From: yaniv_vi (yaniv_vi_at_yahoo.com)
Date: 2001-12-20 10:08:01
hey doug
i don't understand one thing , ,if the brainmaster haven't passed fda
tests until 1999 , what kind of tests he had passed ? did he passed
any tests before that ?
did he have any claims before that about safety ?
if i look at the premarket notitfication as a guideline (
1 . maybe we don't want to pass it
2 . still it guides on the dangers in such equipment and one way
of responsibly preventing them ) , still we would need to go to
labs to test the following (or to restrict the device in some
places - which maybe a good option ? ) :
EMI
Leakage current -
so the matter is : how can we decrease this costs as much as we can ?
and where from we get the money needed for them ?
one way to prevent the need of leakage current testing is (? )
: use infra red/fiber comm , use a box that we can prove isolation
for .
other thing to do is to find a lab that would maybe do this testing
on volunteer basis ,or maybe on some money from the sales of the
device would go to that lab ?
but again ,what if we need testing for each manufactured device ?
i'm not sure it's needed but , again i don't have any experiene in
liability issues .
so anmyway people , please raise ideas how to solve this issues .
sincerly
yaniv vilnai
--- In buildcheapeeg_at_yahoogroups.com, Doug Sutherland <wearable_at_earthlink.net> wrote:
> C. Safe Electrical Design Criteria
>
> 1. Leakage Current. Specify measured patient to ground and
> chassis to ground leakage current of the device. How does
> it compare with industry standards (e.g., IEC 601-1, or
> UL 2601)? (See Ref. 4)
>
> 2. Safety Standard. Indicate the extent to which the device
> conforms to any industry standard (i.e, UL 2601 or any
> other electrical safety standard).
>
> 3. Isolation. The manufacturer should specify the means by
> which isolation from commercial power and power line
> ground (return) is achieved. This may be achieved by:
>
> a. labeling that claims that the device meets UL 2601,
> or some other appropriate industry standard.
>
> b. employing battery operation. (Provide assurance that
> device cannot be operated with a line-powered battery
> charger.)
>
> c. the use of an isolation transformer, or equivalent
> techniques, that provide fault protection by redundant
> insulation. (UL 2601 specifies several acceptable
> transformer designs for patient isolation).
>
> http://www.fda.gov/cdrh/ode/eedev.html
This archive was generated by hypermail 2.1.4 : 2002-07-27 12:28:35 BST