Richard, et al - Patty Elliot took care of Euro requirements.
I refer you to DHHS Laser Notice No. 42, dated 18DEC89. The FDA does not require labeling or reporting of a product that incorporates a Class I laser product that is "certified and reported by other manufacturers" into another product, under specific conditions: Don't monkey with the CDROM, just install it The CDROM is properly labeled and no labeling is removed from it The labeling of the CDROM meets the FDA requirements "in any service configuration" "The laser safety information provided by the certifying manufacturer is distributed with the final product." Peter L. Tarver Nortel [email protected] >---------- >From: [email protected][SMTP:[email protected]] >Sent: Wednesday, July 23, 1997 8:43 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] >
