From: sleeper75se (sleeper75se_at_yahoo.se)
Date: 2002-03-03 04:23:35
Hi Steve,
sorry for the delay... there's been a lot of traffic here lately.
--- In buildcheapeeg_at_yahoogroups.com, "Suttons_Bay" <suttons_bay_at_yahoo.com> wrote:
> OK, so here's the skinny. I'm going to have to look up the
> requirements for an external medical device,
Ok, great!
The relevant safety spec. besides ICE60601-1 is IEC60101-2-26 (EEG
devices).
> The FDA has a great site for device submission:
>
> http://www.fda.gov/cdrh/devadvice/
I browsed the FDA site and took some notes. It looks like we can
forget FDA approval although it is free. There's a lot of paperwork
involved, and I think most people here are uninterested in doing
it. :) We don't have the organization for it either.
> Have you seen the typical devices out there? Some of the ones
listed
> from other members of the group are >$700. The cheap production of
> medical devices is available to those who can purchase in mass.
... and those who are non-profit. :) Ok, it is unlikely we can go
below $200, counting every little part, a case, electrodes and
batteries and so on, but it is still a lot less than the competition.
> Unfortunately, I don't know of any cheap InstAmps. I've worked
with
> the INA111. Sadly enough (welcome to corporate America) I threw 40
> of them in the trash about 3 months ago.
Ouch! Next time you're about to throw out some expensive parts,
consider donating them to a worthy cause. ;o)
Anyway, the inamps are not that terribly expensive, as we're only
aiming for 2-4 channels or so, not 250. Personally I think $30-$40
per channel (inamp + anti-aliasing filter) is an ok price.
> Another corporate example,
> I routinely purchase $100+ parts from Burr-Brown... that's more
than
> the device we're trying to aim for here!
Isolation amplifiers I gather? A nice solution, out of our reach...
> Europe, on the other hand, has TUV. TUV is a paid service, (our
last
> approval was >$7000. The benefit here is that they are a
consulting
> service... They won't approve you unless you pass.. but they'll
> advise you about what to do... and let you rework you design and
come
> back. Costly, but I like this method, policy, better.
>
I checked the FDA... they recommend a list of labs where one should
do the testing (TUV and Underwriters etc.) so I suppose it would cost
a big pile of money wichever way we turn.
> With TUV, you'll have more issues to cover... like, how much EMI
does
> your device radiate!
Thankfully we don't have to worry much about that. EMI coming from
other sources on the other hand ...
> > PS. If you have a good EEG/EMG/ECG design that you can share,
feel
> > free to do so! ;o) DS.
>
> I'm just getting into this (and the full time job (and fiancee)
takes
> time)... but I'll help where I can!
No problem, everyone contributes as much (or little) as he (where are
the she's?) wants!
Regards,
Andreas
This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:39 BST