Re: FDA EEG Devices Guidance for 510(k) Content

From: sleeper75se (sleeper75se_at_yahoo.se)
Date: 2001-12-20 21:11:04


--- In buildcheapeeg_at_yahoogroups.com, "yaniv_vi" <yaniv_vi_at_yahoo.com> wrote:
> so anmyway people , please raise ideas how to solve this issues .

Hello Yaniv,

one thought just occurred to me:

There are many electronics magazines on this planet. All of them have
schematics and sometimes, PCB layouts with each issue. These devices
have not passed any testing at all (how would they afford it?).
I'd bet most of them have published EEG/ECG/other biosignal-monitors
over the years. The most prominent is the HAL-4 published by Circuit
Cellar.

The point I'm getting at here, is that we can start doing this as a
kit: This group supplies the design, and possibly a factory-made PCB.
Maybe we can find a kit-reseller to handle the details for us.
Anyway, the liability and the risk ends up with the user, just as the
designs published in an electronics magazine.

Of course, we should make it as safe as possible, but we need not
worry about compliance with CE/FCC/FDA/IEC/<some-other-organization>
standards.

As for informal testing testing (e.g leakage current and isolation),
most we can do that for ourselves, though I'd leave the 5000V
isolation test and EMI-test to someone with the right gear.

What do you think?

/Andreas



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