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Hi everyone!
We are currently designing an impedance measurement device which will also be intended for measuring bio-impedance, that is, for body measurements. Therefore, we want to know how to ensure our device is compliant with IEC60601. We have read the IEC60601-1 but we are not experts on it, so some doubts came up.
The device requires up to 4 patient connections (applied parts): two for current injection through the body and the other two for potential measuring. Current injection is limited to 375 uARMS @ 10-100 kHz. Besides, all 4 connections are ac-coupled with capacitors, so no risk of dc currents is present. This capacitors should also reduce currents of 50 Hz to a safe value. The equipment will be battery-powered (single cell rechargeable ion-Li battery) but battery charge will never be performed whenever the device is connected to the patient.
The problem is: which electrical tests should our device pass? Since it is battery powered neither earth leakage nor patient leakage current would apply, right? From this point of view, only patient auxiliary current should be tested. Any idea of what other electrical tests should our device pass?
Thank you very much!
We are currently designing an impedance measurement device which will also be intended for measuring bio-impedance, that is, for body measurements. Therefore, we want to know how to ensure our device is compliant with IEC60601. We have read the IEC60601-1 but we are not experts on it, so some doubts came up.
The device requires up to 4 patient connections (applied parts): two for current injection through the body and the other two for potential measuring. Current injection is limited to 375 uARMS @ 10-100 kHz. Besides, all 4 connections are ac-coupled with capacitors, so no risk of dc currents is present. This capacitors should also reduce currents of 50 Hz to a safe value. The equipment will be battery-powered (single cell rechargeable ion-Li battery) but battery charge will never be performed whenever the device is connected to the patient.
The problem is: which electrical tests should our device pass? Since it is battery powered neither earth leakage nor patient leakage current would apply, right? From this point of view, only patient auxiliary current should be tested. Any idea of what other electrical tests should our device pass?
Thank you very much!