We had to supply accession numbers for all of the lasers used in our equipment and submit a copy of our FDA report to satisfy UL. For CB, we have to provide certificates for each laser against EN60825 - this is more difficult, as some European component manufacturers are self-declaring, meaning a full assessment of the component is required.
Dave Wilson -----Original Message----- From: Kenneth McCormick [mailto:[email protected]] Sent: Monday, November 20, 2000 3:08 PM To: [email protected] Subject: Lasers in ITE Equipment I am working with a client who has posed a question that I am not sure that I can accurately answer. What are the NRTLs (and for that matter, other test laboratories) requiring for Laser Certifications. Annex NAE of UL1950/CSA C22.2 No 950 is an INFORMATIVE annex(and mentions the regultory requirements of a CDRH Report in US and a REDR in Canada), however Clause 4.3.12 leads me to believe that proof of compliance with these regulatory requirements is REQUIRED by the standard. With EN60950, compliance with IEC825 is required by clause 4.3.12. Are the certifying laboratories witholding certification until the manufacturer can show compliance with the applicable requirements, or are they simply stating that compliance with the applicable laser requirements is the responsibility of the manufacturer? If they are holding certification, what proof will typically meet their requirements? Will documentation showing that the application has been submitted to the CDRH suffice, or do they typically require the final reports and approval issued by CDRH? What laser markings, if any, are these laboratories requiring in their compliance reports? Is anyone aware of some documents that summarize the requirements of the CFR & IEC825? Thank you in advance, Kenneth ____________________________________________________________________________ _________ Get more from the Web. FREE MSN Explorer download : http://explorer.msn.com ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
