Lab Equipment/WEEE RoHS
Greetings I am trying to determine whether our laboratory equipment is required to comply with the RoHS and WEEE Directives at this time. We do have some instruments for use as IVD and realize that they do fall under the scope of the WEEE Directive as Category 8 "Medical Devices: Laboratory Equipment for in-vitro diagnosis." However, we are not sure about our thermal cyclers, DNA sequencers, mass spectrometers, etc. The scope currently includes Category 9 called "Monitoring and Control Instruments" and gives examples including "Measuring, weighing, or adjusting appliances for household or as laboratory equipment". Our instruments do not seem like any of the other examples for the same category, yet they do measure things. Our mass spectrometers can use flight time of ions to help determine the mass and thus the original constitution of the sample. In addition, Member States may specify laboratory equipment within their laws that support the WEEE Directive. As an example, the current Swedish WEEE laws on producer responsibility clearly states that laboratory equipment is included. Your thoughts on this subject are appreciated. Regards Joe Martin Applied Biosystems marti...@appliedbiosystems.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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Safety standard
Question on which safety standard to use: The item is a piece of test equipment that was designed in-house for use in-house. It will be shipped to Europe. Is the correct safety standard EN 61010-1? Thanks. Dave Cuthbert Micron Technology 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: FDA registration of laser
Chris - Your rationale for not resubmitting is valid *if* the GBICs are Certified as Class I (I haven't seen one yet that isn't). Your rationale for resubmitting is missing some what ifs. Specifically, if you remove (or cover with a label) any of the required markings or use the device outside the manufacturers' intended application (voltage, modulation rates, etc.). This is all in Laser Notice 42. With regard to modulation rates, I reviewed one manufacturer's certifications for one of their GBICs and discovered that the IEC60825-1, Class 1 certification was dependant upon not having the modulation disappear. This did not appear in the CDRH report, but seeing this led me to believe the risks associated with its use without fault testing of the modulation circuitry were greater than I was willing to accept. Certification reports for other GBICs >from the same manufacturer did not include this caveat. I don't know if all GBICs are subject to the same consideration or if some fail-safes are built into them. If they are subject to the same consideration, it should be so noted in their product literature and the certifications and the manufacturers should be taken to task for putting a yoke on end-users. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services San Jose, CA peter.tar...@sanmina-sci.com > From: Chris Maxwell > Sent: Wednesday, June 11, 2003 11:04 AM > > our current thinking is that we don't need to > re-submit the GBICs to the CDRH > The only reason that I could see for > re-submitting the GBICs would be if we tried to > re-label them and sell them under a Nettest part > number, which we don't. > > Does anybody see a hole in this reasoning? > > Thanks, > > Chris Maxwell 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: FDA registration of laser
Nope, you are absolutely correct on the GBIC's or the new smaller pluggable LC connector optics. You are just a distributor of those under the laser guidelines. Again, its a fully contained module that you make no changes to, and they have no controls or failure modes that you could induce to change the output of the laser. Gary
RE: LED Emissions
The answer to my questions can be found in Clause 5.2.2.4 of TR 60825-9. A rectangular aperture is required for oblong sources and the method of measurement is presented in that clause - it isn't easy. Sigh. > -Original Message- > From: WOODS, RICHARD > Sent: Wednesday, June 11, 2003 9:50 AM > To: 'emc-pstc' > Subject: LED Emissions > > I am attempting to measure, in accordance with IEC 60825-1+A1 +A2, the > size of the apparent source of a LED plastic fiber optic driver when the > fiber is removed. The driver assembly consists of a visible red LED, clear > magnifying lens and a barrel into which the 2.2 mm dia plastic fiber cable > is inserted up to the lens surface. When I focus a relay lens near the tip > of the barrel, I can find a minimal size image that consists of a bright > center with concentric rings (reflections along the length of the barrel). > The image diameter is about 2.3 mm. When I focus further inside the > assembly, I can find a smaller virtual image of the magnified LED surface > - about 1 mm diameter. Which of these two images is considered to be the > apparent source? > > If the image near the tip of the barrel is the apparent source, it is a > near circular image and I can use a circular aperture to determine the > apparent size. If the apparent source is the one inside the barrel, the > image is square (the LED die), and the standard appears to say that I must > use a rectangular aperture. Is this correct or may I use a circular > aperture? If so, the standard does not provide the procedure to determine > the apparent size using a rectangular aperture. Any hints? > > Richard Woods > Sensormatic Electronics > Tyco International > 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: FCC and Hi Temp operation
My recommendation is to look at the radio performance issues as well as the regulatory. It is possible that you have no FCC compliance issues but the radio does not perform! The FCC could not care less if your radio works or not. Kurt Kurt Fischer HYPER Corporation 1279 Quarry Lane, Suite B Pleasanton, CA 94566-8499 +1.925.462.9105 ext. 205 (Voice) +1.925.577.5517 (PCS) +1.925.280.7751 (Fax) mailto:kurt.fisc...@hyperinterop.com www.hyperinterop.com From: richwo...@tycoint.com [mailto:richwo...@tycoint.com] Sent: Wednesday, June 11, 2003 9:58 AM To: chuck.bu...@cubic.com; emc-p...@majordomo.ieee.org Subject: RE: FCC and Hi Temp operation My recommendation is for the supplier to provide you with a device that they certify to operate within the scope of their FCC Grant at your specified temp range. In other words, place the ownership of the problem back on the supplier. Let them determine if they need to resumit data to the FCC for the higher temp operation. Richard Woods Sensormatic Electronics Tyco International From: Burns, Chuck [mailto:chuck.bu...@cubic.com] Sent: Wednesday, June 11, 2003 11:25 AM To: emc-p...@majordomo.ieee.org Subject: FCC and Hi Temp operation Hello, everyone. We are integrating a purchased 802.11b device into our product, but face ambient temperature requirements up to 80 degrees C. This brings up two problems: 1. Will it work at that temperature? One vendor advertises 55 degrees max, another 70 but with an offer to "screen" products at 80. 2. What are the FCC requirements? The FCC Rules for the 2.45 GHz band, 15.249, specify a frequency tolerance of 0.001% over the -20 to +50 degree range, but do not specifically address higher temperatures. Do we simply fall back onto the more general provisions of 15.215, keeping the 20dB bandwidth signal within the designated band, with a recommendation to keep it within the central 80% of the permitted range? Since we are not manufacturing the transmitter, which already carries FCC certification, who is responsible to the FCC for ensuring compliance at our extreme temperature? Regards, Chuck Burns Manager of Compliance Cubic Transportation Systems, Inc. 5650 Kearny Mesa Road San Diego, CA 92111 Tel.: (858) 627-4562 Fax: (858) 292-9987 chuck.bu...@cubic.com
RE: FDA registration of laser
I want to leech off of this question; I hope that I don't get it off track. We currently produce a module that use GBICs. For the unfamiliar, a GBIC is an optical transceiver for gigabit ethernet. Our quality personnel handle CDRH submissions; and our current thinking is that we don't need to re-submit the GBICs to the CDRH for the following reasons: 1. We don't make them. 2. They are self contained. 3. They are already CE marked and submitted to the CDRH by their own manufacturer. 4. The original manufacturer is clearly labeled on the units. 5. They are universal and installed by the customer. Our product could use any appropriate GBIC. We offer a couple of brands to our customers. However, to me it still wouldn't make sense for us to re-submit these brands to the CDRH. Our customers could install any brand of GBIC. The only reason that I could see for re-submitting the GBICs would be if we tried to re-label them and sell them under a Nettest part number, which we don't. Does anybody see a hole in this reasoning? Thanks, 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 | > 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: FCC and Hi Temp operation
Hi Chuck, The device in question would fall under 15.247, which has no extreme temperature requirement in the U.S. If the WLAN device was tested for use in the EU the European Norm (EN 300 328) does involve extreme temperature testing of -20 to +55 C, unless it is for indoor use or controlled environment only, in which case they would still have to test from 0 to + 35 C. If it is a plug in device for use in a host system, the standard only requires that the WLAN device meet the temperature extremes declared for the host system. I hope that you find this info helpful. Best Regards, Barbara From: Burns, Chuck [mailto:chuck.bu...@cubic.com] Sent: Wednesday, June 11, 2003 8:25 AM To: emc-p...@majordomo.ieee.org Subject: FCC and Hi Temp operation Hello, everyone. We are integrating a purchased 802.11b device into our product, but face ambient temperature requirements up to 80 degrees C. This brings up two problems: 1. Will it work at that temperature? One vendor advertises 55 degrees max, another 70 but with an offer to "screen" products at 80. 2. What are the FCC requirements? The FCC Rules for the 2.45 GHz band, 15.249, specify a frequency tolerance of 0.001% over the -20 to +50 degree range, but do not specifically address higher temperatures. Do we simply fall back onto the more general provisions of 15.215, keeping the 20dB bandwidth signal within the designated band, with a recommendation to keep it within the central 80% of the permitted range? Since we are not manufacturing the transmitter, which already carries FCC certification, who is responsible to the FCC for ensuring compliance at our extreme temperature? Regards, Chuck Burns Manager of Compliance Cubic Transportation Systems, Inc. 5650 Kearny Mesa Road San Diego, CA 92111 Tel.: (858) 627-4562 Fax: (858) 292-9987 chuck.bu...@cubic.com
RE: Interconnecting Cables
Hello Richard, You mentioned that the cable contains hazardous voltage. In order to determine what type of interconnecting cable is suitable to use, you need to find out whether or not the cable in question is supplied by a limited power source (LPS) or NEC Class 2. For non-LPS applications, if the cable is less than 3.05 m in length, a suitably rated "jacketed appliance wiring material (AWM) is required. Also, power supply cords described in EN/UL 60950:2000 Annex NAE (3.2.4) and Table NAE.4 can be used. You mentioned Style 2464. Style 2464 is a jacketed AWM, rated 300 V 80 C. As long as the length of the cable is maximum 3.05 m and marked VW-1 or FT-1 (flammability rating), it should be suitable. For non-LPS applications, if the cable exceeds 3.05 m in length, then a Listed cable designated in the NEC (e.g. Type DP) is needed. For LPS applications, the only requirement is that the cable should be AWM, maximum 3.05 m in length and marked VW-1 or FT-1. There are no requirements in terms of Style, temperature and voltage ratings. Hope this helps. Rgds, Sylvia From: richwo...@tycoint.com [mailto:richwo...@tycoint.com] Sent: Wednesday, June 11, 2003 5:59 AM To: emc-p...@majordomo.ieee.org Subject: FW: Interconnecting Cables I didn't receive any comments at all, so I am trying again. Any comments would be welcomed. > -Original Message- > From: WOODS, RICHARD > Sent: Tuesday, June 03, 2003 10:58 AM > To: 'emc-pstc' > Subject: Interconnecting Cables > > I need to determine the robustness requirements for the outer insulation > of an interconnecting cable for ITE when the cable contains hazardous > voltages and when the cable will be in the same physical environment as > the power cord. Clause 1.5.5 of EN 60950:2000 says that the cable must > comply with the relevant requirements of the standard, but those > requirements are not further specified in the standard. One might infer > that the insulation must be no lighter than the requirements for power > cords specified in Clause 3.2.5, but that is not clear. In particular, I > need to determine if properly voltage rated computer interconnect cables > (e.g., UL style 2464) are sufficiently robust to comply with the standard. > Any suggestions on acceptable cable types/styles would be appreciated. > > Richard Woods > Sensormatic Electronics > Tyco International > 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: FDA registration of laser
I think I agree with the laser 42 reference, but I would be a little careful. The notice applies to units that are not only complete in their construction and as such their output cannot be affected by the circuits into which they are being installed. E. g. If the drive voltage increases to the module, the module must have mechanisms to prevent an increase in output power. A good example are the optical transceivers used in the Ethernet and Sonnet world. They are small complete transceivers that may be ordered and installed into equipment after manufacture simply by plugging them into and existing receptacle. Many of these units have class II lasers, but they have been evaluated to insure that a fault in the end use equipment can't cause the modules to produce greater than class I laser outputs, even in double fault conditions. I don't know if the same is true for the laser modules used to construct CD's and DVD etc. If it is then notice 42 is indeed appropriate. Gary
RE: FCC and Hi Temp operation
My recommendation is for the supplier to provide you with a device that they certify to operate within the scope of their FCC Grant at your specified temp range. In other words, place the ownership of the problem back on the supplier. Let them determine if they need to resumit data to the FCC for the higher temp operation. Richard Woods Sensormatic Electronics Tyco International From: Burns, Chuck [mailto:chuck.bu...@cubic.com] Sent: Wednesday, June 11, 2003 11:25 AM To: emc-p...@majordomo.ieee.org Subject: FCC and Hi Temp operation Hello, everyone. We are integrating a purchased 802.11b device into our product, but face ambient temperature requirements up to 80 degrees C. This brings up two problems: 1. Will it work at that temperature? One vendor advertises 55 degrees max, another 70 but with an offer to "screen" products at 80. 2. What are the FCC requirements? The FCC Rules for the 2.45 GHz band, 15.249, specify a frequency tolerance of 0.001% over the -20 to +50 degree range, but do not specifically address higher temperatures. Do we simply fall back onto the more general provisions of 15.215, keeping the 20dB bandwidth signal within the designated band, with a recommendation to keep it within the central 80% of the permitted range? Since we are not manufacturing the transmitter, which already carries FCC certification, who is responsible to the FCC for ensuring compliance at our extreme temperature? Regards, Chuck Burns Manager of Compliance Cubic Transportation Systems, Inc. 5650 Kearny Mesa Road San Diego, CA 92111 Tel.: (858) 627-4562 Fax: (858) 292-9987 chuck.bu...@cubic.com
Re: FCC and Hi Temp operation
The first thing to do is to check the component temperature ratings to see if you will even meet the parts manufacturers operating limits. Many commercial components are rated at 70C, meaning that the parts vendors only guarantee the operation up to that point, after that you are on you own. They will likely have some level of safety margin, but I wouldn't be betting my equipment and company reputation on what the vendor's sales guys told you. If the equipment hasn't been designed for that kind of ambient it may well pass the relatively short duration screening test but you will see a sharp reduction in the life of the product. The major stress on integrated circuits, etc., is temperature. As the ambient and component temperatures increase the failure rate increases exponentially and conversely life, and reliability decrease exponentially. Screening the parts by the vendor will only tell you that these particular units made it for an extremely short time (compared to expected product life). How they play with the rest of the system and there associated variables is nothing but a crap shoot, and its going to be a new risk for every lot the vendor produces. The last time I checked the FCC mainly identified the test ambient as between 50F and 100F (but I'm fuzzy on the upper limit), and that the equipment be in a well warmed condition. That implies that the testing done under a normal test site condition would be acceptable. However, I have had a couple of instances when increased temperatures changed, and indeed failed, some equipment. The components and impedances change somewhat, but the problem I encountered was more mechanical in nature. There were some spring tension components that were used for grounding of flex PCB's etc, that expanded under the higher temperatures and they lost there ground contact. I would at least confirm the emissions compliance at the higher temperatures. Gary McInturff
FCC and Hi Temp operation
Hello, everyone. We are integrating a purchased 802.11b device into our product, but face ambient temperature requirements up to 80 degrees C. This brings up two problems: 1. Will it work at that temperature? One vendor advertises 55 degrees max, another 70 but with an offer to "screen" products at 80. 2. What are the FCC requirements? The FCC Rules for the 2.45 GHz band, 15.249, specify a frequency tolerance of 0.001% over the -20 to +50 degree range, but do not specifically address higher temperatures. Do we simply fall back onto the more general provisions of 15.215, keeping the 20dB bandwidth signal within the designated band, with a recommendation to keep it within the central 80% of the permitted range? Since we are not manufacturing the transmitter, which already carries FCC certification, who is responsible to the FCC for ensuring compliance at our extreme temperature? Regards, Chuck Burns Manager of Compliance Cubic Transportation Systems, Inc. 5650 Kearny Mesa Road San Diego, CA 92111 Tel.: (858) 627-4562 Fax: (858) 292-9987 chuck.bu...@cubic.com
Re: Site Atten. and Field Uniformity
Hi Bob, this is something that my lab does. We use network analyzers for NSA, and Field uniformity from 26 MHz to 4 GHz if you need that. While we are not A2LA accredited yet, we hope to be soon. Sincerely, Derek N. Walton Owner L F Research EMC Design and Test Facility Poplar Grove, Illinois, USA www.lfresearch.com
Re: FDA registration of laser
Kim, You DO need to register. Testing may not be required, but is strongly encouraged regardless (technically you can refer to the laser component manufacturer's results). Note: This is assuming that you aren't just putting an off the shelf enclosed CD/DVD ROM drive in a system, which shouldn't require any testing or submission. Best Regards, Dave Heald >>> Kim Boll Jensen 06/11/03 04:54AM >>> Hi all good people Just a simple question. When using a CD or DVD driver in a product (PC or audio product) and the driver is FDA registered, do I need to register the final product at FDA too. I can't find a paragraph in 21 CFR which tells me when not to register. (The drives are Class I but includes a higher laser internally as fare as I know) Best regards, Kim Boll Jensen Bolls Raadgivning Denmark This email has been scanned for computer viruses. This email has been scanned for computer viruses. 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
LED Emissions
I am attempting to measure, in accordance with IEC 60825-1+A1 +A2, the size of the apparent source of a LED plastic fiber optic driver when the fiber is removed. The driver assembly consists of a visible red LED, clear magnifying lens and a barrel into which the 2.2 mm dia plastic fiber cable is inserted up to the lens surface. When I focus a relay lens near the tip of the barrel, I can find a minimal size image that consists of a bright center with concentric rings (reflections along the length of the barrel). The image diameter is about 2.3 mm. When I focus further inside the assembly, I can find a smaller virtual image of the magnified LED surface - about 1 mm diameter. Which of these two images is considered to be the apparent source? If the image near the tip of the barrel is the apparent source, it is a near circular image and I can use a circular aperture to determine the apparent size. If the apparent source is the one inside the barrel, the image is square (the LED die), and the standard appears to say that I must use a rectangular aperture. Is this correct or may I use a circular aperture? If so, the standard does not provide the procedure to determine the apparent size using a rectangular aperture. Any hints? Richard Woods Sensormatic Electronics Tyco International 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
FW: Interconnecting Cables
I didn't receive any comments at all, so I am trying again. Any comments would be welcomed. > -Original Message- > From: WOODS, RICHARD > Sent: Tuesday, June 03, 2003 10:58 AM > To: 'emc-pstc' > Subject: Interconnecting Cables > > I need to determine the robustness requirements for the outer insulation > of an interconnecting cable for ITE when the cable contains hazardous > voltages and when the cable will be in the same physical environment as > the power cord. Clause 1.5.5 of EN 60950:2000 says that the cable must > comply with the relevant requirements of the standard, but those > requirements are not further specified in the standard. One might infer > that the insulation must be no lighter than the requirements for power > cords specified in Clause 3.2.5, but that is not clear. In particular, I > need to determine if properly voltage rated computer interconnect cables > (e.g., UL style 2464) are sufficiently robust to comply with the standard. > Any suggestions on acceptable cable types/styles would be appreciated. > > Richard Woods > Sensormatic Electronics > Tyco International > 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: FDA registration of laser
Kim - If the drive is already certified as a Class 1 laser product and you do not modify it or remove any of the required markings, you don't need to do anything, irrespective of the internal laser source's laser class.Refer to Laser Notice 42 at http://www.fda.gov/cdrh/radhlth/pdf/laser-notice-42.pdf For general information on reporting requirements, refer to http://www.fda.gov/cdrh/radhlth/summary.html and scroll down to or search on Summary of Reporting Requirements or refer to http://www.fda.gov/cdrh/radhlth/eprc_reports_and_records.htm l for more details. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services San Jose, CA peter.tar...@sanmina-sci.com > -Original Message- > From: Kim Boll Jensen > Sent: Wednesday, June 11, 2003 1:55 AM > > Hi all good people > > Just a simple question. > > When using a CD or DVD driver in a product (PC or > audio product) and the > driver is FDA registered, do I need to register > the final product at FDA > too. I can't find a paragraph in 21 CFR which > tells me when not to > register. > > (The drives are Class I but includes a higher > laser internally as fare > as I know) > > > Best regards, > > > Kim Boll Jensen > Bolls Raadgivning > Denmark > 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Home appliances and EN61000-3-2 (harmonics of input current)
Dear colleagues Please, correct me if I am wrong ... After January, 2004, the current amendment A14 to EN61000-3-2 will be imcorporated to the Standard. So, who were Class A will continue to be Class A. Is there any activitie that foresses a new classification of products ? Nowadays, our product is part of home appliances (white goods - more than 75W) that need to comply with Class A. But as happened to TVs and PCs, I think these white goods will be Class D in the future. Thank you ! Günter J. Maass EECON 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: FDA registration of laser
No registration is required if: 1) You put a Class I laser product into your product (in its entirety) and your product is Class I. 2) You include the documentation that came with the laser product with your product. 3) You leave all the labeling on the laser product as you received. There is an official "variance" published by the CDRH that outlines this - I will find dig this up and forward to. Regards, Bill Bisenius ED&D, Inc. bi...@productsafet.com www.productsafeT.com -Original Message- From: Kim Boll Jensen [mailto:k...@bolls.dk] Sent: Wednesday, June 11, 2003 4:55 AM To: EMC-PSTC Subject:FDA registration of laser << File: Kort for Kim Boll Jensen >> Hi all good people Just a simple question. When using a CD or DVD driver in a product (PC or audio product) and the driver is FDA registered, do I need to register the final product at FDA too. I can't find a paragraph in 21 CFR which tells me when not to register. (The drives are Class I but includes a higher laser internally as fare as I know) Best regards, Kim Boll Jensen Bolls Raadgivning Denmark 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: FDA registration of laser
On Wed, 11 Jun 2003 10:54:36 +0200, Kim Boll Jensen wrote: > When using a CD or DVD driver in a product (PC or audio product) and the > driver is FDA registered, do I need to register the final product at FDA > too. I can't find a paragraph in 21 CFR which tells me when not to > register. I would suggest to refer to the Laser Notice No.42 issued from CDRH, at: http://www.fda.gov/cdrh/radhlth/pdf/laser-notice-42.pdf Which is titled "Clarification of compliance requirements for certain manufacturers who incorporate certified Class I laser products into their products", and describes possible reduction of the requirements under certain conditions. Regards, Tom Tomonori Sato URL: http://member.nifty.ne.jp/tsato/ 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Site Atten. and Field Uniformity
I am looking for a company in the US that will perform site attenuation and field uniformity for us. We normally generate our own data but this year we are looking for an independent verification. Bob Heller 3M EMC Laboratory, 76-1-01 St. Paul, MN 55107-1208 Tel: 651- 778-6336 Fax: 651-778-6252 === 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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: New Approach Directives and DOA and DOW
I'm not going to disagree with Neil's approach (indeed I endorse it), but I would observe that the Construction Products Directive (CPD) is different to the other New Approach Directives in this (and many other!) respects, in that CE marking is not possible for products within the scope of the Directive until a Harmonised standard has been published. It is not possible to CE mark against the Essential Requirements of the CPD since these apply to the buildings into which the product is integrated, not the product itself. The European Commission has decided, for all CPD harmonised standards, that there will be a period of 9 months from the Date of Availability of the standard, before CE marking can commence. This is in order to allow governments, trading standards, notified bodies, test labs and manufacturers etc,, to prepare for the big event. Thus even if the Harmonised Standard is available and you can test to it now, you are not permitted to apply the CE marking until after the date published by the Commission in the Official Journal. The CPD is a mess, and certainly has done nothing to promote a free market in construction products for more than ten years now. The Commission has allowed the whole of this market sector to be hijacked by people whose primary business interest is in conformity assessment and as a result manufacturers of CPs will gain nothing like the market freedom offered by (i.a.) the LVD or Machinery Directives. Nick. At 10:13 +0100 11/6/03, Barker, Neil wrote: >I would agree with you. Providing that the CPD has been enacted in the law >of the Member State in which you wish to market your product, and that >appropriate routes to compliance are available, then it should be your >decision to take that route to market in preference to the former national >system. You could take issue with the responsible government agency >concerning the actions of their Notified Body, but remembering that you are >at liberty to use any NB in the EU, I would simply go elsewhere. You don't >have to use a NB in the destination country. > >Best regards, > >Neil R. Barker >Compliance Engineering Manager >e2v technologies ltd >Waterhouse Lane >Chelmsford >Essex >CM1 2QU >U.K. > >Tel: +44 (01245) 453616 >Fax: +44 (01245) 453410 >E-mail: neil.bar...@e2vtechnologies.com > > >> -Original Message- >> From: Kevin Harris [mailto:kevinharr...@dsc.com] >> Sent: 10 June 2003 16:00 >> To: EMC-PSTC (E-mail) >> Subject: New Approach Directives and DOA and DOW >> >> >> >> Hello Group, >> >> I've just been told a story by a notified body under the Construction >> Products Directive in Europe that as far as they were >> concerned, despite the >> fact that a standard was published in the OJ and it's DOA has >> already passed >> that they were under no obligation to accept that standard or >> indeed follow >> the CPD at all until the DOW (removing their national >> standard) had passed. >> In this case, the notified body under the CPD is the same agency that >> currently is their "notified body" under their national system. I have >> always presumed that the choice of systems to follow in the >> transition time >> between DOA and DOW was the manufacturer's and not the >> notified body's. >> Comments? >> >> Best Regards, >> >> >> Kevin Harris >> Manager, Approvals and CAD Services >> Digital Security Controls >> 3301 Langstaff Road >> Concord, Ontario >> CANADA >> L4K 4L2 >> >> Tel: +1 905 760 3000 Ext. 2378 >> Fax +1 905 760 3020 >> >> Email: kevinharr...@dsc.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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: FDA registration of laser
As far as I know, yes, you have to register the actual product with the FDA. That's what I have always done anyway. The fact that the driver is FDA registered will make it a fairly simple paperwork exercise. If you think about it, customs will not be able to associate the driver's FDA accession number with the product it is contained in. The product will need it's own accession number from the FDA (if that makes sense). Regards Chris Colgan Compliance Engineer TAG McLaren Audio Ltd The Summit, Latham Road Huntingdon, Cambs, PE29 6ZU *Tel: +44 (0)1480 415 627 *Fax: +44 (0)1480 52159 * Mailto:chris.col...@tagmclaren.com * http://www.tagmclaren.com > -Original Message- > From: Kim Boll Jensen [SMTP:k...@bolls.dk] > Sent: Wednesday, June 11, 2003 9:55 AM > To: EMC-PSTC > Subject: FDA registration of laser > > Hi all good people > > Just a simple question. > > When using a CD or DVD driver in a product (PC or audio product) and the > driver is FDA registered, do I need to register the final product at FDA > too. I can't find a paragraph in 21 CFR which tells me when not to > register. > > (The drives are Class I but includes a higher laser internally as fare > as I know) > > > Best regards, > > > Kim Boll Jensen > Bolls Raadgivning > Denmark << File: Kort for Kim Boll Jensen >> ** Please visit us at www.tagmclaren.com ** The contents of this E-mail are confidential and for the exclusive use of the intended recipient. If you receive this E-mail in error, please delete it from your system immediately and notify us either by E-mail, telephone or fax. You should not copy, forward or otherwise disclose the content of the E-mail. Important Note: Any typographical, clerical or other error in this communication is subject to correction without any liability on the part of TAG McLaren Audio Limited. Any orders placed shall be subject to acceptance by TAG McLaren Audio Limited on its standard terms and conditions of sale which shall govern the contract for the sale and purchase of the products ordered to the exclusion of any other terms and conditions. TAG McLaren Audio Ltd The Summit, 11 Latham Road Huntingdon, Cambs, PE29 6ZU Telephone : 01480 415600 (+44 1480 415600) Facsimile : 01480 52159 (+44 1480 52159) ** Please visit us at www.tagmclaren.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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: New Approach Directives and DOA and DOW
I would agree with you. Providing that the CPD has been enacted in the law of the Member State in which you wish to market your product, and that appropriate routes to compliance are available, then it should be your decision to take that route to market in preference to the former national system. You could take issue with the responsible government agency concerning the actions of their Notified Body, but remembering that you are at liberty to use any NB in the EU, I would simply go elsewhere. You don't have to use a NB in the destination country. Best regards, Neil R. Barker Compliance Engineering Manager e2v technologies ltd Waterhouse Lane Chelmsford Essex CM1 2QU U.K. Tel: +44 (01245) 453616 Fax: +44 (01245) 453410 E-mail: neil.bar...@e2vtechnologies.com > -Original Message- > From: Kevin Harris [mailto:kevinharr...@dsc.com] > Sent: 10 June 2003 16:00 > To: EMC-PSTC (E-mail) > Subject: New Approach Directives and DOA and DOW > > > > Hello Group, > > I've just been told a story by a notified body under the Construction > Products Directive in Europe that as far as they were > concerned, despite the > fact that a standard was published in the OJ and it's DOA has > already passed > that they were under no obligation to accept that standard or > indeed follow > the CPD at all until the DOW (removing their national > standard) had passed. > In this case, the notified body under the CPD is the same agency that > currently is their "notified body" under their national system. I have > always presumed that the choice of systems to follow in the > transition time > between DOA and DOW was the manufacturer's and not the > notified body's. > Comments? > > Best Regards, > > > Kevin Harris > Manager, Approvals and CAD Services > Digital Security Controls > 3301 Langstaff Road > Concord, Ontario > CANADA > L4K 4L2 > > Tel: +1 905 760 3000 Ext. 2378 > Fax +1 905 760 3020 > > Email: kevinharr...@dsc.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: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
FDA registration of laser
This is a multi-part message in MIME format. Hi all good people Just a simple question. When using a CD or DVD driver in a product (PC or audio product) and the driver is FDA registered, do I need to register the final product at FDA too. I can't find a paragraph in 21 CFR which tells me when not to register. (The drives are Class I but includes a higher laser internally as fare as I know) Best regards, Kim Boll Jensen Bolls Raadgivning Denmark Title: FDA registration of laser Hi all good people Just a simple question. When using a CD or DVD driver in a product (PC or audio product) and the driver is FDA registered, do I need to register the final product at FDA too. I can't find a paragraph in 21 CFR which tells me when not to register. (The drives are Class I but includes a higher laser internally as fare as I know) Best regards, Kim Boll Jensen Bolls Raadgivning Denmark <>
