For safety reasons, any EEG system should be either battery powered, or comply with IEC 60601 medical standards. Neither of these board comply with 60601. Nor does OpenBCI, but those boards ARE batter

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 th

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.

Thank you William. OpenBCI devices are not medical devices, and there is only one medical devices certification process, IEC 60601. But for me personally, accuray tests for the OpenBCI boards which a

This statement is incorrect. There is only ONE medical devices certification process, IEC 60601, and it's derivatives.

You can see that official medical device certification is called IEC 60601 standard compliance. One of the threads above mentioned:

rare and low probability. But relevant in IEC 60601 medical applications.) Does the NODEMCU allow direct connection of a lithium battery, say with a connector not visible on the back?

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

"From a design point of view" there are MANY fail safe features required in IEC 60601 devices. Such that if particular components short out or fail, the system is guaranteed to be safe to th

https://www.google.com/search?as_q=60601&as_sitesearch=openbci.com

What more would it take to get the Cyton to be 60601 compliant. I see that there is an EEG standard 60601-2-26, I don't know what other standards would be applicable.

possible isolation, and (although not CE or IEC 60601 rated), would give excellent isolation from mains voltages. If your SOC mainboard allows a usb dongle connection, this is easy.

http://openbci.com/forum/index.php?p=/search&Search=60601

Many consumer grade biosensing devices have no 60601 approvals: Muse, Emotiv, Spire, HeartMath, etc.

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.

are some models now that meet medical 5KV ISO 60601 standards, although 3KV is quite decent and what Adafruit offers.

If you are insistent on powering from USB, you may want to consider what is called a USB isolator. These are available in various gradations, including medical rated ones. These devices galvanically i

There are some related discussions below on the cost of 60601 certification for consumer level headsets and biosignal devices.

The Adafruit USB isolator is going to be fine for your application. The Analog Devices iCoupler (monolithic air core transformer) parts inside it are rated for Medical grade (IEC 60601, 5000V) isolati

The Adafruit isolator (built on the AD parts) provides medical grade isolation on the data lines, and fairly robust isolation on the DC/DC converter. If battery power is used, then you have basically