EEG device certifications to use for research

Matt16 · October 2016

Hello,

I am planning to purchase OpenBCI for research at the undergraduate level. My IRB is requiring that I tell them specifically what safety certifications the device has, as well as provide proof that after purchasing I am legally allowed to use the device for research purchases.

Thank you,
Matt

biomurph · October 2016

Hi Matt,

The short answer is that we don't have certifications for the device. Please review the disclaimer at the bottom of the product page for more specific information.

Matt16 · October 2016

Thank you biomurph. I hope they will understand and be ok with this.

wjcroft · October 2016

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

http://openbci.com/forum/index.php?p=/discussion/677/biomedical-regulation-and-security

http://openbci.com/forum/index.php?p=/discussion/511/openbci-for-medical-research-in-neurointensive-care-eeg

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

In short, IEC certification costs tens of thousands of dollars. Which is easy for a medical device company charging $10K+ per sale. But less possible for open source hardware projects.

Also see,

https://arxiv.org/pdf/1606.02438.pdf

Matt16 · October 2016

Thanks wjcroft!

That article will be great to include in my literature review.

Haseeb · November 2018

[Original thread title: Standards and benchmarks followed in designing Cyton board]

What are the international standards you followed while designing Cyton board?

wjcroft · November 2018

@Haseeb, hi.

I merged your newly created thread into this existing thread. See some of the previous posts and links. Such as,

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

Regards,

William

EEG device certifications to use for research

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