[Eeglablist] active electrodes

[Makoto Miyakoshi]

Dear Geoff and Jeff,

Thank you for your expert knowledge and quick responses!

> Any device which has US safety certifications and FCC Part 15
certification can be used safely on human subjects.
> Many EEG systems are sold in the USA with FDA clearance for clinical use

This is very good to know. Maybe my knowledge was based on very old
information.

Makoto

On Thu, Mar 26, 2015 at 11:09 AM, Eriksen, Jeffrey :LGS Neurodiagnostics <
JEriksen at lhs.org> wrote:

>  Any and all:
>
>
>
> FDA clears devices for general safety and efficacy for clinical use in the
> USA but does not care about research use. UL/CSA/ETC etc. certifies
> electrical safety specifically. You are covered legally for research use by
> your institutions IRB process, which should address the electrical safety
> issue and not care about FDA or clinical use.
>
>
>
> In Europe I believe the CE regulates devices for general safety and
> efficacy, as well as electrical safety specifically, combining the roles of
> FDA and UL.
>
>
>
> Many EEG systems are sold in the USA with FDA clearance for clinical use
> and that have up to 256 channels with electrode caps or nets that use
> variants of the 10-20, 10-10, or 10-5 system, or uniform geodesic spacing
> as the EGI produces. Some of these have active electrodes. Now it may be
> the case that the FDA does not clear any active electrode system for
> clinical use in the USA, but that has no impact on using them for research,
> as your IRB should take care of assuring their electrical safety.
>
>
>
> -Jeff Eriksen
>
> Portland, OR
>
>
>
> *From:* eeglablist-bounces at sccn.ucsd.edu [mailto:
> eeglablist-bounces at sccn.ucsd.edu] *On Behalf Of *Makoto Miyakoshi
> *Sent:* Thursday, March 26, 2015 10:31 AM
> *To:* Friedman Doron
> *Cc:* eeglablist at sccn.ucsd.edu
> *Subject:* Re: [Eeglablist] active electrodes
>
>
>
> Dear Doron,
>
>
>
> Interesting topic. I heard a rumor that the FDA-approved EEG recorder in
> US (I don't know which) supports only the classical 10-20 system
> channels... I could be wrong though. Anyone on the list please tell us what
> you know about this. I'm curious to know too. Thank you.
>
>
>
> Makoto
>
>
>
> On Mon, Mar 23, 2015 at 2:10 PM, Friedman Doron <doronf at idc.ac.il> wrote:
>
> Hi,
>
>
>
> This is not directly related to EEGLAB but perhaps of interest to many of
> us: my understanding is that none of the devices with  active electrodes
> have any standard approval, such as CE (Europe) or FDA (US). Does that mean
> all of us who are using them in research labs are not covered legally? And
> what about commercial applications, such as neurofeedback?
>
>
>
> Thx
>
>
>
> -          d
>
>
>
> Dr. Doron Friedman
>
> Senior Lecturer
>
> Sammy Ofer School of Communications
>
> Office phone number: +972-9-9527654
>
> Room C225, Sammy Ofer building
>
> The Interdisciplinary Center, Herzliya
>
> PO Box 167, 46150
>
>
>
> Director, Advanced Reality Lab
>
> http://avl.idc.ac.il
> <https://urldefense.proofpoint.com/v2/url?u=http-3A__avl.idc.ac.il&d=AwMFaQ&c=5aMxbibQyX6B-W2mpD2HYH5lwK3h7A1hIsNQieXCZKA&r=RW9gWwlQ_echeF9GoAB-bw&m=6L-dSIt9h2vweNlBzFyy6iquomgFXIF83rBhD7AQxz4&s=ToDqVhPrmroKCdS7-IP_lg46ljd4qjfvUrYM1vkgIAo&e=>
>
>
>
>
> _______________________________________________
> Eeglablist page: http://sccn.ucsd.edu/eeglab/eeglabmail.html
> <https://urldefense.proofpoint.com/v2/url?u=http-3A__sccn.ucsd.edu_eeglab_eeglabmail.html&d=AwMFaQ&c=5aMxbibQyX6B-W2mpD2HYH5lwK3h7A1hIsNQieXCZKA&r=RW9gWwlQ_echeF9GoAB-bw&m=6L-dSIt9h2vweNlBzFyy6iquomgFXIF83rBhD7AQxz4&s=xgb-kWcP1eg4RfH_w3dfO2FBNObD9O2WRS4uRSOkPkw&e=>
> To unsubscribe, send an empty email to
> eeglablist-unsubscribe at sccn.ucsd.edu
> For digest mode, send an email with the subject "set digest mime" to
> eeglablist-request at sccn.ucsd.edu
>
>
>
>
>
> --
>
> Makoto Miyakoshi
> Swartz Center for Computational Neuroscience
> Institute for Neural Computation, University of California San Diego
>



-- 
Makoto Miyakoshi
Swartz Center for Computational Neuroscience
Institute for Neural Computation, University of California San Diego
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://sccn.ucsd.edu/pipermail/eeglablist/attachments/20150326/b198bb10/attachment.html>