Josh, I agree with your message below. It may not have been clear in my first email.
The FDA's Laser Notice 50 allows the use of EN 60825-1 for the "technical" aspects of laser safety, such as: determination of the laser classification, how to label the device, what information to put in the manual... However, as you state below, the FDA/CDRH still demands that manufacturers meet the documentation, reporting and tracking requirements (units tracked by serial number, model number, reports to the CDRH...) listed in CFR 21, Part 1040. Chris > -----Original Message----- > From: Joshua Wiseman [SMTP:[email protected]] > Sent: Wednesday, June 19, 2002 6:27 PM > To: Chris Maxwell; John Juhasz; Davis, Mike; Emc-Pstc (E-mail) > Subject: RE: Two Questions concerning the subject of Laser Safety > > Chris, > > As I recall Laser Notice 50 does not exempt you from the record keeping and > report of the CFR 21, only the qualification aspects. > > Regards, > Josh > > > ------------------------------------------- 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] 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"
