IEC60601 Battery powered devices intended for measuring bio-impedance

X

xavo89

#1
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!
 
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E

esalsan

#3
Hi,

I have no electrical background and my experience with 60601 was only brief but, as I recall it you can summarise what you are trying to do, your risk analysis and the design decisions you are taking based on that risk analysis and how you are planning to test it, and contact your testing house for advice - a sort of "is this the right approach?" question.

Sometimes they can also tell you that some of the parts that are technically not applied parts will be tested as such.

Good luck!
 

Peter Selvey

Staff member
Super Moderator
#4
There are roughly 1250 discrete requirements in IEC 60601-1. Most would be not applicable for a battery operated device, with the main remaining ones being related to marking, manuals, mechanical tests (e.g. drop tests), battery related items and patient auxiliary currents (normal and single fault condition).

But you still need to go through each of the 1250 items to figure out what is applicable. For example, there is a requirement for connectors hidden somewhere in there, which might be important if you use detachable cables for connecting to the electrodes.

The standard has a limit of 100uAac for patient aux current, compensated for frequencies above 1kHz. If for example your current is 375uArms at 10kHz, the compensated value would be 37.5uA (assuming a 10kHz sine wave), which would be well below the limit. You should consider also fault condition, e.g. failure of capacitor or other part which could increase the current. A simple design approach might be to break the output capacitor into two so that failure of one cannot exceed ac or dc limits.
 
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