Testing EEG, PSG and EMG input amplifiers for lead leakage per IEC 60601-2-26

JamesKnightRenownCSE

I need to perform electrode lead leakage safety testing on EEGs, Electromyographs, and Polysomnographs. Does anyone use a tester for this or have you built one? I need to perform IEC 60601-2-26 Ed. 2.0 en:2002 Medical Electrical Equipment - Part 2-26: Particular Requirements For The Safety Of Electroencephalographs This doc pecifies the particular safety requirements for electroencephalographs, i.e. devices to produce an electroencephalogram. This Particular Standard amends and supplements IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety as amended by its Amendment 1 (1991) and Amendment 2 (1995).

wjcroft

Hi James,

OpenBCI devices are not IEC 60601 (medically) certified. Because of the huge costs involved and limited market. Have you considered contacting other manufacturers who ARE certified? As you may know there are also specialty certification companies that shepherd manufacturers through the process.

https://www.google.com/search?q=iec+60601-1+certification

For example:

https://keystonecompliance.com/iec-60601-1/
https://f2labs.com/medical-devices-directive-testing
https://mpe-inc.com/iec-60601-medical-device-safety-standard/
Etc.

https://docs.openbci.com/FAQ/Liability/
[Disclaimer of medical, clinical, or diagnostic use]

William

Billh

James,
Good idea. I think that somebody should definitely do this. Trouble is, just getting an official copy of the required documents costs real money. It's a nice racket I guess for the IEC, as far from open source as it gets .

If you are planning to test for leakage from mains, note that you should NOT be connecting ANYTHING from mains to your OpenBCI device. That is why batteries! When testing, therefore, I would check for leakage from the mains that are connected to an AC adapter of the laptop used for the OPENBCI software (which is connected, via Bluetooth, to the device) to the box or other setup holding the OpenBCI device. There should be NO leakage POSSIBLY measurable above random noise!

Note that the laptop you use should ITSELF be tested as safe for hospital use.