IRB (Institutional Review Board) requirements for IEC60601 certification

Icarus77Icarus77 Israel
edited November 2018 in Research
Hi all,

Since OpenBCI is not FDA / CE certified, My IRB committee requires "at least" an IEC60601 certification.
My attempts to wave this by stating it is wireless (BTE / WIFI) and the only thing in contact with the subject's scalp is 4 well isolated AA 1.5V batteries were not fruitful. 
They ask for proof / documentation to allow me to do research with this device. Proof the electrodes are indeed passive and not active and proof the device is electromagnetic safe.

Any idea? How did you bypass these? Do you have anything written that may satisfy the IRB team?

Thanks, 
Sergiu

Comments

  • wjcroftwjcroft Mount Shasta, CA
    Sergiu, hi.

    OpenBCI does not have 60601 certification currently because it is an extremely expensive process requiring fees of thousands to possibly tens of thousands of dollars.


    Other companies such as g.tec do offer EEG equipment in two classes: 60601 certified, and NOT certified. The certified equipment is much more expensive so that they recover their costs.

    On the other hand, see this research report comparing OpenBCI Cyton to a g.tec medical grade device,


    We came out with excellent results.

    Regards,

    William

  • Icarus77Icarus77 Israel
    Hi, 

    Thank you for the replay. I understand the reasons why there is no certificate. I know this research and cite it in my proposal to the IRB committee.
    However I didn't see reference to the IRB process they had gone through. I wrote an email to the author Jeremy Frey, hope to get a replay.
    Anyhow, I am not familiar with the procedures in USA, but in Israel, if you sell something, you usually need a license to sell it based on that it's a relatively harmless device (which I know it is, but the IRB ppl give me hard time).

    I will explore other paths. Maybe the reason for the hard procedure is because its a hospital and the subjects are patients or outpatients..

    Thank you again. Hope to find a way to use these fine boars and firmware.
    Regards,
    Sergiu
  • wjcroftwjcroft Mount Shasta, CA
    Many consumer grade biosensing devices have no 60601 approvals: Muse, Emotiv, Spire, HeartMath, etc.

  • wjcroftwjcroft Mount Shasta, CA
    Dozens of such consumer biosensing application devices at this annual conference. 


  • Icarus77Icarus77 Israel
    Thanks, I know. ill try to show this to the IRB committee.
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