Do OpenBCI products have "international approval"?
Many of the affordable ECG, EEG, MEG, etc. devices are devices which are advised by their manufacturer only to be used with batteries, to prevent electrical shock. Are the OpenBCI products safe to used with humans, and do they have an international approval that the OpenBCI products are safe to be used with humans?
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There have been MANY previous threads on this subject, please use the "Google Advanced Search" button in upper right column, before posting new threads.
https://www.google.com/search?as_q=medical+certification&as_sitesearch=openbci.com
https://docs.openbci.com/docs/08FAQ/Liability
William
Here is a list of published papers utilizing OpenBCI, 142 at last count,
https://docs.google.com/spreadsheets/d/1WvolD2-QJ5aUJy5o0Dq5wdFQtLMkMtppZT8s_ihYyA4/
And comparison of Cyton with medical grade g.tec device,
https://arxiv.org/pdf/1606.02438.pdf
That info is on our FAQ page,
https://docs.openbci.com/docs/08FAQ/FAQLanding
Thank you, William. The disclaimer of OpenBCI is long. So I ask once more a simple question. OpenBCI boards are powered by batteries. Is it true that battery powered devices like the OpenBCI boards don t need a security test for electric shock?
There is no "security test for electric shock", other than those done during the tens-of-thousands dollars medical certification processes that were linked above. Did you read the links? The ADS1299 EEG analog to digital converter chip used in Cyton, is already used in many other commercial EEG devices, some of those with medical certification. The highest voltage present in OpenBCI boards, is that of the battery power supply. These voltages are not capable of "electric shock".
Similar statements can be made for the instrumentation amplifier chips and analog to digital converters used on Ganglion.
The Liability section should take only a minute or so to read. If you do not understand something in the statement, please ask for clarification.
https://docs.openbci.com/docs/08FAQ/Liability
I took this minute, and read it trough. Things are beginning to become a little bit more clear to me in the field of certification process. There is a big variety in the quality of these certifications. For some it is a certification when the accuracy measurement is done by a Dr. PhD., for others when a device is compared to a medical grade device and the study is published on rresearchgate.net. To avoid the tens-of-thousands dollars medical certification processes, one can also make a prospective study with a group of students and publish the results in Cardiovascular Diagnosis and Therapy, as the group of Milind Y. Desai did it with commercially available heart rate monitors:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6732081/
I suppose a prospective study could also be done by a group of people using OpenBCI to avoid the tens-of-thousands dollars medical certification processes.
OpenBCI devices are NOT medical devices as stated in the Liability link. Therefore they do not need medical certification.
https://docs.openbci.com/docs/08FAQ/Liability
The previous links showed comparison of Cyton with the g.tec medical certified amplifier, with excellent results. Other links showed the 142 published research papers utilizing OpenBCI.
If you had read through some of these previous threads (link posted above):
https://www.google.com/search?as_q=medical+certification&as_sitesearch=openbci.com
You can see that official medical device certification is called IEC 60601 standard compliance. One of the threads above mentioned:
This statement is incorrect. There is only ONE medical devices certification process, IEC 60601, and it's derivatives.
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 are comparable to the tests of Milind Y. Desais group would be very helpful, and I would be very happy with such tests.
The Arxiv paper by Jeremy Frey (previously quoted above), is such an 'accuracy' test. Did you read it?
That's a very important cetificate for clinical research after Institutional Review Board have approved,I'm a doctor ,and I want to use low cost and effective OpenBCI in rehabilitation for stroke suvivors in hospital ,but the first step (IRB approve)seems difficult.
@sonic, hi. Many other research groups have passed their local IRB requirements without specifying that OpenBCI boards must have "medical device certification". Please see the list of publications / citations,
https://docs.google.com/spreadsheets/d/1WvolD2-QJ5aUJy5o0Dq5wdFQtLMkMtppZT8s_ihYyA4/
In fact, some of the IRB approvals were done by closely examining the paper by Jeremy Frey, which compares Cyton with the g.tec medically certified similar EEG device. OpenBCI is not a medical device, but has been used in many research contexts. As the citation list clearly shows.
Comparison of Cyton with medical grade g.tec device,
https://arxiv.org/pdf/1606.02438.pdf
Please read our Liability page,
https://docs.openbci.com/docs/08FAQ/Liability
This current thread on the forum is long and frankly, confusing. OpenBCI has NEVER had any 'safety' issues or problems in the thousands of units in the field. The battery powered nature of the boards, precludes any possible 'electric shock' phenomena.
Regards, William