Kenneth, Typically the CDRH will send you two letters. The first one lets you know that they received the report, and they issue you an accession number. A second letter (about 3 months later) notes that they have reviewed report and (provided they find nothing wrong) will tell you that no further info is required. THAT is their 'approval' (for lack of a better word) letter. That is the letter you provide to UL. The engineer at the UL office near me (Melville) required the report that I submitted to the CDRH. I had no problem giving them that. What would've happened if I didn't give them that info? Would they hold up approval? I don't know. I usually have all my 'ducks in a row' so I have no idea.
Basically the same holds true for EN 60950 compliance. You need to demonstrate compliance with IEC 825 (EN 60825). 'Compliance' may be a misnomer. You need to demonstrate that your equipment is properly classified and that the appropriate controls/warnings/instructions, as/where applicable, are in pplace for the corresponding classification. Here's the links for the CDRH. (You will need to purchase 825. I have not found any good on-line information). http://www.fda.gov/cdrh/radhlth/cfr/21cfr1040.10.pdf http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=http %3A%2F%2Fwww%2Efda%2Egov%2Fcdrh%2Fradhlth%2Flaser%2Ehtml&DocOffset=10&DocsFo und=134&QueryZip=Laser&Collection=C4&SearchUrl=http%3A%2F%2Fwww%2Everity%2Ef da%2Egov%2Fsearch97cgi%2Fs97%5Fcgi%2Eexe%3Faction%3DSearch%26QueryZip%3DLase r%26ResultTemplate%3Dstndrslp%252Ehts%26QueryText%3DLaser%26Collection%3DC4% 26ResultStart%3D1%26ResultCount%3D10&hlnavigate=ALL John A. Juhasz Product Qualification & Compliance Engineer Fiber Options, Inc. 80 Orville Dr. Suite 102 Bohemia, NY 11716 USA Tel: 631-419-2324 (direct) Fax: 631-567-8322 -----Original Message----- From: Kenneth McCormick [mailto:kmccormick...@hotmail.com] Sent: Monday, November 20, 2000 6:08 PM To: emc-p...@majordomo.ieee.org 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson: pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
