Mike - See below.
Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services San Jose, CA peter.tar...@sanmina-sci.com > -----Original Message----- > From: Davis, Mike > Sent: Wednesday, June 19, 2002 6:59 AM > > 1. Are manufacturers required by the FDA to record serial numbers of Laser modules. Where is this requirement located? Does this apply to photodiodes also? A) Not in so few words. The requirements imply the need for a tracking method by way of a QC program, but nothing is specifically identified. Also, if there's a field incident, traceability to a manufacturing lot would likely become an issue, especially if the field incident is serious enough to warrant a recall (you would, no doubt, prefer to recall only some modules from the field, rather than all of them). S/Ns are the most common method I've seen used for this. B) photodiodes are not controlled by the FDA; neither are noncoherent LED sources > 2. I have a concern of what I need to know about Laser safety but was afraid to ask (because it would cost more than my compliance budget ($0) would allow without manager approval). In other words (what is the second question?... I am getting there.) I am looking to hire a consultant or take a course. My supervisor wants me to create for him a proposal answering the type of questions that support the need to either attend a course or have a consultant educate me or our professionals here so that he can decide whether or not we need to hire a consultant, etc, etc. To keep this short, I will paraphrase by saying that the type of questions he would like to have answered is it worth the expense to getting smart, as engineers and a manufacturer of ITE, in the manufacturing of laser systems? I believe it's worth "getting smart." I recommend (you just missed the last one): International Laser Safety Conference March 10-13, 2003 Jacksonville, FL http://www.laserinstitute.org/conferences/ilsc2003/index2003 .htm > Here is my question... > Is there information available that summarizes the responsibilities to Laser Safety of Compliance, Design, Manufacturing, and Test Engineers that manufacture laser systems? Refer to 21CFR and the CDRH web site for all of this. You'll find copies of the initial and annual reports and links to 21CFR. Some of the information you want is in early sections of Section 1040 (1040.01, .02) so don't ignore them and only review 1040.10. http://www.fda.gov/cdrh/ ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
