I tried looking real hard for free downloadable ANSI specs and couldn't find them - I had to buy them.
Regarding labelling, there have been efforts (not sure of the status at this time - is there anyone out there who knows?) to harmonize the EN 60825 and 21CFR1040 to make it easier on manufacturers. As the final laser classifications are parallel (it's the methodology that has differences) the FDA, in the interest of manufacturer satisfaction(?) has been allowing the use of the Classification/Warning labels as described in EN 60825. But you still have to add the FDA-CDRH label "This product complies with FDA Radiation Performance Standard 21 CFR Subpart J" Hope this helps. John Juhasz Fiber Options Bohemia, NY -----Original Message----- From: Davis, Mike [mailto:mda...@c-cor.net] Sent: Wednesday, March 06, 2002 9:26 AM To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt'; emc-p...@majordomo.ieee.org Subject: RE: Laser Safety I agree with Doug and with John but, I have the same question. And I will add, Doug is speaking of the FDA-CDRH requirement for the US. But, to ascertain what the European mode is, this requires a single-fault condition for classification as described by John Juhasz. That, I understand. John, is there a free downloadable copy of ANSI Z136.1 and .2 specs? I have used the calculations to determine the classification of a laser based on the no fault and a single fault mode. These lasers are operating in a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a 1310nmn and a 1550nm laser that I used to determine that the lasers either do or do not fall within the Class 1 laser classification. Another question... Can the same label be used for FDA as for IEC? Has anyone had any feedback or problems with laser labels that deviated from recommended markings by the 21 CFR or IEC 825-1? ------------------------------------------- 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
