Hi Folks WRT the IEC standard(s), as I understand it, IEC documents are - and always have been - "advisory documents" which only have "legal force" when they have been officially adopted in a particular country or region (e.g. the EU) by the relevant regulatory or standards body(ies) [ or adopted in contract between two companies]. It is those bodies which will mandate any transition periods that they consider appropriate.
Thus, as far as the US is considered, the CDRH will be the relevant regulatory body. John Allen Thales Defence Bracknell UK -----Original Message----- From: Massey, Doug C. [mailto:[email protected]] Sent: 11 June 2001 21:55 To: 'IEEE Forum' Subject: New laser standards Hello Group - Can anyone direct me to an informative article, link, etc., that summarizes the impact of Amendment 2 to IEC 60825-1, released in January of this year ? I've reviewed the amendment and am aware of the basic differences it brings in classification, but it sure would be nice to have a synopsis of all the changes. Also, does anyone know how soon the changes will be incorporated into a new release of the standard ? The IEC website does not list a target date for release, although the status of edition 1.2 shows it being out for printing since early May. Also, CDRH Laser Notice # 50, published late May, harmonizes, to some degree, 21CFR to the IEC 60825-1 standard, with the notable exception of production line test requirments, record keeping, and some product marking requirements, which are being kept by the CDRH. Has anyone heard if the CDRH product report formats will be changed ? I'm thinking an IEC-60825-1 report, with US national deviations, if you will, may be acceptable to the CDRH at some point in the future, in lieu of their existing published report format. Of greater concern is the lack of a specified transition period and mandatory compliance dates in either standard (at least I can't find them). Will existing laser classifications be grandfathered? When will laser product manufacturers be required to label products according to the new classifications? I can see the new classifications causing much confusion among customers, who may have, say, Class2 laser products, then buying additional units of the same product, which might be labeled as Class 2M, for instance. Thanks for your help. Doug Massey Safety Approvals Engineer LXE, Inc. Norcross, GA., USA Ph. (770) 447-4224 x3607 FAX (770) 447-6928 e-mail: [email protected] Cruise our website at: http:\\www.lxe.com ------------------------------------------- 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," ------------------------------------------- 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,"
