The FDA Guide for Compliance, answers all your questions. There are
some exemptions to labelling requirements if you are using a class I
OEM unit inside your product. (like a PC, it doesn't repeat the
warnings on the outside).There are no special treatment for test
equipment.Don't assume it is class I unless it is clerly labelled so.
That much is mandatory by the FDA. Whether your product is a laser
product, that depends on certain tests performed on the final product.
such as ability to open a cover and get laser exposure using a mirror
etc.
Hans Mellberg
______________________________ Reply Separator _________________________________
Subject: CD ROM's
Author: Non-HP-richard.payne ([email protected]) at
HP-ColSprings,mimegw5
List-Post: [email protected]
Date: 7/23/97 9:59 AM
Good Day All:
I have a question. Perhaps this is not quite the right forum, but I am
hoping that if no one here has the answer that at least you may be able to
point me in the right direction.
In the U.S. there are FDA requirements for Laser products.
If I take a CD ROM drive that I have procured from a reputable manufacturer
and which that manufactrurer has properly registered with the FDA (and
which bears the appropriate markings) and I install this INTERNALLY into my
computer product, what are the reporting and labeling requirements for the
end product, my computer ?
Is my computer now a Laser product, or is the CD ROM drive the Laser
product ?
I am assuming here that the Laser in the CD ROM is Class I (I hope and
believe that this is typically the case).
If my end product is not a computer, but rather a piece of Test and
Measuring Equipment does that change anything ?
What about the rest of the world ? If I comply with IEC825/EN60825, are
there any other countries where there are additional reporting and labeling
(or other) requirements ?
Your comments will be very much appreciated.
Richard Payne
Tektronix, Inc.
[email protected]
