RE: ( More) Laser Safety Questions
Doug - I was in no way implying the flaw was yours. The flaw lies in the practical implementation of the system. Peter -Original Message- From: Massey, Doug C. [mailto:masse...@ems-t.com] Sent: Thursday, March 21, 2002 10:40 AM Peter - I humbly submit that there is no 'flaw' in reminding folks that audits do happen and that they may be subject to one, however rare they may be. Doug Massey --- 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
RE: ( More) Laser Safety Questions
Peter - I humbly submit that there is no 'flaw' in reminding folks that audits do happen and that they may be subject to one, however rare they may be. I don't argue that the agency is understaffed and overworked, and is more concerned with laser light shows and medical device lasers than with low-power, visible laser devices. Regards, Doug Massey Lead Regulatory Engineer LXE, Inc. -Original Message- From: Peter Tarver [mailto:peter.tar...@sanmina-sci.com] Sent: Thursday, March 14, 2002 11:52 AM To: emc-p...@ieee.org Cc: Massey, Doug C. Subject: RE: ( More) Laser Safety Questions All - The only flaw with this is that, based on my previous discussions with CDRH folks, they have very few auditors and no budget to hire more (this was a few years ago). Therefore, by their admission, the primary methods of keeping manufacturers and importers honest is 1) trust in the manufacturer's basic honesty 2) complaints from competitors, customers, etc. 3) field incidents Their primary concern was keeping up with the laser light shows, which they said they could not set aside auditing on (and for good reason). As a test of the presumption, has anyone on this list ever had a CDRH auditor in their facility, other than related to a laser light show? Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services peter.tar...@sanmina-sci.com -Original Message- From: Massey, Doug C. Sent: Wednesday, March 13, 2002 6:51 AM Hi Jeffrey, I've seen answers to this post regarding enforcement of the IEC standard, as well as to the CDRH rules. However, no one has mentioned FDA audits. The FDA does conduct periodic audits at the manufacturer's location as reported in the Product Reports and Annual Reports submitted to them. The auditor will check record keeping, quality control, and product design aspects such as proper labeling. My company has been producing laser products for many years, and only one audit has been conducted, that anyone can remember. I was the representative during that audit, and I commend the auditor on his professionalism and thoroughness. The auditor was a pleasure to work with, but he was very thorough. Rather than a 'let me see what I can nail you on' attitude, the auditor I dealt with had a 'let me see if I can help you improve your compliance process' attitude. The auditor will call ahead and let you know the date for the audit - an appreciated courtesy, but the date is not negotiable. Note that the FDA only has jurisdiction over manufacturing locations within the US. That's why it falls largely to customs to enforce imported goods, I presume. It is also noteworthy that the FDA has a very broad scope and generally has much bigger fish to fry than a manufacturer of low-power laser devices - I think that's why the frequency of audits for manufacturers like us is so low. You may never have the pleasure. For complete information about penalties and other administrative topics, check http://www.fda.gov/cdrh/radhlth/fdcact5c.html , the Electronic Product Radiation Control section of the Federal Food, Drug, and Cosmetic Act. Section 360pp covers Enforcement and Penalties. Hope this helps. Doug Massey Lead Regulatory Engineer LXE, Inc. --- 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
RE: ( More) Laser Safety Questions
All - The only flaw with this is that, based on my previous discussions with CDRH folks, they have very few auditors and no budget to hire more (this was a few years ago). Therefore, by their admission, the primary methods of keeping manufacturers and importers honest is 1) trust in the manufacturer's basic honesty 2) complaints from competitors, customers, etc. 3) field incidents Their primary concern was keeping up with the laser light shows, which they said they could not set aside auditing on (and for good reason). As a test of the presumption, has anyone on this list ever had a CDRH auditor in their facility, other than related to a laser light show? Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services peter.tar...@sanmina-sci.com -Original Message- From: Massey, Doug C. Sent: Wednesday, March 13, 2002 6:51 AM Hi Jeffrey, I've seen answers to this post regarding enforcement of the IEC standard, as well as to the CDRH rules. However, no one has mentioned FDA audits. The FDA does conduct periodic audits at the manufacturer's location as reported in the Product Reports and Annual Reports submitted to them. The auditor will check record keeping, quality control, and product design aspects such as proper labeling. My company has been producing laser products for many years, and only one audit has been conducted, that anyone can remember. I was the representative during that audit, and I commend the auditor on his professionalism and thoroughness. The auditor was a pleasure to work with, but he was very thorough. Rather than a 'let me see what I can nail you on' attitude, the auditor I dealt with had a 'let me see if I can help you improve your compliance process' attitude. The auditor will call ahead and let you know the date for the audit - an appreciated courtesy, but the date is not negotiable. Note that the FDA only has jurisdiction over manufacturing locations within the US. That's why it falls largely to customs to enforce imported goods, I presume. It is also noteworthy that the FDA has a very broad scope and generally has much bigger fish to fry than a manufacturer of low-power laser devices - I think that's why the frequency of audits for manufacturers like us is so low. You may never have the pleasure. For complete information about penalties and other administrative topics, check http://www.fda.gov/cdrh/radhlth/fdcact5c.html , the Electronic Product Radiation Control section of the Federal Food, Drug, and Cosmetic Act. Section 360pp covers Enforcement and Penalties. Hope this helps. Doug Massey Lead Regulatory Engineer LXE, Inc. --- 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
RE: ( More) Laser Safety Questions
Hi Jeffrey, I've seen answers to this post regarding enforcement of the IEC standard, as well as to the CDRH rules. However, no one has mentioned FDA audits. The FDA does conduct periodic audits at the manufacturer's location as reported in the Product Reports and Annual Reports submitted to them. The auditor will check record keeping, quality control, and product design aspects such as proper labeling. My company has been producing laser products for many years, and only one audit has been conducted, that anyone can remember. I was the representative during that audit, and I commend the auditor on his professionalism and thoroughness. The auditor was a pleasure to work with, but he was very thorough. Rather than a 'let me see what I can nail you on' attitude, the auditor I dealt with had a 'let me see if I can help you improve your compliance process' attitude. The auditor will call ahead and let you know the date for the audit - an appreciated courtesy, but the date is not negotiable. Note that the FDA only has jurisdiction over manufacturing locations within the US. That's why it falls largely to customs to enforce imported goods, I presume. It is also noteworthy that the FDA has a very broad scope and generally has much bigger fish to fry than a manufacturer of low-power laser devices - I think that's why the frequency of audits for manufacturers like us is so low. You may never have the pleasure. For complete information about penalties and other administrative topics, check http://www.fda.gov/cdrh/radhlth/fdcact5c.html , the Electronic Product Radiation Control section of the Federal Food, Drug, and Cosmetic Act. Section 360pp covers Enforcement and Penalties. Hope this helps.
Re: (More) Laser Safety Questions
With regards to EN-60825, I would tend to believe (I did not want to say 'assume') that the enforcement parallels the that for CE marking - customs, market surveillance, customer/competitor complaints, etc. In the US I would say it's 'the Feds' - 21CFR 1040 is a 'Code of Federal Regulations'. In this case it would be agents from the FDA. But taking Doug McKean's response into consideration, focusing on OFCS, we can also include NRTLs in enforcement of compliance - at least with respect to the 'initial' compliance of the product. In the ITE standards (950, 1950, 60950) section 4.3.12 references lasers, and notes that equipment shall be so designed that harmful effects to persons and materials affecting safety are prevented . . .or something of that sort. In this case the NRTL (at least the big one that I use) would want to verify this - using 21CFR 1040 and EN 60825 as their guide. I have had to provide not only the 'document received' letter with accession number from the CDRH, but also with the report that I filed. My listing was contingent upon providing that supporting info. If you going to incorporate, and not modify an already classified laser, you would have submit that component manufacturer's supporting data. While perhaps a definitive enforcement 'Agency X' does not exist, there are hurdles that need to be cleared. And considering today's economy, I wouldn't think any of our employers would want to have trouble with 'the Feds'. Just my own opinions . . . . John Juhasz Fiber Options Div. of GE Interlogix 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...@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
RE: ( More) Laser Safety Questions
Jeffery - I have no answer to the enforcement question for the US, but I suspect it's complaint and incident driven, as the EMC regulations historically have been. For NRTLs, the acceptance of previously certified Class I lasers incorporated into other equipment is based on CDRH Laser Notice 42, available as a part of all Laser Notices at http://www.fda.gov/cdrh/radhlth/pdf/laspol01.pdf Links to other useful information is available at http://www.fda.gov/cdrh/radhlth/index.html Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services peter.tar...@sanmina-sci.com -Original Message- From: Collins, Jeffrey Sent: Monday, March 11, 2002 7:32 PM Hello Group, There was a lot of good dialog recently regarding laser safety. Thanks to all that participated Questions: Who enforces the FDA CDRH 1040.1 laser safety standards in the US? How is it enforced? What are the penalties for noncompliance? Who enforces the IEC or EN 60825 laser safety standards in Europe / Globally? How is it enforced? What are the penalties for noncompliance? My questions are stemming from the Class 1 or 1M laser safety requirements particularly in Telecom networks. Some NRTL's and CAB's do not require or do not enforce their clients doing a submittal ( To the FDA ) for installing these types of laser products in your equipment. Their decision was based on your company using a class 1 laser that carries a current NRTL / CAB safety certification which was not modified from it's original design when installed into your products. Thanks in advance, Jeffrey Collins --- 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
Re: ( More) Laser Safety Questions
I don't know. That's a very interesting question. For each separate title in the CFRs there's a separate federal enforcement agency. CFR Title 47 Telecommunications is the FCC. CFR Title 29 Labor (or workplace stuff) is OSHA, etc ... and thus CFR Title 21 Food and Drugs is FDA. That's what happens when new laws come into effect - they try to determine if an enforcement agency already exists. If there is none, then they have to start up a whole new agency. That's why the FCC was started (as were others) when the law was passed regarding telecommunications. So that's why CFR Title 47 is FCC country and CFR Title 21 is FDA country and the two don't mix. Keep in mind that although the laser laws are obviously written for laser safety, much of it is actually for the medical field as well as experimental scientific stuff where the potential for immediate and permanent harm is present. The OSHA requirement specifically addresses equipment being approved by an NRTL. But, with laser products and systems, you apply to the FDA. The FDA is not an NRTL. And it will never be since NRTLs are approved by OSHA. The FDA and OSHA are enforcement federal agencies in parallel with each other and don'tapprove each other's methods. And you get nothing back from the FDA except some letter acknowledging your submittal. Nothing else. There's no approval to speak of. Certainly if you misrepresent your laser product or system and some unfortunate incident were to happen, you would most likely be charged with something from the FDA itself. But not limited to the FDA. The radiological side of things are also touched on by something like 1950 which probably does borrow from the FDA. And since 1950 is used by NRTLs for product compliance, maybe that's how OSHA might also get involved. It sounds as though if you're unfortunate to have some accident befall you, you could potentially get multiple hits from several different federal agencies. I don't know Jeff. Like to hear the others about this. Regards, Doug McKean --- 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
Re: ( More) Laser Safety Questions
Don't forget the European Product Liability Directive (85/374/EEC amended by 99/34/EC) and General Product Safety Directive (92/59/EEC). Neither of these require any approvals or markings, but both require that the state of the art in safety engineering is applied, and this implies the use of all relevant standards, whether harmonised or not, and world-class expert knowledge where international standards are incomplete or inappropriate. Note that both of them include civil liability requirements that can see companies held liable for unlimited financial penalties without the injured party having to prove that the product actually caused the injury. This is variously known as no-fault liability or strict liability, and the larger your company is, the more likely it is to be a target for no-win no-fee lawyers. Whether you complied with these directives or not is determined by a court while you are being sued. It is getting more and more difficult, I am told, for manufacturer to make a successful defence. The UK's implementation of the Product Liability directive is the 1987 Consumer Protection Act. A useful guide to this used to be found at: http://www.lowpay.gov.uk/access/consumer/intro.html. The UK's implementation of the GPSD is the 'General Product Safety Regulations 1994', and a guide used to be available at: http://www.dti.gov.uk/access/safreg94/foreword.html#1 . All the very best! Keith Armstrong www.cherryclough.com In a message dated 12/03/02 15:30:57 GMT Standard Time, andrew_car...@uk.xyratex.com writes: Subj:RE: ( More) Laser Safety Questions Date:12/03/02 15:30:57 GMT Standard Time From:andrew_car...@uk.xyratex.com (Andrew Carson) Sender:owner-emc-p...@majordomo.ieee.org Reply-to: A HREF=mailto:andrew_car...@uk.xyratex.com;andrew_car...@uk.xyratex.com/A (Andrew Carson) To:jcoll...@ciena.com (Collins, Jeffrey), emc-p...@ieee.org Jeff In response the second part of your question on who enforces EN60825 within Europe. If the laser device is used on a product that falls under on of the CE (or New Approach Directives ) eg. The LVD. Then the enforcement will be like any other CE marked goods. Which varies from country to country, bt for the UK the CE mark is watched over by the Depeartment of Trade and Industy and the The Office of Trading Standards. Now complaice to a CE marking directive carries penalities ranging from Finess, porduct recal and worst case upto 2 years jail time for the person signing the DOC. The enforcement is made agaist the perosn, not the company. Starngely though, if your Laser porduct does not fall under a CE directive, there is no piece of European legistation saying it needs to meet EN60825, beyond the old Product Safety Directive (Which does not require a CE mark). In your case, if you are incororating an already CDRH registered Class 1 device into your product without alteration. Then you do not need to re register your overall product. This is covered by a CDRH notice to the laser industry No. 42. Andrew Carson - Senior Compliance Engineer, Xyratex, UK Phone: +44 (0)23 9249 6855 Fax: +44 (0)23 9249 6014 -Original Message- From: Chris Maxwell [mailto:chris.maxw...@nettest.com] Sent: 12 March 2002 13:22 To: Collins, Jeffrey; emc-p...@ieee.org Subject: RE: ( More) Laser Safety Questions I believe that OSHA enforces the CDRH laser safety guidelines in the workplace. I'm not sure about consumer goods...Possibly the Consumer Product Safety Commission? Penalties for non-compliance would be the typical fines, recalls ... handed out by OSHA or CPSC. -Original Message- From:Collins, Jeffrey [SMTP:jcoll...@ciena.com] Sent:Monday, March 11, 2002 10:32 PM To:'emc-p...@ieee.org' Subject:( More) Laser Safety Questions Hello Group, There was a lot of good dialog recently regarding laser safety. Thanks to all that participated Questions: Who enforces the FDA CDRH 1040.1 laser safety standards in the US? How is it enforced? What are the penalties for noncompliance? Who enforces the IEC or EN 60825 laser safety standards in Europe / Globally? How is it enforced? What are the penalties for noncompliance? My questions are stemming from the Class 1 or 1M laser safety requirements particularly in Telecom networks. Some NRTL's and CAB's do not require or do not enforce their clients doing a submittal ( To the FDA ) for installing these types of laser products in your equipment. Their decision was based on your company using a class 1 laser that carries a current NRTL / CAB safety certification which was not modified from it's original design when installed into your products. Thanks in advance, Jeffrey Collins Sr. HW Engineering Manager EMC/ NEBS/ Safety/ Reliability CIENA Core Switching Division 10480 Ridgeview Court
RE: ( More) Laser Safety Questions
Jeff In response the second part of your question on who enforces EN60825 within Europe. If the laser device is used on a product that falls under on of the CE (or New Approach Directives ) eg. The LVD. Then the enforcement will be like any other CE marked goods. Which varies from country to country, bt for the UK the CE mark is watched over by the Depeartment of Trade and Industy and the The Office of Trading Standards. Now complaice to a CE marking directive carries penalities ranging from Finess, porduct recal and worst case upto 2 years jail time for the person signing the DOC. The enforcement is made agaist the perosn, not the company. Starngely though, if your Laser porduct does not fall under a CE directive, there is no piece of European legistation saying it needs to meet EN60825, beyond the old Product Safety Directive (Which does not require a CE mark). In your case, if you are incororating an already CDRH registered Class 1 device into your product without alteration. Then you do not need to re register your overall product. This is covered by a CDRH notice to the laser industry No. 42. Andrew Carson - Senior Compliance Engineer, Xyratex, UK Phone: +44 (0)23 9249 6855 Fax: +44 (0)23 9249 6014 -Original Message- From: Chris Maxwell [mailto:chris.maxw...@nettest.com] Sent: 12 March 2002 13:22 To: Collins, Jeffrey; emc-p...@ieee.org Subject: RE: ( More) Laser Safety Questions I believe that OSHA enforces the CDRH laser safety guidelines in the workplace. I'm not sure about consumer goods...Possibly the Consumer Product Safety Commission? Penalties for non-compliance would be the typical fines, recalls ... handed out by OSHA or CPSC. -Original Message- From: Collins, Jeffrey [SMTP:jcoll...@ciena.com] Sent: Monday, March 11, 2002 10:32 PM To: 'emc-p...@ieee.org' Subject: ( More) Laser Safety Questions Hello Group, There was a lot of good dialog recently regarding laser safety. Thanks to all that participated Questions: Who enforces the FDA CDRH 1040.1 laser safety standards in the US? How is it enforced? What are the penalties for noncompliance? Who enforces the IEC or EN 60825 laser safety standards in Europe / Globally? How is it enforced? What are the penalties for noncompliance? My questions are stemming from the Class 1 or 1M laser safety requirements particularly in Telecom networks. Some NRTL's and CAB's do not require or do not enforce their clients doing a submittal ( To the FDA ) for installing these types of laser products in your equipment. Their decision was based on your company using a class 1 laser that carries a current NRTL / CAB safety certification which was not modified from it's original design when installed into your products. Thanks in advance, Jeffrey Collins Sr. HW Engineering Manager EMC/ NEBS/ Safety/ Reliability CIENA Core Switching Division 10480 Ridgeview Court, Cupertino, CA. 95014 (408) 366-4806, Fax (408) 366-4866 jcoll...@ciena.com http://www.ciena.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: 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 --- 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 --- 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
RE: ( More) Laser Safety Questions
I believe that OSHA enforces the CDRH laser safety guidelines in the workplace. I'm not sure about consumer goods...Possibly the Consumer Product Safety Commission? Penalties for non-compliance would be the typical fines, recalls ... handed out by OSHA or CPSC. -Original Message- From: Collins, Jeffrey [SMTP:jcoll...@ciena.com] Sent: Monday, March 11, 2002 10:32 PM To: 'emc-p...@ieee.org' Subject: ( More) Laser Safety Questions Hello Group, There was a lot of good dialog recently regarding laser safety. Thanks to all that participated Questions: Who enforces the FDA CDRH 1040.1 laser safety standards in the US? How is it enforced? What are the penalties for noncompliance? Who enforces the IEC or EN 60825 laser safety standards in Europe / Globally? How is it enforced? What are the penalties for noncompliance? My questions are stemming from the Class 1 or 1M laser safety requirements particularly in Telecom networks. Some NRTL's and CAB's do not require or do not enforce their clients doing a submittal ( To the FDA ) for installing these types of laser products in your equipment. Their decision was based on your company using a class 1 laser that carries a current NRTL / CAB safety certification which was not modified from it's original design when installed into your products. Thanks in advance, Jeffrey Collins Sr. HW Engineering Manager EMC/ NEBS/ Safety/ Reliability CIENA Core Switching Division 10480 Ridgeview Court, Cupertino, CA. 95014 (408) 366-4806, Fax (408) 366-4866 jcoll...@ciena.com http://www.ciena.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: 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 --- 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
( More) Laser Safety Questions
Hello Group, There was a lot of good dialog recently regarding laser safety. Thanks to all that participated Questions: Who enforces the FDA CDRH 1040.1 laser safety standards in the US? How is it enforced? What are the penalties for noncompliance? Who enforces the IEC or EN 60825 laser safety standards in Europe / Globally? How is it enforced? What are the penalties for noncompliance? My questions are stemming from the Class 1 or 1M laser safety requirements particularly in Telecom networks. Some NRTL's and CAB's do not require or do not enforce their clients doing a submittal ( To the FDA ) for installing these types of laser products in your equipment. Their decision was based on your company using a class 1 laser that carries a current NRTL / CAB safety certification which was not modified from it's original design when installed into your products. Thanks in advance, Jeffrey Collins Sr. HW Engineering Manager EMC/ NEBS/ Safety/ Reliability CIENA Core Switching Division 10480 Ridgeview Court, Cupertino, CA. 95014 (408) 366-4806, Fax (408) 366-4866 jcoll...@ciena.com http://www.ciena.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: 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
