From: Joerg Hansmann (info_at_jhansmann.de)
Date: 2001-05-25 01:23:26
Hi,
----- Original Message -----
From: Waldemar Neto <wpneto_at_o...>
To: <buildcheapeeg_at_yahoogroups.com>
Sent: Friday, May 25, 2001 12:00 AM
Subject: [buildcheapeeg] Cont. Re: domain registration, Certification
> I wonder that it is necessary to mention for registering office
> all the purposes in which the subject (RS232 EEG) is been applied
> to
It is necessary to define a purpose and exclude others because
depending on that the device will be assigned to a class (class 1
requirements are easy to achieve, 2a and 2b are medium difficult
and class 3 is very difficult)
An EEG-device could serve the purpose to diagnose a neurological illness
or to diagnose brain death before a clearance for transplanting organs.
It should be clear that such an EEG-device must display correct values
under any circumstances. Therefore the whole system (includes the PC)
will be checked in a risk analysis.
I think the risk is much smaller in a biofeedback-device because (hopefully)
no one will ever consider to use it in the above mentioned scenarios.
> - and maybe the relation with a "non respectable field like biofeedback "
> can annoy the burocratic minds from FDA&similars.
>
BTW. I think the brainmaster has a FDA registration as a biofeedback
device and not as as an EEG-device.
> If it can give troubles for certification - we shall consider work underground
> - we surely owe that for Joerg .
>
> Let's go to the alchemist 's caves !
We should consider this only as a last resort. An official certification
as a medical device (or whatever) would be much better.
Regards,
Joerg
This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:30 BST