RE: Two Questions concerning the subject of Laser Safety
Josh, I agree with your message below. It may not have been clear in my first email. The FDA's Laser Notice 50 allows the use of EN 60825-1 for the "technical" aspects of laser safety, such as: determination of the laser classification, how to label the device, what information to put in the manual... However, as you state below, the FDA/CDRH still demands that manufacturers meet the documentation, reporting and tracking requirements (units tracked by serial number, model number, reports to the CDRH...) listed in CFR 21, Part 1040. Chris > -Original Message- > From: Joshua Wiseman [SMTP:jwise...@printronix.com] > Sent: Wednesday, June 19, 2002 6:27 PM > To: Chris Maxwell; John Juhasz; Davis, Mike; Emc-Pstc (E-mail) > Subject: RE: Two Questions concerning the subject of Laser Safety > > Chris, > > As I recall Laser Notice 50 does not exempt you from the record keeping and > report of the CFR 21, only the qualification aspects. > > Regards, > Josh > > > --- 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...@attbi.com 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"
RE: Two Questions concerning the subject of Laser Safety
Chris, As I recall Laser Notice 50 does not exempt you from the record keeping and report of the CFR 21, only the qualification aspects. Regards, Josh -Original Message- From: Chris Maxwell [mailto:chris.maxw...@nettest.com] Sent: Wednesday, June 19, 2002 1:24 PM To: John Juhasz; Davis, Mike; Emc-Pstc (E-mail) Subject: RE: Two Questions concerning the subject of Laser Safety As a follow up to John's reply below: If you are considering taking some kind of class or hiring a consultant for laser safety; you may want to consider buying a copy of the latest version of EN 60825-1. The standard is very thorough, providing methods to determine the class of laser devices either by measurement or calculation. It also has tables of requirements for labeling, manual information, interlocking...requirements for different classes of lasers. The good thing is, the CDRH has issued Laser Notice 50 which essentially states that you can use EN 60825-1 to meet the technical aspects (laser classification, labeling...) of the CDRH requirements. This greatly simplifies the technical aspects of laser compliance. It also means that your copy of EN 60825 will help you with foreign and US laser safety compliance. Chris Maxwell | Design Engineer - Optical Division email chris.maxw...@nettest.com | dir +1 315 266 5128 | fax +1 315 797 8024 NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA web www.nettest.com | tel +1 315 797 4449 | > -Original Message- > From: John Juhasz [SMTP:john.juh...@ge-interlogix.com] > Sent: Wednesday, June 19, 2002 12:57 PM > To: 'Davis, Mike'; Emc-Pstc (E-mail) > Subject: RE: Two Questions concerning the subject of Laser Safety > > > Mike, > > Go to the following link of the CDRH (Center for Devices and Radiological > Health). They're the ones to whom the > reports will be sent. There are further links to information that will be > very useful to you and should answer most > of the questions you posed below. > > http://www.fda.gov/cdrh/radhlth/index.html > > Simply put, at this moment in the US LEDs are not regulated. But the CDRH > will be aligning the regs with Europe (EN 60825) where > verification that the LEDs are safe is required. > > GE Interlogix > > John A. Juhasz > > Fiber Options Div. > Bohemia, NY > > > > --- 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...@attbi.com 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"
RE: Two Questions concerning the subject of Laser Safety
As a follow up to John's reply below: If you are considering taking some kind of class or hiring a consultant for laser safety; you may want to consider buying a copy of the latest version of EN 60825-1. The standard is very thorough, providing methods to determine the class of laser devices either by measurement or calculation. It also has tables of requirements for labeling, manual information, interlocking...requirements for different classes of lasers. The good thing is, the CDRH has issued Laser Notice 50 which essentially states that you can use EN 60825-1 to meet the technical aspects (laser classification, labeling...) of the CDRH requirements. This greatly simplifies the technical aspects of laser compliance. It also means that your copy of EN 60825 will help you with foreign and US laser safety compliance. Chris Maxwell | Design Engineer - Optical Division email chris.maxw...@nettest.com | dir +1 315 266 5128 | fax +1 315 797 8024 NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA web www.nettest.com | tel +1 315 797 4449 | > -Original Message- > From: John Juhasz [SMTP:john.juh...@ge-interlogix.com] > Sent: Wednesday, June 19, 2002 12:57 PM > To: 'Davis, Mike'; Emc-Pstc (E-mail) > Subject: RE: Two Questions concerning the subject of Laser Safety > > > Mike, > > Go to the following link of the CDRH (Center for Devices and Radiological > Health). They're the ones to whom the > reports will be sent. There are further links to information that will be > very useful to you and should answer most > of the questions you posed below. > > http://www.fda.gov/cdrh/radhlth/index.html > > Simply put, at this moment in the US LEDs are not regulated. But the CDRH > will be aligning the regs with Europe (EN 60825) where > verification that the LEDs are safe is required. > > GE Interlogix > > John A. Juhasz > > Fiber Options Div. > Bohemia, NY > > > > --- 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...@attbi.com 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"
RE: Two Questions concerning the subject of Laser Safety
Mike - See below. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services San Jose, CA peter.tar...@sanmina-sci.com > -Original Message- > From: Davis, Mike > Sent: Wednesday, June 19, 2002 6:59 AM > > 1.Are manufacturers required by the FDA to record serial numbers of Laser modules. Where is this requirement located? Does this apply to photodiodes also? A) Not in so few words. The requirements imply the need for a tracking method by way of a QC program, but nothing is specifically identified. Also, if there's a field incident, traceability to a manufacturing lot would likely become an issue, especially if the field incident is serious enough to warrant a recall (you would, no doubt, prefer to recall only some modules from the field, rather than all of them). S/Ns are the most common method I've seen used for this. B) photodiodes are not controlled by the FDA; neither are noncoherent LED sources > 2.I have a concern of what I need to know about Laser safety but was afraid to ask (because it would cost more than my compliance budget ($0) would allow without manager approval). In other words (what is the second question?... I am getting there.) I am looking to hire a consultant or take a course. My supervisor wants me to create for him a proposal answering the type of questions that support the need to either attend a course or have a consultant educate me or our professionals here so that he can decide whether or not we need to hire a consultant, etc, etc. To keep this short, I will paraphrase by saying that the type of questions he would like to have answered is it worth the expense to getting smart, as engineers and a manufacturer of ITE, in the manufacturing of laser systems? I believe it's worth "getting smart." I recommend (you just missed the last one): International Laser Safety Conference March 10-13, 2003 Jacksonville, FL http://www.laserinstitute.org/conferences/ilsc2003/index2003 .htm > Here is my question... > Is there information available that summarizes the responsibilities to Laser Safety of Compliance, Design, Manufacturing, and Test Engineers that manufacture laser systems? Refer to 21CFR and the CDRH web site for all of this. You'll find copies of the initial and annual reports and links to 21CFR. Some of the information you want is in early sections of Section 1040 (1040.01, .02) so don't ignore them and only review 1040.10. http://www.fda.gov/cdrh/ --- 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...@attbi.com 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"
RE: Two Questions concerning the subject of Laser Safety
Mike, Go to the following link of the CDRH (Center for Devices and Radiological Health). They're the ones to whom the reports will be sent. There are further links to information that will be very useful to you and should answer most of the questions you posed below. http://www.fda.gov/cdrh/radhlth/index.html Simply put, at this moment in the US LEDs are not regulated. But the CDRH will be aligning the regs with Europe (EN 60825) where verification that the LEDs are safe is required. GE Interlogix John A. Juhasz Fiber Options Div. Bohemia, NY > -Original Message- > From: Davis, Mike [mailto:mda...@c-cor.net] > Sent: Wednesday, June 19, 2002 9:59 AM > To: Emc-Pstc (E-mail) > Subject: Two Questions concerning the subject of Laser Safety > > 1.Are manufacturers required by the FDA to record serial numbers of > Laser modules. Where is this requirement located? Does this apply to > photodiodes also? > > 2.I have a concern of what I need to know about Laser safety but was > afraid to ask (because it would cost more than my compliance budget ($0) > would allow without manager approval). In other words (what is the second > question?... I am getting there.) I am looking to hire a consultant or > take a course. My supervisor wants me to create for him a proposal > answering the type of questions that support the need to either attend a > course or have a consultant educate me or our professionals here so that > he can decide whether or not we need to hire a consultant, etc, etc. To > keep this short, I will paraphrase by saying that the type of questions he > would like to have answered is it worth the expense to getting smart, as > engineers and a manufacturer of ITE, in the manufacturing of laser > systems? > > Here is my question... > Is there information available that summarizes the responsibilities to > Laser Safety of Compliance, Design, Manufacturing, and Test Engineers that > manufacture laser systems? > > You may respond either on or off line. Thanks in Advance! > > > Michael S. Davis > Compliance Engineer > C-C0R.net > Tel: 203.630.5788 > Fax: 203.630.5762 > mike.da...@c-cor.net > > --- 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...@attbi.com 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"
