Ron, UL cannot trust the data submitted to the FDA by the manufacturer since their Mark is placed on the product and they have to take responsibility. UL must ensure that data submitted was performed under laboratory conditions with calibrated equipment, etc. In many cases and depending on the laser component and construction, UL wants to perform their own laser safety evaluation and /or tests. PETER S. MERGUERIAN Go Global Compliance Inc. pe...@goglobalcompliance.com http://globalcompliance.blogspot.com Tel: (925) 487-4640
________________________________ From: Ronald R. Wellman <rwell...@wellman.com> To: Charlie Blackham <char...@sulisconsultants.com>; EMC-PSTC <emc-p...@ieee.org> Sent: Fri, April 2, 2010 5:03:29 AM Subject: RE: UL60950-1 requirements for lasers - thanks all Hello Charlie, I am curious as to why UL insists on a full FDA/CDRH Laser Product Report when that report is really for FDA. Instead, UL should be willing to accept a copy of the Accession letter your receive from FDA for the report. I know of two UL competitors that accept the Accession letter for NRTL certification, at least for ANSI/UL 61010-1. Best regards, Ron Wellman From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Charlie Blackham Sent: Thursday, April 01, 2010 11:34 AM To: 'EMC-PSTC' Subject: RE: UL60950-1 requirements for lasers - thanks all Thanks all for the responses. Now have a plan to go back to UL Other NRTLs are not an option due to end customer requirements Regards Charlie From: Charlie Blackham [mailto:char...@sulisconsultants.com] Sent: 01 April 2010 16:07 To: 'EMC-PSTC' Subject: UL60950-1 requirements for lasers Group Have a piece of UL60950-1 telecoms equipment containing a laser: The laser has 3rd party report to IEC60825 Given the accepted similarities between 21CFR1040 and IEC60825 as detailed in FDA Laser Notice 50 - has anyone successfully used “an IEC60825 report and laser Notice no.50” to meet this requirement for UL? (UL are currently insisting on a full CDRH report.) Regards Charlie - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.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...@socal.rr.com> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org> David Heald <dhe...@gmail.com> - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.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...@socal.rr.com> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org> David Heald <dhe...@gmail.com> - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.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...@socal.rr.com> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org> David Heald <dhe...@gmail.com>
