Hi, Mark. I'm not really certain what your asking. Do you want to know if you must file a laser safety report with the CDRH? If so, then yes.
If you're trying to understand which standard to use, 21CFR or IEC 60825-1, the answer is either, but there is some additional text required when you use the IEC standard. Can you clarify your question? Regards, Peter L. Tarver, PE ptar...@ieee.org > From: Mark Schmidt > Sent: Friday, May 02, 2008 7:24 AM > > Correction Should be IEC60825-1 not IEC60950 > ________________________________ > From: Mark Schmidt > Sent: Friday, May 02, 2008 10:17 AM > > Hi everyone, > > I having trouble understanding the requirements for use of a > Class IIIa laser (laser pointer) for alignment purposes into > a product line. Would I be required to file an annual report > to the CDRH. Now my research tells me that if I conform to > IEC60825-1 (self approving) or 1040.11 it would be compliant. > Does anyone have experience with this or can they please > direct me to the appropriate documents. I have searched the > CDRH site and every thing leads to I can use IEC60950 or > 1040.11and12 but nowhere (that I can see) does it tell me it > is required. I have emailed the contact at the FDA listed in > Laser Notice 53 unsuccessfully. Any help would be appreciated. > CONFIDENTIALITY This e-mail message and any attachments thereto, is intended only for use by the addressee(s) named herein and may contain legally privileged and/or confidential information. If you are not the intended recipient of this e-mail message, you are hereby notified that any dissemination, distribution or copying of this e-mail message, and any attachments thereto, is strictly prohibited. If you have received this e-mail message in error, please immediately notify the sender and permanently delete the original and any copies of this email and any prints thereof. ABSENT AN EXPRESS STATEMENT TO THE CONTRARY HEREINABOVE, THIS E-MAIL IS NOT INTENDED AS A SUBSTITUTE FOR A WRITING. Notwithstanding the Uniform Electronic Transactions Act or the applicability of any other law of similar substance and effect, absent an express statement to the contrary hereinabove, this e-mail message its contents, and any attachments hereto are not intended to represent an offer or acceptance to enter into a contract and are not otherwise intended to bind the sender, Sanmina-SCI Corporation (or any of its subsidiaries), or any other person or entity. - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.org Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
