use. The device will generate a (0-11.5mA/1.1Hz ) current to sitmulate patients brain. Intern circuit comprise 3.3V li-on battery, control IC and drivering circuit, and no SIP/SOP. Applied parts classified as TYPE BF.
For the electrical shock, we considered the whole device (patient lead/electrode and enclosure) as applied parts. my question is:
1) is 2MOPP necessary between internal circuit and plastic enclosure? based on working voltage 3.3Vdc
2) because the device is body worn, I don't think we need 1MOPP based on 240V mains between internal circuit and enclosure, then the patient leakage current measurement is not necessary also.
3) how about the Patient auxiliary current? because cl. 8.4.2 a) requires that the "current" shall not exceed limits in table 3 and table 4. And in cl. 8.5.1.1 requires that" ME shall have 2 MOPs to prevent applied parts and accessible parts from exceeding the limits in 8.4.
This means that we shall have 2 mopps to limit the Patient auxiliary current. If we use resistors, then is the cr/cl and electric strength test applicable to this resistor, as specified in ANNEX of CL.4.8?Thanks