The infamous Laser notice 50. The following is Excerpted from Federal Register / Vol. 66, No. 144 / Thursday, July 26, 2001 / Notices under the heading titled, "Laser ProductsConformance with IEC 608251, Am. 2 and IEC 60601222 (Laser Notice 50)."
"CDRH intends to amend its standards for laser products at 21 CFR 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC 608251 and 60601222 standards. "This guidance supersedes: Labeling of Laser Products, August 15, 1995 (Laser Notice 45). "In order to receive Laser ProductsConformance with IEC 608251, Am. 2 Conformance with IEC 608251, Am. 2' via your fax machine, call the CDRH Facts-On-Demand system at 8008990381 or 3018270111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number (1346) followed by the pound sign (#). "www.fda.gov/cdrh/radhlth/index.html under the index heading for Lasers, Including Light Shows as a Notices to Industry. Scroll to number 92 in the list of notices." When I went to the web site this morning, Laser Notice 50 was not yet included in the collection of Laser Notices. Similarly, when I tried to use the fax back system, I was told there is no such document. On the bright side, a little digging revealed the document at: http://www.fda.gov/cdrh/comp/guidance/1346.pdf The document allows latitude in many areas of 1040.10, but still requires application of several other provisions in 1040. It make the certification label look nasty. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina Homologation Services 355 E. Trimble Rd. San Jose, CA 95131-1218 V: 408-474-1322 F: 408-474-1318 M: 408-234-3529 [email protected] ------------------------------------------- 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: Michael Garretson: [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://www.rcic.com/ click on "Virtual Conference Hall,"
