RE: Blocked ventillation testing
Hi, For rack mounted equipment, UL requires all vent openings be blocked. See 4.5.1 ...Equipment intended for building-in or rack-mounting, or for incorporation in larger equipment, is tested under the most adverse actual or simulated conditions permitted in the installation instructions. If it is not rack mounted, then they are over testing. Ned Devine Entela Inc From: Peter L. Tarver [mailto:peter.tar...@sanmina-sci.com] Sent: Tuesday, November 25, 2003 12:32 PM To: PSTC Cc: Robert Johnson Subject: RE: Blocked ventillation testing Bob - You're quite right that the proposed test constitutes a multiple fault condition and is not supported by any UL standard that I am aware of. I have never had any agency request blocking of all equipment ventilation openings. UL HK should provide you with a rationale for this testing and the issue can certainly be referred to a higher authority within UL if there is disagreement. The only time a more onerous test method should be used is with the agreement of the customer (you or your customer), with the understanding that a noncompliant test result would not necessarily indicate noncompliance with the standard. Regards, Peter L. Tarver, PE Product Safety Manager Homologation Services Sanmina-SCI Corp. 2000 Ringwood Ave. San Jose, CA 95131-1749 V: 408-904-2081 F: 408-904-2095 M: 408-234-3529 peter.tar...@sanmina-sci.com From: Robert Johnson Sent: Tuesday, November 25, 2003 7:56 AM I have been requested by UL-HongKong to the blocked ventillation abnormal testing with all vents on all side blocked simultaneously. My previous experience has been that one side is blocked at a time. Blocking more than one side at a time was considered multiple faults. If it passes blocking all vents at once shortens test time, but is this method necessary? What is the experience of others? Bob Johnson ITE Safety This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ieee-pses.org/ 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 All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ieee-pses.org/ 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 All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: Grounding
Scott, I agree, but why is it not in the standard? Thanks to Bill and Dave, I now know it is in IEC/EN 61010-1 (See IEC/EN61010-1:20001, 6.5.1.1.d.). So, why not in IEC 60950-1 and IEC 60601-1? Ned From: Scott Douglas [mailto:sdoug...@ptcnh.net] Sent: Friday, November 14, 2003 11:43 AM To: Ned Devine; Emc-Pstc Subject: Re: Grounding Ned, I had this discussion with a TUV engineer way back in time. It is not in the UL or IEC standards specifically AFAIK. What the TUV guy asked me to do was consider the life of the product. The door hinge may have good (low) resistance today, but what will it be like in a few years? Hinges naturally get dirty, greasy, corroded over time. They are, by nature, not an air tight construction so dirt and corrosion will get inside. Then the contact points are no longer the low resistance you tested in the development stage. Since there is no standard coverage on this point, all you can do is the due diligence. Either explain it away with sound engineering reasoning (can't be done) or life test it (not practical). In this application, there is no common metal that will not corrode or oxidize when exposed to air and moisture, and no coating that will not wear through over time thus exposing those metals that will corrode or oxidize. And the fix is relatively painless, 6 inches of green yellow wire, two ring lugs, two lock washers and two nuts (or KEPS nuts with lock washers built in). The hard part is the two PEM studs, one in the door and one in the chassis. I think the key here is the air tight connection of the door and the chassis to provide a reliable PE connection. BTW, since the hinge is a moving part, most hinges will move around to a point where the resistance will change dramatically, depending on hinge quality and age. Oh, and watch out for hinge mounting. We had a piano hinge mounted on a cover, but only after they painted the cover with no masking done! Good luck. Scott Ned Devine wrote: Hi, I need some help. I told someone that you can not depend on mechanical contact only (i.e. in this case a door hinge) for protective earth. Even if it passes the test, it would still not be acceptable because it does not meet the construction requirements. He then asked me to show him were it said that in the standard (IEC 60950-1 or IEC 60601-1). I looked and could not find it. Am I just missing it, or is it not in the standards? There is a reference in CSA standards to C22.2 No. 0.4 that has the requirement, but I can not find a similar reference in UL or IEC standards. Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com 1-800-888-3787 Web: www.entela.com Grand Rapids * Detroit * Boston * Toronto * Taipei This message is confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. --- 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 confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site
Grounding
Hi, I need some help. I told someone that you can not depend on mechanical contact only (i.e. in this case a door hinge) for protective earth. Even if it passes the test, it would still not be acceptable because it does not meet the construction requirements. He then asked me to show him were it said that in the standard (IEC 60950-1 or IEC 60601-1). I looked and could not find it. Am I just missing it, or is it not in the standards? There is a reference in CSA standards to C22.2 No. 0.4 that has the requirement, but I can not find a similar reference in UL or IEC standards. Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com 1-800-888-3787 Web: www.entela.com Grand Rapids * Detroit * Boston * Toronto * Taipei This message is confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. 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
EMC Position
Hi, A headhunter contacted me about this position. If interested, please contact Stratos at sdal...@prausa.com Ned Devine Entela Inc Are you an EMC engineer looking for a company that will truly appreciate your skills? Do you want to work on next generation products you'll see on the road for years to come? Our client, a Tier One manufacturer of advanced automotive electronic products, is looking for an EMC Project Engineer to join their safety systems team. In this position, you will work directly with development teams to provide direction on design for EMC issues at the PCB and system level. From there, you will lead and perform EMC design, develop EMC test plans, design related test equipment, and perform EMC tests. Testing will revolve around product specifications, domestic and international regulatory standards, and customer requirements. You will analyze results, perform problem diagnosis, and recommend solutions. This is a long term position with a company interested in developing your skills over the years to come. They have been experiencing growth while other companies have been struggling to get by. In addition, your work on these products will help create safer cars of the future. Qualified candidates will have a BSEE (MSEE preferred) and 3+ years of engineering experience. At least 3 years must have been spent in design and testing for EMC compliance. You must also have experience in PCB layout, grounding, troubleshooting problems related to ESD immunity, RF emissions, RF test equipment, and power line anomalies. An automotive background is preferred and knowledge of antennas and electromagnetics is required. You will be working directly with engineers in other departments, so excellent communication skills are a must. This position is in Farmington Hills, MI. Relocation is available. This message is confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. 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
NARTE's Product Safety Certification
FYI I just received notice of NARTE’s Product Safety Certification program. For details, see www.narte.org http://www.narte.org/ Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com This message is confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you.
RE: centrifuges and the MDD
Paul, If the centrifuge is used for blood, then it is covered under the MDD. It is classified under Rule 3 and is a Class IIa device. See the MEDDEV Guidelines for the Classification of Medical Device. Centrifugation of blood to prepare it for transfusion or autotransfusion. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com From: Smith, Paul J. [mailto:paul.j.sm...@thermo.com] Sent: Tuesday, October 14, 2003 5:11 PM To: emc-p...@ieee.org Subject: centrifuges and the MDD List Members, There is persistent question on whether centrifuges are covered under the MDD or LVD. Can anyone point to any info that specifically calls out centrifuges as product covered under the MDD? I have found only a very vague description of covered products but nothing that conclusively includes centrifuges as a product covered under the Medical Device Directive. Best Regards, Paul J. Smith Standards Engineer 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 confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. 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: IE C60601-1 table 16
Brian, If I understand you question, you are correct. IEC 60601-1 second edition does not address any voltages other than rms and DC. The draft third edition does address peaks. It is up to you and if applicable the test house, how to interpret what the rms value is. NOTE: you can interpolate. See recommendation 27. If you should have any questions or comments, please feel free to contact me. Sincerely, Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com Entela, Inc. A Certified Woman Owned Business From: Brian O'Connell [mailto:boconn...@t-yuden.com] Sent: Thursday, August 14, 2003 10:01 AM To: 'emc-p...@majordomo.ieee.org' Subject: RE: IE C60601-1 table 16 Sir Thanks for your reply. What clause in 601-1 provides this definition determination of WV? I have already discerned what insulation class is being referred to, and which insulation class is required, as 601-1 clearly explains and diagrams (at least) this... Am I blind or is there no clause that defines WV (referred to as reference V in the standard) and if peak V shall be considered? thanks very much for everyone's advice. Brian -Original Message- From: FastWave [mailto:bi...@fastwave.com] Sent: Thursday, August 14, 2003 5:17 AM To: 'Brian O'Connell'; 'emc-p...@majordomo.ieee.org' Subject: RE: IE C60601-1 table 16 Brian, Working voltage is determined in the same manner as 950, 1010, etc. A special consideration is that you may have to consider the possibility of any patient connection being earthed. Table 16: The first row titled equivalent to Basic insulation between parts of opposite polarity is what 950 refers to as Operational insulation in the mains circuit = insulation that may protect from a Risk of Fire but not does not provide Risk of Shock protection. The second row is for Basic Supplementary insulation. And the third row is for Double Reinforced insulation. Each row is split to provide the creepage the clearance requirement for each working voltage column. The weird letters in the second column (A-f, A-a1, etc.) relate to Appendix E in the back of the standard. Appendix E has diagrams showing what constitutes operational, basic, supplementary, reinforced, double insulation. So if you are unsure if a particular creepage/clearance distance is considered o/b/s/r/d, you can use Appendix E. Just remember that the 601 standards do not use the term operational insulation. Regards, Bill Bisenius E.D. D. bi...@productsafet.com www.productsafeT.com -Original Message- From: Brian O'Connell [mailto:boconn...@t-yuden.com] Sent: Wednesday, August 13, 2003 6:00 PM To: 'emc-p...@majordomo.ieee.org' Subject: IE C60601-1 table 16 Good People Would someone please provide relevant clause that explains how to use this table. Are the peak/dc and rms WV used seperately to determine clearance creepage, as in 60950? or is the greater of the dc or ac WV used to determine both crp clr ? Is the same measurement technique for determining WV as in 60950, 1010-1, etc ? thanks much Brian 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
Product Safety Engineer
Hi, We are looking for an experience Product Safety Engineer. They should have at least 5 years experience in testing Medical Equipment (IEC/CSA/UL 601 series). The Engineer will be stationed in our Boston office. We also have locations in Toronto and Grand Rapids, MI and would consider locating the engineer in one of these offices. Entela is an OSHA approved NRTL; accredited by the SCC, for electrical product safety; and a participating National Certification Body (NCB) within the IECEE/CB scheme. If you are interested, or would like more information, please contact me. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com Entela, Inc. A Certified Woman Owned Business 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
Thermocouple glue
Hi, In the past I have used Henkel Sicomet 77 to adhere thermocouples. I just tried to reorder some and was told it has been discontinued. Does anyone have a recommendation on a replacement? Thanks Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com Entela, Inc. A Certified Woman Owned Business 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 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: Is Authorised Representative in EU Required?
Hi, Yes it is required for some of the directives. For the MDD, the requirement is in Article 14, paragraph 2. For the IVDD it is in Article 10, paragraph 3. If you should have any questions or comments, please feel free to contact me. Sincerely, Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com Entela, Inc. A Certified Woman Owned Business From: Joe P Martin [mailto:marti...@appliedbiosystems.com] Sent: Tuesday, March 25, 2003 8:31 PM To: emc-p...@majordomo.ieee.org Subject: Is Authorised Representative in EU Required? Greetings, In order to meet the requirements of European Union Directives, if the manufacturer is not established in the Community, is it required to have an Authorised Representative established in the Community? Is the requirement, or non-requirement, the same for all Directives? I am mostly concerned with In-Vitro Diagnostics, EMC, Low Voltage, Machinery and Medical Directives. If you have available, please provide specific Article(s) where this is specified in the Directives or the Directive Guidelines. As always, your responses are greatly 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: davehe...@attbi.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: davehe...@attbi.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: mouse heart monitor
Hi, I vote for LVD and IEC 61010-1. The definition of a medical device in the MDD and IVD includes ... intended by the manufacturer to be used for human beings for the purpose of... So, the MDD and IVD don't apply. In IEC 60601-1, the definition of Patient (Clause 2.12.4) does include animals. But, the definition for Medical Electrical Equipment (Clause 2.2.15) states ...intended to diagnose, treat, or monitor the Patient under medical supervision So, from the purpose that you described, I don't think IEC 60601-1 is the correct standard. IEC 61010-1:2001, does not limit its scope to humans. The scope for electrical laboratory equipment includes ...measures, indicates, monitors or analyses substances, or is used to prepare materials, This sounds like the purpose of your device. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com Entela, Inc. A Certified Woman Owned Business From: Sam Davis [mailto:sda...@ptitest.com] Sent: Wednesday, February 05, 2003 5:01 PM To: emc-p...@majordomo.ieee.org Subject: mouse heart monitor All, I'm trying to work up a quote for testing a product which monitors various heart functions of living laboratory mice. Would this fall into the Medical Directive under 60601, or the LVD, under 61010? I'm just looking at the safety aspects, not EMC. The question comes up because the definition of patient in 601 (old version at least) includes human or animal. This is not veterinary equipment (save the mouse's life), but laboratory equipment (use the mouse's life to learn how to save human's lives). Thanks, Sam 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 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: davehe...@attbi.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: CE marking software product
Hi,
What is the software for? It is possible that it will fall under the
Medical Device Directive or IVDD (and FDA) if it is used in the medical
field.
If you should have any questions or comments, please feel free to contact
me.
Sincerely,
Ned Devine
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI 49548
Phone: 616 248 9671
Fax: 616 574 9752
e-mail: ndev...@entela.com
www.entela.com
Entela, Inc. A Certified Woman Owned Business
-Original Message-
From: iun...@servomex.com [mailto:iun...@servomex.com]
Sent: Tuesday, December 10, 2002 8:35 AM
To: emc-p...@majordomo.ieee.org
Subject: CE marking software product
Dear Group,
We wish to market a product consisting of a CD rom+ software, serial cable
and RS232 Interface Converter ('bought in' component and CE marked).
Are there any CE marking requirements for this type of product? If so,
which directives do they come under?
Many thanks
Ian Unwin
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RE: Medical Devices Environmental Requirements
Hi, In the USA the FDA has a guidance document that some of the branch's (i.e. Anesthesiology and Respiratory) use. See http://www.fda.gov/cdrh/ode/638.pdf This includes both EMI, and mechanical and environmental requirements. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: ndev...@entela.com www.entela.com Entela, Inc. A Certified Woman Owned Business -Original Message- From: Mandel, Joel [mailto:joel_man...@adc.com] Sent: Tuesday, November 05, 2002 11:43 AM To: 'emc-p...@majordomo.ieee.org' Subject: Medical Devices Environmental Requirements Hi All Can anybody help me out with Environmental testing requirement/Standards (Temp,Vibration) for medical devices? Thank You Joel Mandel Reliability Dept ADC Israel --- 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 --- 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: medical-grade transformers
Hi, From Appendix A, General Guidance and Rationale, for Clause 57.9 ...For reasons of PATIENT safety additional requirements must be applied to the construction of such transformers, e.g. restriction of LEAKAGE CURRENTS flowing to PATIENT CIRCUITS. 57.9.4 e) In transformers with REINFORCED INSULATION or DOUBLE INSULATION the insulation between the primary and secondary winding shall consist of: - one insulation layer having a thickness of at least 1 mm, or - at least two insulation layers with a total thickness of not less than 0.3 mm, or - three layers provided that each combination of two layers can withstand the dielectric strength test for REINFORCED INSULATION. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com -Original Message- From: Dean Gerard (gdean) [mailto:gd...@ncht.trent.nhs.uk] Sent: Monday, July 29, 2002 9:29 AM To: 'emc-p...@majordomo.ieee.org' Subject: medical-grade transformers With regard to transformer construction, CLAUSE-57.9.4(e) of EN-60601-1 General Requirements for Safety of Medical Electrical Equipment requires:- In transformers with REINFORCED INSULATION or DOUBLE INSULATION the insulation between 1ary and 2ary windings shalll consist of - - 1 insulation layer having thickness at least 1mm, or - at least 2 insulation layers with total thickness not less than 0.3mm, or - 3 layers provided each combination of 2 layers can withstand the dielectric strenght test for REINFORCED INSULATION Can anyone explain ther rationale behind these requirements ? Thanks. Ged Dean Nottingham City Hospital. ** This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the system manager. This footnote also confirms that this email message has been swept by MIMEsweeper for the presence of computer viruses. NCHT ** --- 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 --- 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
Job Position
Hi, Got this from a headhunter. The job is in Pennsylvania. If interested, please contact him directly. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com JOB OPPORTUNITY-COMPLIANCE ENGINEER.doc JOB OPPORTUNITY-COMPLIANCE ENGINEER.doc Description: MS-Word document
RE: UL 1244
Hi, I pulled the bulleting for UL 1244. The phase out dates are. ESTABLISHED EFFECTIVE DATES Implementation will be in accordance with the following schedule: Now until December 31, 2002- Manufacturers may submit to either UL 1244 or UL 3111-1 requirements. Equipment that is evaluated to UL 3111-1 will also be evaluated to any applicable Particular Standards. January 1,2003 to December 31, 2007 - Manufacturers of new equipment must submit to UL 3111-1 plus applicable Particular Standards; however, equipment previously manufactured and evaluated under UL 1244 will continue to be Listed (or Recognized) until December 31,2007 unless changes are made to the equipment in which case the equipment must be evaluated to UL 3111-1. After January 1, 2008 All equipment must be evaluated to UL 3111-1 and any applicable Particular Standards which apply to the specific type of equipment. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com -Original Message- From: Brooks, Barbara [mailto:bbro...@hnt.wylelabs.com] Sent: Thursday, May 23, 2002 9:19 AM To: EMC Post Subject: UL 1244 Members, I have been told that UL 1244 will be withdrawn in the near future. Does anyone have the date this standard will be withdrawn? Thank you for your assistance. Barbara Brooks Wyle Laboratories 7800 Highway 20 West Huntsville, AL 35807- (256) 837-4411 ext 595 (253) 721-0144 Fax bbro...@hnt.wylelabs.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...@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 --- 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: Constant for Change of Resistance formula.
Hi, Thanks to all who responded. This seems to be the answer I was looking for. Time to get out the physics book and do a little research. Ned Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com -Original Message- From: Colgan, Chris [mailto:chris.col...@tagmclaren.com] Sent: Monday, May 13, 2002 5:28 AM To: emc-p...@majordomo.ieee.org Subject: RE: Constant for Change of Resistance formula. Ned is referring to the constant used in the temperature rise calculated by change in resistance formula ie ... Where dt is the temperature rise, R1 is start resistance, R2 is end resistance, T1 is start ambient and T2 is end ambient. 234.5 is the formula constant for copper. This formula is used extensively when heat testing transformers and coils. I'm afraid I don't know the constant for brass but I believe the figure may be related to the inferred absolute zero of a material. Try asking a metallurgist? 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: Robert Wilson [SMTP:robert_wil...@tirsys.com] Sent: Friday, May 10, 2002 7:00 PM To: emc-p...@majordomo.ieee.org; Ned Devine Subject: RE: Constant for Change of Resistance formula. What are the units? 234.5 ...what?? Looking at what the units are, will basically tell you exactly what the property is related to. Nonetheless, you cannot possibly directly determine what the temperature change of something as physically and geometrically complex as a connector, merely by factoring in what its resistance change is. Among other things, the solution is extremely non-linear and iterative. Changing resistance will generate more heat, which will increase temperature, which will generate even more heat and on and on! Add this to the fact the resistance coefficient with temperature is itself non-linear, and you can see how this complicates things further. The final temperature that the system stabilizes at, is reached when the logarithmically increasing (i.e. also very non-linear) heat transfer to the environment caused by increasing temperature, balances increased heat being generated. To reach a solution, you need to iterate your calculations, where the results of one calculation are plugged as variables into the next iteration. Typically a thermal analysis program will require several hundred iteration before a converged solution results. Bob Wilson TIR Systems Ltd. Vancouver. -Original Message- From: Ned Devine [mailto:ndev...@entela.com] Sent: May 10, 2002 8:29 AM To: emc-p...@majordomo.ieee.org Subject: Constant for Change of Resistance formula. Hi, Does any one know how the constant for CoR formula was determined? I know the K is 234.5 for copper and 226 for aluminum, but what property is this related to? I am trying to determine the change in temperature of a connector, based on the change of resistance. The connector contacts are made of brass. Thanks Ned Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com ** 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. 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: davehe...@attbi.com For policy questions, send
Constant for Change of Resistance formula.
Hi, Does any one know how the constant for CoR formula was determined? I know the K is 234.5 for copper and 226 for aluminum, but what property is this related to? I am trying to determine the change in temperature of a connector, based on the change of resistance. The connector contacts are made of brass. Thanks Ned Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com
RE: UL 61010A-1
Hi, I did a quick search on the UL web page. There is a STP (Standards Technical Panel) project for UL 61010A-1. See http://ulstandardsinfonet.ul.com/stp/active-stps.html. There are contact names there. It doesn't specify exactly what it is, but my guess is that it is for the adoption of IEC 61010-1, Second Edition. I also noted references to UL 61010B-1 and UL 61010C-1. I am assuming that UL is splitting out laboratory, control and measuring equipment into three standards. Ned Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com -Original Message- From: marti...@appliedbiosystems.com [mailto:marti...@appliedbiosystems.com] Sent: Tuesday, May 07, 2002 7:19 PM To: emc-p...@majordomo.ieee.org Subject: UL 61010A-1 Greetings, I recently heard that UL released UL 61010A-1 which is their version of EN 61010-1. It is my understanding that this standard will replace UL 3101-1. Does anyone know if the UL version is identical to EN 61010-1: 2001? What is the status for the withdrawal of UL 3101-1? All responses are appreciated. Regards Joe Martin EMC/Product Safety Engineer 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: 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 --- 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: Re[2]: Thermal Testing
Hi, We have 6 of the systems. We use them not only for temperature measurement, but data logging for fixtures we build. The only complaint is that you can not control more that one unit using the BenchLink software. You can use the HP-IP bus to control more than one, but then you need to write software. We have also had a problem with data dropping (1 or 2 readings out of a scan), but only at high speed and to a notebook PC. We assumed it was a function of the RS-232 bus. Ned Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com -Original Message- From: richwo...@tycoint.com [mailto:richwo...@tycoint.com] Sent: Tuesday, May 07, 2002 12:39 PM To: emc-p...@majordomo.ieee.org Subject: RE: Re[2]: Thermal Testing This almost appears to be too good to be true. Let's see if I have this right. 34970A Data Acquisition/Switch Unit with software, $1290 34901A 20 Channel Mux, $395 34307A Thermocouple kit with 10 thermocouples, $98 Total for a 20 channel thermocouple system is $1881. That's cheap! OK, what is wrong with this picture (if anything)? Anyone have anything negative to say about this system? Richard Woods Sensormatic Electronics Tyco International -Original Message- From: Michael Taylor [mailto:mtay...@hach.com] Sent: Tuesday, May 07, 2002 10:23 AM To: 'duncan.ho...@snellwilcox.com'; EMC-PSTC Discussion Group; richwo...@tycoint.com Subject: RE: Re[2]: Thermal Testing We also use the 34970A for data acquisition with HP BenchLink for our safety testing and are very pleased with it's performance and ease of use. We also have a Hydra II system which mostly gathers dust now. The 34970 / BenchLink system is so much easier to setup use. Also the data log is a snap to link into a Word report. For what it's worth. Michael Taylor Colorado -Original Message- From: duncan.ho...@snellwilcox.com [mailto:duncan.ho...@snellwilcox.com] Sent: Tuesday, May 07, 2002 2:46 AM To: EMC-PSTC Discussion Group; richwo...@tycoint.com Subject: Re[2]: Thermal Testing Richard, We use an Agilent 34970A data aquisition unit with three 34901A 20 channel mux modules fitted. This is not a PC card but a rack and stack instrument about the size of a bench DVM that connects to the PC via a serial cable. It also comes with the software. Very similar to the fluke hydra II. This has proven to be an excellent instrument and well worth the investment. Most other equipment of the same price could only offer around 10 channels of measurement whereas this allows up to 60. It is also modular so you only need buy as many 20 channel mux modules as you need. Regards, Duncan Reply Separator Subject: Re: Thermal Testing Author: Doug McKean mailto:dmck...@corp.auspex.com List-Post: emc-pstc@listserv.ieee.org Date: 5/6/2002 22:11 richwo...@tycoint.com mailto:richwo...@tycoint.com wrote: Do any of you monitor and record component temperatures during safety testing using PCs and data capture I/O cards? If so, what hardware and software to you use? I do any monitoring any temp testing with a Fluke Hydra II and associated PC software. Set up and define probes, start software, dump into an Excel spreadsheet or report. Communication between the Fluke and the PC is done through serial ports. - 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...@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: IEC 60601-2-24 / Magnetic Field
Hi, Yes. Triple checked. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com -Original Message- From: plaw...@west.net [mailto:plaw...@west.net] Sent: Thursday, May 02, 2002 11:24 AM To: EMC-PSTC Subject: Re: IEC 60601-2-24 / Magnetic Field Are you sure about the IEC 60521 reference? IEC 60521 (1988-03) Class 0.5, 1 and 2 alternating-current watthour meters Applies only to newly manufactured induction type watt-hour meters of accuracy classes 0.5, 1 and 2, for the measurement of alternating current electrical active energy of a frequency in the range 45 Hz to 65 Hz and to their type tests only. This publication supersedes IEC 60043 (1960), 60170 (1964) and 60280 (1968). Patrick Lawler plaw...@west.net On Mon, 29 Apr 2002 10:55:57 -0400, Ned Devine ndev...@entela.com wrote: I can help much, but, for this paragraph, the rationale at the back of the standard states that Annex AAA of the Collateral Standard IEC 60601-1-2 states that the limits and methodology are under consideration by technical committee 77. This Particular Standard, however, refers for the time being to IEC 60521 in which 400 A/m is required. For the Second Edition of IEC 60601-1-2, Clause 36.202.8.1, the limit is 3 A/m. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com -Original Message- From: am...@westin-emission.no [mailto:am...@westin-emission.no] Sent: Sunday, April 28, 2002 3:40 PM To: emc-p...@majordomo.ieee.org Subject: IEC 60601-2-24 / Magnetic Field Hi all, A colleague was checking the IEC 60601-2-24:98 and found the Magnetic Field Req't (paragraph 36.202.6) far too high: 400 Ampere-per-meter! I'd like to check this requirement for its correctness or history with backgrounds for such a demand. I know that 3A/m, 10A/m and 30A/m are often used, but 400A/m . Can anybody help? Best regards Amund Westin, Oslo/Norway PS: IEC 60601-2-24:98 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers --- 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 --- 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: IEC 60601-2-24 / Magnetic Field
Hi, I can help much, but, for this paragraph, the rationale at the back of the standard states that Annex AAA of the Collateral Standard IEC 60601-1-2 states that the limits and methodology are under consideration by technical committee 77. This Particular Standard, however, refers for the time being to IEC 60521 in which 400 A/m is required. For the Second Edition of IEC 60601-1-2, Clause 36.202.8.1, the limit is 3 A/m. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail Entela, Inc. A Certified Woman Owned Business www.entela.com -Original Message- From: am...@westin-emission.no [mailto:am...@westin-emission.no] Sent: Sunday, April 28, 2002 3:40 PM To: emc-p...@majordomo.ieee.org Subject: IEC 60601-2-24 / Magnetic Field Hi all, A colleague was checking the IEC 60601-2-24:98 and found the Magnetic Field Req't (paragraph 36.202.6) far too high: 400 Ampere-per-meter! I'd like to check this requirement for its correctness or history with backgrounds for such a demand. I know that 3A/m, 10A/m and 30A/m are often used, but 400A/m . Can anybody help? Best regards Amund Westin, Oslo/Norway PS: IEC 60601-2-24:98 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers --- 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 --- 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: Safety Certs - custom lamps
Hi, He needs Field Evaluation. The investigation and cost is based on an unit price. Have him contact me. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: George Stults [mailto:george.stu...@watchguard.com] Sent: Thursday, March 28, 2002 1:27 PM To: 'emc-p...@majordomo.ieee.org' Subject: Safety Certs - custom lamps Hello Group, I am forwarding this question for a colleague who resides in Washington state, USA. Basically he would like to create, on a commercial basis, custom lighting (lamp fixtures), both portable (carry and plug in) , and permanent (built into a house). However, building inspectors etc want to see a safety mark for these creations. (UL or CSA or NRTL etc.) He is looking for advice about how a small business can economically and efficiently achieve safety certification for one-of-a-kind custom lighting fixtures. Thanks in advance George Stults --- 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 --- 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: UL1492
Hi, I pulled UL 1492. 127.4.2 A product that is capable of emitting ionizing radiation or that contains a laser diode shall have a distinctive marking to identify the full name and address of the manufacturer. If the product is to be sold under a name other than the manufacturer, the full name and address of the organization responsible for the product may be used. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Peter Tarver [mailto:peter.tar...@sanmina-sci.com] Sent: Monday, February 11, 2002 11:37 AM To: emc-p...@majordomo.ieee.org Cc: Andrew Carson; richwo...@tycoint.com Subject: RE: UL1492 Richard - If the monitor contains a CRT, the requirement in question may arise from 21CFR, rather than UL. The responsible company needs their name and address marked on products. Regards, Peter L. Tarver, PE Product Safety Manager Sanmina-SCI Homologation Services peter.tar...@sanmina-sci.com -Original Message- From: Andrew Carson Sent: Monday, February 11, 2002 2:41 AM Richard The only people for certain who know what should be on a label are UL, so a quick phone call to your local office should help. But we OEM manufacture raid systems and have never had a problem with only placing the File number on the label. The file numbers are public domain information and anyone can obtain a manufacturers name and address from it. Also I have evaluated many products badged by one company, but the file number tells me they were made by someone else. So does not seem right from my past experience. richwo...@tycoint.com wrote: An OEM of video monitors has obtained UL Listing under UL 1492. They tell us that the address of our company must appear on the rating label. Is that correct? 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: 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
IEC 60601-1-2 Second Edition
Hi, I need some help from the EMC experts. According to FDA Acting Chief of the Brach I am dealing with, since the FDA has recognized IEC 60601-1-2 Second Edition (October 2001), then ...If they submit a new 510(k) (or even a modification for an existing device) and we have recognized the more recent standard, then they would need to comply with the new standard. Making the new edition immediately effective seems a little harsh. I am appealing his interpretation, but I don't know if I will have any luck. Has anyone had any success in doing a risk analysis to use lower immunity compliance levels than specified in IEC 60601-1-2, Second Edition, Section 36.202.1 a) or using different compliance criteria (36.202.1 j))? Or does Clause 6.8.3.201 a) 5), These justification shall be based only on physical, technological or physiological limitations... pretty much preclude the use of lower limits? The device in question meets IEC 60601-1-2 First Edition, but will not pass the requirements in the Second Edition. Can the justification be that since there are no known risks on the device, the current level of immunity is adequate? Thanks Ned Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 1 616 248 9671 Phone 1 616 574 9752 Fax ndev...@entela.com e-mail --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server.
RE: Hearing aids
Nick, The FDA classification for hearing aids, air-conduction, are at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?I D=943 They are Class I, Exempt devices. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Nick Williams [mailto:nick.willi...@conformance.co.uk] Sent: Thursday, January 31, 2002 10:47 AM To: emc-p...@majordomo.ieee.org Subject: Hearing aids Can anyone quickly and easily point me at any FCC/FDA requirements for hearing aids? Thanks in anticipation. Regards Nick. --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server. --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server.
RE: ICE 601-1 : Insulation between applied part and signal input
Hi, The requirements for insulation between the Applied Part, F-type and the Signal Input part is defined in clause 20.2, part B-d. You need Basic insulation. The working voltage is at a minimum the rated supply voltage. See clause 20.3, paragraph 6. So, assuming 230 Vac input. The requirements are Basic Insulation, Dielectric is 1,500 Vac. Creepage is 4.0 mm, Air Clearance is 2.5 mm. You can use anything the meets these requirements. See also Clause 17.a) for separation requirements. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Pierre SELVA [mailto:pierre.se...@worldonline.fr] Sent: Thursday, December 27, 2001 4:25 PM To: Forum Safety-emc Subject: IEC 601-1 : Insulation between applied part and signal input Hello from the Franch Alps, I need your help to determinate which insulation is required between an applied part (lin to the OV of the product thru a capacitor) and one signal input in a medical product, against IEC 601-1 requirements. The signal input is connected to the parallel port of a computer. I understand that the insulation has to be a supplementary one. Does this mean that I need to have a galvanic insulation (with optocoupleur, for example) or can I use another system ? Thanks a lot for your contribution. Bonnes fêtes de fin d'année et meilleurs voeux pour 2002 (happy new year and best whishes !) eLABs Pierre SELVA 18 Rue Marceau Leyssieux 38400 SAINT MARTIN D'HERES - FRANCE Phone : 33 (0)6 76 63 02 58 Fax : 33 (0)6 61 37 87 48 e-mail : e.l...@wanadoo.fr mailto:e.l...@wanadoo.fr ps.el...@laposte.net mailto:ps.el...@laposte.net ==
RE: FDA
Hi, In the USA, it is the FDA. For most medical products, the FDA determines that your product is Substantially Equivalent to a legally marketed device. This is the FDA 510(k) process. They issue you a letter that allows you to legally market the device. For EMC, the FDA usually wants to see that you comply with IEC 60601-1-2. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: am...@westin-emission.no [mailto:am...@westin-emission.no] Sent: Friday, October 26, 2001 5:15 AM To: emc-p...@majordomo.ieee.org Subject: FDA Hi all, What is the basic differences between FDA and FCC ? Don't laugh, yes I know it is a silly question, but if you want to certify medical equipment, are the requirements covered in the FDA or in the FCC regulations ? As you understand, within this field, I'm a really novice ... Best regards Amund Westin, Oslo/Norway --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server. --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server.
RE: Medical application-Isolation voltage
Peter, Be careful, some agencies have taken the 1.0 mm thickness requirement for transformers (57.9.4.e, first dash) and applied it to potted components the need reinforced insulation. IEC 60950, I believe only requires 0.4 mm for reinforced. Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Peter Merguerian [mailto:pmerguer...@itl.co.il] Sent: Friday, August 31, 2001 3:38 AM To: 'Ned Devine'; emc-p...@majordomo.ieee.org Subject: RE: Medical application-Isolation voltage Ned, I agree with you except for one point. Most ac/dc convertors are encapsulated. Therefore no internal claearances or creepages. Most likely the external clearance/creepage of 5.0/8.0mm betwen the primary and secondary pins will be met. The IEC 601/UL2601-1 does not have a requirement for oven aging of the potting as in IEC950/UL60950. As such, I would have to say that a 950 ac/dc convertor could pass as long as it meets the stricter leakage current and dielectric strength requirements of the IEC601-1/UL2601-1 standard. One final comment. Check the UL Conditions of Acceptability for the ac/dc converor and the TUV or VDE license. Most of these convertors specify that the abnormals were tested with a specific type fuse at the input and if any other fuse is used in the end-product, it will be necesary to repeat the abnormal tests. It is very important to use the correct or better fuse characteristics in order to reduce the amount of testing required in the end-product (ie if the convertor manufacturer is willing to share their schematics and providing upotted samples to conduct the tests!). PETER S. MERGUERIAN Technical Director I.T.L. (Product Testing) Ltd. 26 Hacharoshet St., POB 211 Or Yehuda 60251, Israel Tel: + 972-(0)3-5339022 Fax: + 972-(0)3-5339019 Mobile: + 972-(0)54-838175 -Original Message- From: Ned Devine [mailto:ndev...@entela.com] Sent: Thursday, August 30, 2001 3:31 PM To: emc-p...@majordomo.ieee.org Subject: RE: Medical application-Isolation voltage Hi, The voltages in IEC 60601-1 are rms. See paragraph 20.4.b. You need a converter that is certified for medical. Not only is the dielectric higher, but the spacing (8mm CD, 5mm AC) are higher. Most power supplies designed for IEC 60950 will not pass. Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: John Woodgate [mailto:j...@jmwa.demon.co.uk] Sent: Wednesday, August 29, 2001 3:18 PM To: emc-p...@majordomo.ieee.org Subject: Re: Medical application-Isolation voltage I read in !emc-pstc that Ron r...@vascor.com wrote (in 00d501c1309e$f4 81d540$21df7...@vascor.com) about 'Medical application-Isolation voltage', on Wed, 29 Aug 2001: I have a medical application that requires double insulation from the Mains to an applied part according to IEC60601. IEC60601 states that for a reference voltage of 250v and double insulation, the test voltage is 4000v for 1 min. I am assuming that the voltages are RMS values. Yes, unless another measure is specified. Look carefully: it may be a peak value. How does one go about meeting the 4000v test when the highest rated ac-dc converter I can find is 3500v RMS continuous. Complain to the converter manufacturers that you can't buy their product because it doesn't meet the standard. It's their problem, not yours! -- Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk Eat mink and be dreary! --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server. --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard
RE: Susceptibility level of medical devices (incubator) - urgent!
Hi, Per the FDA guidance on EMC http://www.fda.gov/cdrh/ode/638.pdf The limit is 3 V/m. See the page numbered 25 of the document. Note: This is for general medical equipment! There is a guidance document for incubators http://www.fda.gov/cdrh/ode/incubator.html It references IEC 60601-2-19 and 2-20. 2-19 and 2-20 both require the unit to pass at 3 V/m and to pass or fail safe at 10 V/m. Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Ralph Cameron [mailto:ral...@igs.net] Sent: Monday, August 27, 2001 5:33 PM To: Antonio Sarolic; emc-p...@majordomo.ieee.org Subject: Re: Susceptibility level of medical devices (incubator) - urgent! Antonio: I would say many incubators were manufactured when there were no concerns and the susceptibility was a function of the design and very variable. I have heard they vary from 0.1V/m to 10V/m but don't think there is any set standard. The medical gurus prefer to isolate their equipment by physical barriers and hope that something will not affect them In Canada Health Canada could answer thequestion . In the U.S. I believe its the Food and Drug Administration. Ralph Cameron EMC Consulting and Suppression of Consumer Electronics (After sale). - Original Message - From: Antonio Sarolic antonio.saro...@fer.hr To: emc-p...@majordomo.ieee.org Sent: Monday, August 27, 2001 11:59 AM Subject: Susceptibility level of medical devices (incubator) - urgent! Hi I need urgent info on susceptibility level of medical electronic devices, especially baby incubators. Can anyone confirm if it is 1V/m (according to EU standards)? The EMI source is the GSM BS antenna (900MHz). Thanks very much. Antonio Antonio Sarolic, M.S.E.E. Faculty of Electrical Engineering and Computing Dept. of Radiocommunications and Microwave Engineering Unska 3, HR-1 Zagreb, CROATIA tel. +385 1 61 29 789, fax. +385 1 61 29 717 E-mail: antonio.saro...@fer.hr --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server. --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server. --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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: No longer online until our new server is brought online and the old messages are imported into the new server.
EMC, Safety and Telecom Approval for a Modem
Hi, I need some help. I have a medical device that has a modem. The medical device I can handle. What I need some help in is establishing the requirements (testing and certification for EMC, Safety and Telecom) for the modem. The target countries are: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, The Netherlands, New Zealand, Philippines, Poland, Singapore, South Africa, Spain, Switzerland, United Kingdom, United States, Finland, Norway and Sweden. (don't you just love the marketing guys :-) I know this is a lot of information, so I am expecting to pay for it. If you can help, please contact me. Thanks Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall,
RE: Certificate of Incoorporation???
Hi, My guess is that it has to do with the Machinery Directive. See Article 4, paragraph 2 and point B of Annex II. This deals with machinery ...that it is intended to be incorporated into machinery or assembled with other machinery to constitute machinery covered by this Directive... Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Veit, Andy [mailto:andy.v...@mts.com] Sent: Thursday, June 28, 2001 2:28 PM To: emc-p...@majordomo.ieee.org Subject: Certificate of Incoorporation??? Hello- Can someone explain to me what a Certificate of Incorporation is? One of our vendors wants to supply this in lieu of an EU Declaration of Conformity for CE compliance. Can someone enlighten me? Thanks again- -Andy Andrew Veit Systems Design Engineer MTS Systems Corp Ph: 919.677.2507 Fax: 919.677.2480 1001 Sheldon Drive Cary, NC 27513 --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall, --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall,
RE: Serial Number Format - Medical Devices
Hi Dick, Section (e) deals with items that have an shelf life (i.e. sterile products). Having the actual month and year makes perfect sense. Active devices usually are not date sensitive, except for usable lifetime (i.e. 10 years) as defined by the manufacture. The year of manufacture only, needs to be on the label per 13.3.l. It was my understanding that the actual year should be on the label. Symbol 6.16 of ISO 15223 can be used or the year (i.e. 01) has to be an integral part of the serial number. If it was a code in the serial number, how would the user know when the usable lifetime is up? Ned Devine Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Dick Grobner [mailto:dick.grob...@medgraph.com] Sent: Monday, June 25, 2001 7:02 PM To: IEEE EMC-PSTC E-Mail Forum (E-mail) Subject: Serial Number Format - Medical Devices A question to the group: Referencing the Medical Device Directive, Annex I, paragraph 13.3 The label must bear the following particulars: (l), year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number. One of my colleagues (in another company) was told by their Notified Body (BSI) that it has been interpreted (by whom?) that this means the month and year needs to be embedded into the actual serial number, such as XXZZ1 whereas XX: month and ZZ: year (or similar). We have never encountered this with our Notified Body (TUV). Our S/N's cross back to a SN log which will reveal the month and year of manufacture. Who is right? Does anyone know where this official interpitation is coming from? The rational behind it? Thank You Dick Grobner Medical Graphics Corporation 350 Oak Grove Parkway St Paul MN 55127 651-766-3395 651-766-3389 (fax) dick.grob...@medgraph.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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall, --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall,
RE: Production Line Test Requirements - Medical Devices
Hi Dick, The requirement for using 10 to 25 Amps comes from the test house. It is their mark. If you want to use it, they can require you to do anything they want. Is it fair, no. Does the requirement make engineering sense, no (I believe that Rich Nute did an article on how this requirement did not identify anymore failures than the simple ohm meter did). Do you still have to do it, yes! If you are just declaring conformity for the MDD, use your risk analysis (i.e. EN 1441) to show that the risk of using a ohm meter is an acceptable one. Your NB might review it, but you should be able to switch to the ohm meter. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall,
RE: Medical Directive
Hi, The scope of the MDD (see below) says nothing about whether a device is mobile or not. Please look at IEC 60601-1-1 for systems. This gives examples of what certifications devices need when used in a hospital. i.e. in the patient vicinity. For the EMC questions, I am sure someone has this information. If you place the device on the market or into service, it must have the CE marking. There is an Annex in the MDD (X) that talks about Clinical Evaluations. You might be able to use this. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail 2. For the purposes of this Directive, the following definitions shall apply: (a) medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; -Original Message- From: Binnom, Cyril A [mailto:binno...@ems-t.com] Sent: Friday, April 27, 2001 10:46 AM To: emc-pstc Subject: Medical Directive Group: I am attempting to send ITE equipment to the European Union, and the unit will be used in a hospital environment. I have no problem testing to the Medical or EMC Directive, whichever is applicable, but I am in need of some clarification My questions are: * I have been told that if the unit is mobile, (which it is) then the Medical Directive applies. There is no patient interface but it will be in a hospital environment. * Will EN 60601-1-2 (Medical Immunity) be upgraded in the near future as I do not want to test to the current standard and have to go back in a year or two and retest the unit, and if so is there a proposed standard for review. * Does the unit under EN 55011 have to be tested to Class B or Class A limits for hospital use. I have been told that in Sweden and Germany, Class B is mandatory. * A demo has been requested A.S.A.P. Does the demo have to be CE mark, (it will not be sold) or is there room or a clause that allows this one unit to be shipped to the EU while compliance is being completed. I am under the assumption, that the demo will be used in the hospital during this time. Regards, Cyril A. Binnom Jr. EMI/EMC Approvals Engineer LXE, Inc. (770) 447-4224 Ext. 3240 (770) 447-6928 Fax binno...@lxe.com --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall, --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall,
RE: EN60950 (UL1950, IEC 60950) On off switch marking.
Hi,
Well here is the other side to keep it 50-50.
I have understood the requirement to be that the O symbol can only be used
when all power has been disconnected from the unit. I believe that if you
used a single pole switch on a grounded neutral system, it would be OK. Of
course, this is only OK if you can be sure that you know which will be the
neutral.
Ned
Ned Devine
Program Manager III
Entela, Inc.
3033 Madison Ave. SE
Grand Rapids, MI 49548
616 248 9671 Phone
616 574 9752 Fax
ndev...@entela.com e-mail
-Original Message-
From: geor...@lexmark.com [mailto:geor...@lexmark.com]
Sent: Friday, April 27, 2001 12:47 PM
To: Rick Linford
Cc: emc-p...@majordomo.ieee.org
Subject: Re: EN60950 (UL1950, IEC 60950) On off switch marking.
Rick,
My opinion based on my understanding of IEC 60950.
Whether an on/off switch breaks one or both sides of the line, the
equipment will be either on or off respectively, as either breaks the
electron path.
It is true that breaking only one side may leave the electronics hot
if the plug or socket allow for the neutral to be the open side. However,
the device will be off.
As I recall, the marking instructions you referenced make no mention of
whether one or both of the mains leads are opened by the switch. Therefore,
the I or O apply only to whether the device is on or off, which results
from
breaking either or both sides of the line.
George Alspaugh
Lexmark International Inc.
Rick Linford rlinford%sonicwall@interlock.lexmark.com on 04/27/2001
12:25:19 PM
Please respond to Rick Linford
rlinford%sonicwall@interlock.lexmark.com
To: emc-pstc%majordomo.ieee@interlock.lexmark.com
cc:(bcc: George Alspaugh/Lex/Lexmark)
Subject: EN60950 (UL1950, IEC 60950) On off switch marking.
Hi All,
When a switch opens only one leg of the mains to control power to
equipment should it be marked with the l and O?
Background:
Three different engineers from three different NRTLs indicated it is
permitted, two even required it. A different engineer for one of the
NRTLs and two other respected individuals indicate it is prohibited. It
will be interesting if members of this list will have the same 50/50
split or if there is a correct answer.
(single phase 100 to 240 VAC, 2A, 50-60 Hz, intended to be shipped US,
Canada, EU and generally internationally)
To help, IEC 60950 (1999), section 1.7.8.3 Symbols, is shown below.
Where symbols are used on or near controls, for example switches, push
button, etc., to indicate ON OFF conditions, they shall be the line
l for ON and the circle O for OFF (60417-1-IEC-5007 and
60417-1-IEC-5008). For push-push type switches the symbol {line in side
the circle} shall be used (60417-1-IEC-5010).
It is permitted to use the symbols O and l to indicate the OFF and
ON positions of any primary or secondary power switches, including
isolating switches.
A STAND-BY condition shall be indicated by the symbol {line breaking
the circle at the top} (60417-1-IEC-5009).
My bias was not included in the 50/50 statistics noted above but I
believe it is required.
Rick Linford
Regulatory Engineer
SonicWALL
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RE: Orange Power Outlets
I did a search of the 1999 NEC and this is the closest I can find. 410-56, (c) Isolated Ground Receptacles. Receptacles intended for the reduction of electrical noise (electromagnetic interference) as permitted in Section 250-146(d) shall be identified by an orange triangle located on the face of the receptacle. Receptacles so identified shall be used only with grounding conductors that are isolated in accordance with Section 250-146(d). Isolated ground receptacles installed in nonmetallic boxes shall be covered with a nonmetallic faceplate. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Anil Allamaneni [mailto:a...@acc.com] Sent: Friday, March 23, 2001 12:11 PM To: emc-pstc Subject: Orange Power Outlets Greetings folks, I seem to remember from my previous life in test labs, that orange colored power outlets are exclusively for non-US power, specifically 230V AC. Just did some reading on the National Electric Code online and cannot find this rule anywhere. What gives? Thanks Anil --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall, --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall,
RE: Translation Requirements
Paul, This is not from the EMC or LVD , but you mentioned 1010-1 which includes laboratory equipment, so for the medical directives, including the one for in vitro diagnostic medical devices, it is very clearly specified. For the MDD, See article 4, paragraph 4 Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use. For the IVDD, See article 4, paragraph 4 Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax ndev...@entela.com e-mail -Original Message- From: Finn, Paul [mailto:fi...@pan0.panametrics.com] Sent: Thursday, March 22, 2001 1:35 PM To: 'emc-pstc' Subject: Translation Requirements Can some one point out the specific requirements, if any, that are imposed on translating manuals into the language of the country they are to be used. Specifically if you CE label in accordance with 89/336/EEC (EN 61326) and 73/23/EEC (1010-1). In reviewing the archives I could only find mention that the manufacturer is to supply a version of the manual which is agreed upon in that country and English is most common. Your comments would be greatly appreciated. Paul Finn Panametrics 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall, --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall,
RE: DoC
Hi, For the Medical Directives and I am assuming, for the others, the manufacturer is the company who's name is on the product. In your example, Company B is responsible for the technical file and DoC. If they are basing their DoC on a technical file held by Company A, they should have contractual access to that information. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: wo...@sensormatic.com [mailto:wo...@sensormatic.com] Sent: Tuesday, February 27, 2001 10:08 AM To: emc-p...@majordomo.ieee.org Subject: DoC Companies A and B are located in the EU. Company A manufacturers a product and applies the name of Company B. Company B sells the product to a customer and the product is shipped from Company A direct to the customer. Which company is responsible for the technical file and issuing the DoC? Richard Woods --- 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: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall, --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@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://www.rcic.com/ click on Virtual Conference Hall,
RE: Product Marking - new twist
Hi, Just having NRTL accreditation from OSHA is not necessarily enough. Some states (i.e. North Carolina and Oregon) and local authorities (i.e. City of Las Angeles) have there own requirements. These local regulations can override the OSHA NRTL program. The NRTL must have/get approval from these municipalities. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Veit, Andy [mailto:andy.v...@mts.com] Sent: Friday, January 26, 2001 7:06 AM To: 'Rich Nute' Cc: 'emc-p...@majordomo.ieee.org' Subject: RE: Product Marking - new twist Rich- Thanks for the detailed reply to Chris's questions. Is it possible that a piece of equipment with an NRTL listing can be disconnected by a local electrical inspector/electrician enforcing the NEC because that paticular NRTL is not approved in their jurisdiction? Doesn't the NRTL approval by OSHA take precedence over whether or not the local authorities accept the NRTL's listing? Thanks- -Andy Andrew Veit Systems Design Engineer MTS Systems Corp Ph: 919.677.2507 Fax: 919.677.2480 1001 Sheldon Drive Cary, NC 27513 -Original Message- From: Rich Nute [mailto:ri...@sdd.hp.com] Sent: Thursday, January 25, 2001 1:39 PM To: chris.maxw...@gnnettest.com Cc: emc-p...@majordomo.ieee.org Subject: Re: Product Marking - new twist Hi Chris: For instance, one of the messages says that the NEC gives an electrician the right to unplug an un-NRTL-marked piece of equipment. Another message states that the NRTL's mark is the proof of product safety. NRTL is a designation issued by OSHA. Approved is a designation used by the NEC. An NRTL may or may not be approved, depending on the jurisdiction, i.e., the authority enforcing the NEC. The authority enforcing the NEC can disconnect any equipment that is not approved. The electrician may be delegated (through licensing) to enforce the NEC, including disconnecting equipment that is not approved. 1. Are other certifications from other labs, such as A2LA and/or NVLAP allowed as long as there is a test report? Under the NEC, equipment must be approved. Approved is defined as acceptable to the jurisdiction enforcing the NEC. The jurisdiction decides approved on a lab-by-lab basis, and sometimes by standards or equipment type covered by that lab. Ultimately, it boils down to a certification mark from one of the labs accepted by the local jurisdiction. The test report is nothing more than a record maintained by the certification house for its own purposes of granting the right to use the mark on the equipment. Under the NEC (and OSHA), it is possible to install a non-certified product provided it is tested in place. In such a situation, the test report may be highly useful. (In Europe, the test report is essential, as Europe relies on the manufacturer proving the safety of the product.) 2. Does it matter what the voltage rating of the product is? No. Safety certification process almost always requires the product to be safe (and therefore certified) in accordance with the product's ratings, including its input voltage rating. Although rare, it is possible to certify a multi- voltage product for one voltage by one lab and another voltage by another lab. This is done by agreement between the submittor and the lab. In such a case, the voltage for which the certification applies is specifically related to the certification mark. 3. For products with external AC power supplies, would the NRTL mark need to be on the supply and the product? Or the supply only? The external ac power supply must be approved. The product may or may not need to be approved. If the rated input voltage exceeds 30 V rms or 42.4 V dc, then it must be approved (per the NEC). If the rated input voltage is less than 30 V rms or 42.4 V dc, then the NEC does not require it to be approved; it is a manufacturer's option whether to seek third- party certification. 4. Does it matter where the product is used? (home, farm, factory ...) The NEC applies to almost every location (except electric utility locations). Best regards, Rich --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help
RE: Lights for 3-meter Chamber
Hi, Be careful of the hot light bulbs. I was witness to a fire when the foam tiles on the ceiling came loose and touched the hot flood lamps. The fire smoldered for a long time till the fire sprinklers activated. I also learned that normal sprinklers heads don't spray up. Because the sprinkler heads were mounted below the foam tiles, it just sprayed water onto the floor and not the foam. The fire department had to come in with hoses and put out the fire. Also, don't forget to put sprinklers above the chamber. If the fire gets out of the chamber (say through the vent in the top) you want to put it out. You don't want the fire department to use their hoses to put it out. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Ken Javor [mailto:ken.ja...@emccompliance.com] Sent: Friday, January 26, 2001 2:15 AM To: Price, Ed; 'marti...@appliedbiosystems.com'; emc-p...@majordomo.ieee.org Subject: Re: Lights for 3-meter Chamber One caveat. If you are on a budget for a room, fluorescents can be very handy in that they don't add nearly to the heat load that needs to be removed like incandescents. You need enough incandescents to light the room sufficiently when the fluorescents are turned off during an RE test. -- From: Price, Ed ed.pr...@cubic.com To: 'marti...@appliedbiosystems.com' marti...@appliedbiosystems.com, emc-p...@majordomo.ieee.org Subject: RE: Lights for 3-meter Chamber Date: Thu, Jan 25, 2001, 9:23 AM -Original Message- From: marti...@appliedbiosystems.com [mailto:marti...@appliedbiosystems.com] Sent: Wednesday, January 24, 2001 6:15 PM To: emc-p...@majordomo.ieee.org Subject: Lights for 3-meter Chamber We are setting up a 3-meter chamber to do some pre-compliance measurements. What are the best low emissions lights to purchase for this chamber. Please be specific as to manufacturer and models. Thanks Joe Martin Applied Biosystems --- The choice for internal chamber lighting is still simply incandescent bulbs. Avoid anything that uses fluorescent lights, and also avoid any electronic ballast or driver circuitry. Incandescent lamps within chambers have a reputation for burning out quickly. This is because they are turned on and off so much (I turn mine off whenever I close the chamber door), and also because the lights are operated off of filtered power. When the lights are off, there is often very little load on the output side of the room filters, causing a slight voltage rise. Thus, the lights are turned on usually with a slightly high nominal voltage condition. You can use expensive traffic light lamps, or you may find some industrial bulbs rated for 130V or so. My position is ordinary light bulbs are cheap. I just keep a case handy, and I bought one of those extension wands so that I can change a bulb without even getting a ladder. I also installed a couple of 150W floodlights, so that I can switch them on to help my digital camera's flash when I take pictures. (The anechoic wall treatment really soaks up the available light; I usually force the camera up the equivalent of two f-stops, even with the floodlights.) Regards, Ed Ed Price ed.pr...@cubic.com Electromagnetic Compatibility Lab Cubic Defense Systems San Diego, CA. USA 858-505-2780 (Voice) 858-505-1583 (Fax) Military Avionics EMC Services Is Our Specialty Shake-Bake-Shock - Metrology - Reliability Analysis --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson
RE: creepage distances (EN61131-2)
Hi, I believe your problem is in the interpretation of the words (Basic and supplementary) used in the table 23. In this case, you should read the word and as or and not plus. In fact in IEC 61010-1, table D.4, it states Basic Insulation or Supplementary insulation. From this table, the value for 150 up to 300 Vrms or d.c., pollution degree 2, installation Category II is 1.5 mm on printed wiring boards (coated or not coated). This is very close to your 1.6 mm. As far as the coatings go, in IEC 61010-1, table D.3, for pollution degree 1, installation category II, there are only numbers for printed wiring boards. There is no reference to coated or not coated. In your case, it makes sense that the numbers are the same for coated PWB's and PWB's located in pollution degree 1 areas. I can only guess that the standard writers wanted to make sure that people understood that coated PWB's are pollution degree 1. editorial - Should all standards be written the same, sure. Should the values be the same, no. Depending on where and how a piece of equipment is used, I would expect different values. Do I want 4000 V rms dielectric and 8.0 mm between primary and SIP/SOP (SELV) parts in medical equipment? Yes! Do I also want to limit the patient leakage current to as low as 10 micro amps? Yes! Do I need these levels for my computer? No. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Dan Kinney (A) [mailto:dan.kin...@heapg.com] Sent: Thursday, December 21, 2000 10:18 AM To: Ned Devine; Emc-Pstc (E-mail) Cc: jjuh...@fiberoptions.com Subject: RE: creepage distances (EN61131-2) Ned, John, and EMC-Pstc Thanks for your responses. You almost convinced me (at least you started to) but the standard is either so badly written that it still could be interpreted multiple ways or it is using different terminology than the standards you are using. Let me elaborate a little more. The table I am most concerned with (Table 23) will serve as an example of the others and if I can come to a good understanding of it, I'll understand the remainder of the document. This may be old news to all of you but let me quote paragraph 1.4.26 which defines the four levels of insulation: 1) basic insulation: Insulation applied to live parts to provide basic protection against electric shock. 2) supplementary insulation: Independent insulation applied in addition to basic insulation in order to ensure protection against electric shock in the event of a failure of the basic insulation. 3) double insulation: Insulation comprising both basic insulation and supplementary insulation. 4) reinforced insulation: Single insulation system applied to live parts which provides a degree of protection against electric shock equivalent to double insulation under the conditions specified in this standard. Table 23 is as follows: Table 23 - Minimum creepage distances for printed wiring boards (Basic and supplementary) CIRCUIT Protective UncoatedUncoated VOLTAGE Coating Pollution Pollution Degree 1Degree 2 -- 0-500.025 0.025 0.04 50-100 0.1 0.1 0.16 100-160 0.250.250.4 160-320 0/750.751.6 As you can see, there is only one value for Basic and supplementary insulation. This clause is exactly as it appears in the definition of double insulation. The table does not provide one number for Basic insulation and another number for supplementary insulation. Thus I conclude these numbers are for the combined Basic and supplementary insulation, which is, by definition, double insulation. Please correct me if I'm wrong. How do these creepage numbers stack up against the standards you use for the same voltages? Shouldn't they be the same? Also note, there is a column for protective coating and another for pollution degree 1. If they meant for these two to mean the same thing, I would think they would have only one column for pollution degree 1/protective coating. Furthermore, referencing the definitions for the pollution degrees, pollution degree 1 says nothing about coating but does talk about dry, non-conductive pollution - again, it says nothing about coatings and nothing about hermetically sealed containers. How does your standards read regarding the degrees of pollution? As you can see, I'm still confused. Are the pollution degrees and types of insulation intended to be universal within all European Norms? If so, where does it say so and where does it give the definitive reading of each? Again, I appreciate your feedback. I've seen many instances where members of this group have commented on the extreme value they have received from information gained within. I
RE: Responsibilities
Hi, My understanding is that the DOC has to be signed by an officer of the company that has the responsibility and authority (stop shipment if not in compliance) of the product. In your case the Compliance Engineer may have the responsibility but probably not the authority. The President would have both the responsibility and authority and unless there was fraud involved, he is going to be liable. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Mark Schmidt [mailto:mschm...@xrite.com] Sent: Wednesday, December 20, 2000 1:55 PM To: Courtland Thomas; emcpost Subject: RE: Responsibilities Courtland, It has always been my understanding that the Company/President or VP of Engineering is ultimately responsible for product compliance. Ignorance of Regulatory law at a senior management level is not a valid excuse. Granted the Compliance person may be terminated in the process, but the responsibility resides with the Company. Mark Schmidt -Original Message- From: Courtland Thomas [mailto:ctho...@patton.com] Sent: Wednesday, December 20, 2000 4:06 PM To: emcpost Subject:Responsibilities Hello group, I have a question concerning responsibility when signing off on compliance issues. Who is ultimately responsible for the product, the compliance engineer or the company. Let's say that a device has been 'Self Declared' to be 'CE' compliant. The D of C is signed by the compliance engineer as well as the President of the company. For some reason, whatever it may be, the unit is found to be non-compliant. Who gets locked up? I may be exaggerating somewhat, but you get the idea. Courtland Thomas --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: OEM Issues (EU context)
Hi, This is defined in some of the newer directives. i.e. the IVD Directive, 98/79/EC, Article 1, paragraph f. I have to assume that what is a manufacture in one directive is the same in all of the other directives. They wouldn't have different definitions, for the same word, in different directives would they? :-) (f) 'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient; Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: acar...@uk.xyratex.com [mailto:acar...@uk.xyratex.com] Sent: Wednesday, December 13, 2000 12:41 PM To: wmf...@aol.com Cc: emc-p...@ieee.org Subject: Re: OEM Issues (EU context) WmFlanigan Our interpretation and how we always treat such issues is, as the seller of the equipment you are responsible to ensure it meets the requirements of the Low Voltage and EMC directive. As you are re badging it, you will need to draw up your own DOCs. Off course you can base your conformity to the directives on the DOC provided with the original product. If you were not re badging, then no new DOC required. Simple rule, if your name is on the front, you are claming responsibility for the product. wmf...@aol.com wrote: Similar to the 'SAFETY LISTING' thread this week: As a manufacturer of electrical equipment, we purchase another manuf's power supply, CE-marked by them with a copy of their Declaration of Conformance. We then re-label it with our own label, make only minor physical changes, document the product and sell it in the EU. In the event that the unit's conformance to the Electromagnetic Compatibility Directive (89/336/EEC) or to the Low Voltage Directive (73/23/EEC) is challenged, who is liable to represent the product? My guess is that we are ast least as responsible as the 'manufacturer', above, but mine is not a legal opinion. Anyone out there (especially on the continent)in a position to offer advice on how I should proceed? Many thanks. WmFlanigan --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org -- Andrew Carson - Product Safety Engineer Xyratex Engineering Laboratory Tele 023 92496855 Fax 023 92496014 --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: component spacing question
Hi, I agree with Rich. This never made any sense to me even when I worked at UL. Why are spacing not critical where the leads enter the case but are critical on the PCB? Oh well, as Rich mentioned, there is an out. In many cases the insulation if OPERATIONAL and can be short-circuited. For example, see UL 1950, Third Edition, Clause 5.4.4 c). Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Rich Nute [mailto:ri...@sdd.hp.com] Sent: Wednesday, November 29, 2000 7:38 PM To: matsu...@curtisinst.com Cc: emc-p...@ieee.org Subject: Re: component spacing question Hi Ken: I wanted to pose the group a question in regards to spacing requirements for the U.S. Many UL standards allow for the exception of components (such as semi conductors, switches, etc) to not meet spacing requirements (as they usually have different standards they meet anyways) The question is what about PCB trace spacing for those components, such as a capacitor in a switching power supply to ground. High voltage, the components is an exception, but what about the pads under the component, are they required to meet the spacing requirements, or would that fall under the component exception? You've brought our attention to the anomaly that a component must meet its spacing requirements, and that the end-product (i.e. PWB) must meet its spacing requirements, even when the component requirements are less than that of the end-product. From an engineering point of view, this is nonsense. Nevertheless, our standards have such requirements, and our certification houses must enforce such requirements. There are several options: 1) Design the PWB to meet the spacing requirements by trimming edges off circular pads, or by bending the component leads. 2) Test by short-circuiting the spacing and observing the results (i.e., no shock or fire or damage to basic insulation). This is especially appropriate for semiconductors since, by definition, they alternate or vary between open and nearly short. 3) Remember that spacings is a special case of insulation, either air insulation (clearance) or a surface insulation (creepage). Only those insulations that are required by the safety standard (i.e., basic, supplementary, or reinforced) are subject to the spacings requirements. Typically, these insulations only exist between primary and ground, and between primary and secondary. Typical products do not have components between primary and ground and between primary and secondary except those specifically rated for such use such as Y-caps, transformers, and opto-isolators (and which therefore meet the spacing requirements of the end-product). Some standards may require pole-to-pole spacings in primary circuits. In this case you must measure the voltage and then determine the spacing from a table. A typical SMPS has lots of low-voltage control circuits with respect to the negative rail. So, you can lump all those circuits together as not requiring insulation from each other. Then, they can be taken as a whole and spaced from the positive rail. That will generally only leave the bulk capacitor and the switching transistor(s) as requiring spacings. And, the snubber circuit, which can be considered a voltage divider so that the spacings across any individual snubber component need not be the full voltage across the snubber. Etc. It really makes no sense to require a PWB to have greater spacings than the component itself. It further makes no sense to enforce spacings across capacitors (that are not Y capacitors) and semiconductors and similar components. Internally, these components do not have insulations that are equivalent to their terminal spacings or to the PWB spacings. So, why require a higher level of insulation than the device itself can provide? Short-circuiting of the component will tell the story of whether the circuit is safe; if safe, then the spacing is inconsequential to the safety of the product. Best regards, Rich --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: majord...@ieee.org with the single line
Standards for a Position Indicator
Hi, I am currently researching the appropriate standards (UL, CSA, IEC) for a position indicator. The indicator is mounted on a valve. It indicates whether the valve is open or closed. It is a 10 to 30 Vdc, 150 mA, PNP device. The valve is used in the pharmaceutical industry and controls the flow of sterile liquids. After doing some research, I have come up with two options. 1. Laboratory, control and measurement equipment. UL 3101-1, CSA 1010.1 and IEC 61010-1 2. Proximity switches. IEC 60947-5-2, UL 508 (I don't think the UL version of IEC 60947-5-2), CSA ?? Does anyone have any comments or ideas? Thanks Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
Automotive EMC Directive
Hi, I have been volunteered to research the Automotive EMC Directive. What I have found so far is, - The directive is 95/54/EC which is an amendment to 72/245/EEC. - The directive is an old approach and has all of the necessary test procedures and methods in the directive. - Self declaration is not allowed. You need a technical service to approve your unit. - The mark is the e mark and not the CE marking. - The effective date is 01 October 2002. - The tests listed in the directive are radiated broadband emissions, radiated narrowband emissions and radiated immunity. The questions I have are. - Is what I have above correct? - How do I get a copy of the directive(s)? - Does anyone have a list of the technical services, or know where I can get one? - Does anyone have a sample of the e mark, or know where I can get one? - Are there any labs in the USA that do this type of testing? Thanks Ned Devine Entela, Inc. 3033 Madison Ave. S.E. Grand Rapids, MI 49548 Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: Label Rub test per IEC60950
Hi, The requirement is for The petroleum spirit to be used for the test is aliphatic solvent hexane having a maximum aromatics content of 0,1 % by volume, a kauri-butenol value of 29, an initial boiling point of approximately 65 °C, a dry point of approximately 69 °C and a mass per unit volume of approximately 0,7 kg/l. Our Chemist researched it and found it is Hexane, 95+%. The Aldrich Cat. No. is 20,875-2. The CAS number is 110-5A-3. The Isopropyl Alcohol is 100% (not rubbing alcohol) and is a very aggressive solvent. It is at least as harsh as the Hexane. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Robert Johnson [mailto:robe...@ma.ultranet.com] Sent: Sunday, October 08, 2000 11:20 PM To: E Eszlari Cc: emc-p...@majordomo.ieee.org Subject: Re: Label Rub test per IEC60950 As I recall, the chemical that was described is what is sold in the US as kerosene. It appeared way back in the early UL standards that way. Since this is a petroleum distillate characterized mainly by its molecular weight and what temperature it comes off the refining process, describing it is kind of like coming up with a chemical formula for milk. Too messy to try. The term kerosene was not sufficient to properly describe it worldwide, so this description was what was recommended by those in the business. Many have also used cigarette lighter fluid for the test. Functionally it is pretty equivalent, just a lighter distillate. The container's much more convenient. Bob E Eszlari wrote: Hi Doug, I think you will find that the common mineral spirit found in your local hardware store is used by most companies to perform the test in order to get a good idea if the label and print will pass. I have found that UL will accept the results. By the way, the gallon of mineral spirits I have at home is also labeled petroleum spirit. If you are doubtful of this test result, you may want to have an agency such as UL do the test for you or use an approved label system. In my experience I have found mineral spirit to be a more harsh chemical than Isopropyl Alcohol. The alcohol test is performed on labels that are used in medical environments per IEC 60601. Ed From: Massey, Doug C. masse...@lxe.com Reply-To: Massey, Doug C. masse...@lxe.com To: 'IEEE Forum' emc-p...@majordomo.ieee.org Subject: Label Rub test per IEC60950 Date: Fri, 6 Oct 2000 10:22:27 -0400 Does anyone know what the trade name for the chemical used for the rub test in 60950 clause 1.7.15 is ? The standard calls it petroleum spirit, then describes an aliphatic solvent hexane, with several properties, none of which are a chemical formula. Is it common mineral spirits available at most hardware stores? Also, is Isopropyl Alcohol a more harsh solvent than the petroleum spirits? Thanks Doug Massey Safety Approvals Engineer LXE, Inc. Norcross, GA., USA Ph. (770) 447-4224 x3607 FAX (770) 447-6928 e-mail: masse...@lxe.com Cruise our website at: http:\\www.lxe.com --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org _ Get Your Private, Free E-mail from MSN Hotmail at http://www.hotmail.com. Share information about yourself, create your own public profile at http://profiles.msn.com. --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society
RE: UL certification and Underwriter Laboratory
Hi, OK, I wasn't going to say anything, but. 1. A UL Listed product complies with all of the applicable requirements. Usually from a standard. 2. A UL Recognized Component does not comply with all of the applicable requirements. That is why they have Conditions of Acceptability. Whether the product is a complete unit or a component is immaterial to whether it is UL Listed or Recognized Component. If it meets all of the applicable requirements, it is Listed. If not, it is a Recognized Component. Now, sometimes UL cheats on this and calls it Classified. Medical equipment is Classified to UL 2601-1. This is mostly because UL does not require you to meet all of the requirements. They say the FDA (US Government agency) covers them. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Peter Merguerian [mailto:pmerguer...@itl.co.il] Sent: Thursday, May 11, 2000 9:49 AM To: Grant, Tania (Tania); emc-p...@ieee.org; 'Jon Keeble' Subject: RE: UL certification and Underwriter Laboratory Hello Tania and All Members, Al is well said, but allow me to add one additional fact. UL also Lists COMPONENTS which an electrician might use in the field; for example closed-loop connectors, quick-disconnet connectors, splicing connectors, fixture wiring, circuit breakers, outlet boxes, etc. These components undergo more rigorous testing than normal components and are always provided with installation instructions limiting the usage; for example a splicing connector may specify the exact crimping tool and the # and size of all the combination of wires to be spliced by that connector. Best Regards At 18:50 10/05/2000 -0700, Grant, Tania (Tania) wrote: John, The 'UbackwardsR' mark' is but one of many UL marks. This is the UL Recognition Mark;-- there are also UL Listing Marks, UL Classification Marks, and perhaps others that I have forgotten.And you are correct that only UL can issue UL marks.However, UL can do this based on CB Scheme reports, provided you have also complied with the U.S. National Electrical Code requirements, which are spelled out as deviation in the UL1950 standard. You should be looking at the UL1950, 3rd edition, which is also harmonized with the Canadian Standards Association and its Electrical Code. (Kill 2 birds with one stone!) Generally speaking, the UL Listing Mark is for end-use product, such as coffee pots, computers, and finished things one can generally buy in the store that perform a function.UL Recognition Marks are for components and incomplete assemblies that are to be placed inside end-use products, where their recognition still has to be evaluated in this final application. For example, power supplies, such as UPS, electronic load boxes, or desk type boxes with power cords which are used for test equipment, would be UL Listed.However, power supplies (transformer/capacitor/choke/etc. circuitry mounted on a printed circuit card) that are sub-assemblies of assorted computer products, would be UL Recognized.That means that this power supply would be further tested in you end-use product to be sure that you are not overloading it, and that you are using it within its rated specifications. You might find the following web sites helpful. http://ulstandardsinfonet.ul.com/ http://ulstandardsinfonet.ul.com/ http://www.ul.com/ http://www.ul.com/ Tania Grant, tgr...@lucent.com mailto:tgr...@lucent.com Lucent Technologies, Intelligent Network Unit Messaging Solutions Group -- From: Jon Keeble [SMTP:j.kee...@fairlightesp.com.au] Sent: Wednesday, May 10, 2000 4:05 PM To: emc-p...@ieee.org Subject: UL certification and Underwriter Laboratory I work for an Australian company that has always assumed that 'having UL' means 'having the 'UbackwardsR' mark'. The facts as I understand them are (1) a UL1950 certificate is required (2) only an NRTL can issue this certificate (3) The CB scheme was created to allow people in countries like Australia to achieve accreditation in other countries (including the US) through their local test house (4) the mark of any test house qualified to issue a UL1950 certificate is all that is required In our case, there are people in neighboring countries that (1) participate in the CB scheme (2) recognize some Australian test houses (none of which can issue UL1950) (3) are qualified to issue 1950 Our marketing department is fearful that not having the 'UbackwardsR' mark will raise questions in the mind of prospective customers. I'd be very appreciative of some candid feedback. - Jon Keeble Fairlight Hardware Engineering Manager 02 8977 9931 j.kee...@fairlightesp.com.au _ The bounds of Time, Space or Mechanics should never stand in the way of a perfectly good idea
RE: Actual requirement or money making scheme?
Hi, We discussed this at the US National Committee of the IECEE on 19 April 2000. There is some confusion on the interpretation of this requirement. It was explained, that an amendment is NOT a correction or a change to a part number. An amendment is when new data/pages are added. Using Brent's example of adding an alternate plastic. If no tests are necessary, then it would not be an amendment. If there was testing, then it would be an amendment. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Matthew Meehan [mailto:mee...@i-kk.co.jp] Sent: Thursday, May 11, 2000 1:35 AM To: emc-p...@ieee.org Subject: RE: Actual requirement or money making scheme? Hi Brent, Subject: Actual requirement or money making scheme? Definitely an actual requirement. (about the rest of your subject: No comment). Decision: Original CB Test Reports can be subjected to three (3) amendments only, after which a new CB Test Report and associate CB Test Certificate shall be issued. Explanatory notes: Experience shows that by making more than three amendments to a CB Test Report the technical features of the initial product becomes such that the tracking against the Master File can be lost. To get your very own copy go to: http://www2.imq.it/ctldecisions/collect.htm choose sheet 291 (bottom right) Regards, Matt Subject: Actual requirement or money making scheme? Hello wise colleagues - Just recently, we have decided to add some alternate components to one of our CB Reports and was informed by a particular agency that we needed to have a new CB Report issued since we already have 3 updates to the existing report. In the past, we were able to add an alternate plastic to the CB report and just pay for an addendum (few thousand...I know, I am already getting ripped off). But, now to add an alternate component and pay for a full CB Report and Certificate?! That does not make sense. After talking to the project engineer, he indicated that this is the direction of his organization and this interpretation will be implemented across the board with all member agencies. We only have a few products with few changes. I would hate to work for a computer manufacturer who changes the disk drive manufacturer and model numbers like it was last month's model. Oh yeah, it was last month's model. All I know is that this change in policy will push me well over budget this year. Without turning this into a bashing session of any particular agency, can anyone direct me to an agency that has a more relaxed interpretation of the CB Update requirement? Thank you very much for your time and your expert advice. Best Regards, Brent Taira --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: EN61010-1 Question
Hi, It depends on if the circuit is Hazardous Live. Symbol 12 would only be required if the circuit was hazardous live. 6.3.1 is used to determine if something is Hazardous Live, in normal condition. It has three parts, voltage (6.3.1.1), current (6.3.1.2) and capacitance (6.3.1.3). If your voltage is over the limits in 6.3.1.1, then you have to look at current and capacitance. For your example, the voltage is over the limit (60 Vdc). So we have to look at current and capacitance. For Current, the limit is 2 mAdc when using the circuit in A.1 or A.2. If your circuit is only 200 uA, you should be OK, but check. The limit for capacitance is 45 uC charge (Vdc times Capacitance). You will need to measure the capacitance of the circuit. Don't forget that Clause 6.3 requires that you look at normal and single fault conditions (6.3.2) to determine the permissible limits for accessible parts. You will need to verify that the circuit meets the requirements of 6.3.2.1, 6.3.2.2 and 6.3.2.3 during a single fault. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Loop, Robert [mailto:rl...@hnt.wylelabs.com] Sent: Tuesday, May 09, 2000 11:30 AM To: emc-p...@ieee.org Subject: EN61010-1 Question Group: A question on interpretation of Clause 6.3.1.1 and 6.3.1.2: If a product has an operator accessible cable that exits the equipment and operates normally at a level of 250 Vdc /200 uA, is it required to be marked with the hazardous voltage label? The cable is a probe where the user (a trained technician) could touch bare metal on the probe operating at the level noted. My thanks to those that respond. Sincerely, Robert Loop Engineering Supervisor Wyle Laboratories Product Safety ph - (256) 837-4411 x313 fax- (256) 721-0144 e-mail: rl...@hnt.wylelabs.com --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: IEC601 - Spacings Requirements
Hi, No - There is a draft out for IEC 60601-1, 3 edition. The moved the Creepage and Clearances section from Clause 57.10 to Section 19. But, other than some minor editorial changes, they did not change the requirements. Yes - What they did do is remove from the normative references IEC 60664. Maybe - They now require a risk management process. See Clause 4.6 in the draft. I suppose you could use the risk assessment to prove that the spacing you wanted to use were OK. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Compliance [mailto:complia...@eoscorp.com] Sent: Thursday, May 04, 2000 6:14 PM To: emc-p...@ieee.org Subject: IEC601 - Spacings Requirements All - Is anyone aware of a revision to IEC601 that would affect the creepage and clearance distance requirements? Any details or history would be kindly appreciated. Best Regards, Brent Taira --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: UL544 Leakage Limits Patient Equipment*
Hi, Its been a while since I looked at UL 544, but a few comments. 1. Headphones are an applied part (UL2601-1) or patient connection (UL544). They come into direct contact with the patient. You can argue that they are an ordinary patient connection (Clause 2.18 of UL544). But, it is still a patient connection. The limit is 50 uA for ordinary patient connection. 2. How long is this product going to be in the market? UL 544 goes away on 1/1/2003 for new products and 1/1/2005 for all products. You might be better off going to UL2601-1 now. In UL2601-1 this type of patient connect is Type BF. The patient leakage current limit is 100 uA in normal condition and 500 uA in single fault condition. 3. Call UL. Maybe I missed some out in UL544. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: me...@aol.com [mailto:me...@aol.com] Sent: Friday, March 24, 2000 3:36 PM To: jjuh...@fiberoptions.com; m.r...@ieee.org; emc-p...@majordomo.ieee.org Subject: UL544 Leakage Limits Patient Equipment* Most esteemed colleagues, we are looking for your professional opinion on a UL 544 leakage limit (I think you will find this interesting): 1. This particular product uses a UL 544 evaluated direct plug in power supply with outputs to the patient care equipment. In this case it is a diagnostic unit that sends an audible tone to headphones (audiometer). The plug in power supply Conditions of Acceptability indicate the outputs are not evaluated for patient leads (i.e. applied parts). 2. Table 42.1 of UL 544 specifies leakage limits. patient connection footnote a references testing of patient leads (applied parts) connections. There is no written definition for patient leads or applied parts in UL544. As such NFPA 99 supplements UL 544 as it draws from the NEC and NFPA 99 (referenced in UL 544): NFPA 99 defines the US definition of Patient Lead = A deliberate electrical connection that can carry current between an appliance and patient. It is not intended to include adventitious or casual contacts such as a push button, bed surface, lamp, hand held appliance, etc. 3. As the headphones of this audiometer are clearly not deliberate electrical connections we conclude these are not patient leads (applied parts) which would not fall under the limits for patient connection limits per 544. The applicable limits would be as defined under enclosure or chassis grounded or double insulated Now be careful not to jump to a conclusion yet. You might say enclosure or chassis?, but if you examine this, you will find the footnotes reference UL 544's Enclosure definition: Enclosure = That external portion of an appliance that serves to house or support component parts, or both. Enclosure of patient care equipment likely to be contacted by a patient include, for example, bedside monitors, bed frames, dental chairs, and examination stands. Our conclusion: Due to the US definition of patient leads (applied parts), the earphones of an audiometer (patient care equipment) are subjected to the leakage current limits for enclosure or chassis, and not the limits of patient connection. For this particular application, we conclude that based on the C of As, the output of the power supply has already been evaluated for enclosure or chassis leakage limits. Your Thoughts??? Drew PS: If you care to look, CSA supports this position in that 50uA is related to cardiac tissue limits only. See Appendix A of CSA 22.2 125 (500uA). --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: EN standard for pacemaker immunity
Hi, A couple of comments on the pacemaker standards. 1. Under the AMID, you must involve a Notified Body. The only reasonable route to the CE marking is Annex 2 (full QA) and submittal of the Design Dossier. 2. All accessories to a AIMD (i.e. programmers) are also under the scope of the AIMD. 3. Its been a while since I looked, but I think the correct standard is EN 45502-1. There are a number of part 2's. I am not sure if they have been released. 4. Standards are not that important. Because you have to use a NB for Annex 2 and submittal of the Design Dossier. The NB will tell you what they want to see. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: plaw...@west.net [mailto:plaw...@west.net] Sent: Monday, March 20, 2000 12:46 PM To: EMC-PSTC Subject: Re: EN standard for pacemaker immunity As an excerise, I tried to find the directive that this standard was harmonized under. I looked on the Europa site under the EMC, Medical Device, and Active Implantable Medical Device directives to no avail. http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/re flist.html Is this standard still pending for the EU? On Thu, 16 Mar 2000 09:53:01 -0500, wo...@sensormatic.com wrote: Mike, A1:1996 of EN50061:1995 has the EMC requirements for implantable cardiac pacemakers. It can be ordered on the web from BSI. Richard Woods Sunning in Florida -- From: Michael Taylor [SMTP:mtay...@hach.com] Sent: Thursday, March 16, 2000 9:19 AM To: emc-p...@majordomo.ieee.org Subject: EN standard for pacemaker immunity Greetings all. An issue came up that needs answers as soon as possible. Does anyone in the group know if there are any European standards covering pacemaker (and similar devices) immunity to Electric Magnetic fields. A search of Global Eng. Documents product list proved fruitless. I'm sure there is someone in the group that has the answer. I will be most grateful for any answers or leads on this issue. Best regards. Michael Taylor Snowed-in, in Colorado. --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. 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: Jim Bacher: jim_bac...@mail.monarch.com Michael Garretson:pstc_ad...@garretson.org For policy questions, send mail to: Richard Nute: ri...@ieee.org
RE: Medical safety EMC standards tied together?
Hello,
1. Yes. One of the main goals of the second amendment of IEC/EN
60601-1 was to bring it closer to the Essential Requirements of the Medical
Device Directive. That is why 60601-1 also references requirements for
biocompatibility and risk analysis.
Also, the EN version of 61010-1 has a requirement for compliance to the EMC
directive.
2. According to my records, A2 to EN 60601-1 was published in the OJ
(for the MDD) in C 307 on 18 November 1995. EN 60601-1-2 was published in
the OJ (for the MDD) in C 204 on 09 August 1995.
I thought that the effective date of the second amendment for IEC 60601-1
was the date of publication (1995). I would assume that the effective date
for the EN version would also be the date of publication (1995).
There was a lot of complaints about this, because A2 also required the
remote end of patient leads to be touch proof. But, the FDA also required
it, so manufactures gave up.
FYI - The history behind that requirement, was that a nurse in a Chicago
hospital, plugged in the remote ends of an apnea monitor cable, for an
infant, into a IEC 320 detachable power cord. Seems the lead were colored
Black, White and Green. If the USA, hospital grade power cords have clear
ends. The nurse saw the Black, White and Green wires in the IEC 320
connector and plugged in the leads. The infant died. I believe that the
FDA had reports of 8 similar incidences.
Ned Devine
Entela, Inc.
Program Manager III
Phone 616 248 9671
Fax 616 574 9752
e-mail ndev...@entela.com
-Original Message-
From: plaw...@west.net [mailto:plaw...@west.net]
Sent: Tuesday, February 29, 2000 5:45 PM
To: EMC-PSTC
Subject: Medical safety EMC standards tied together?
I recently found out something interesting, and wanted to verify it.
IEC 60601-1 is a standard dealing with electrical safety of medical
equipment, and has two amendments.
IEC 60601-1-2 is a standard dealing with EMC aspects of safety of
medical equipment.
IEC 60601-1 Amendment 2 specifies that paragraph 36 ('Protection
against hazards from unwanted or excessive radiation - Electromagnetic
compatibility') be changed
From'Under consideration'
To 'See IEC 601-1-2'
1) Does this hold for the EN versions as well? Do statements of
compliance with the basic electrical safety standard automatically
include EMC testing as well?
2) The EN versions were published in the OJ in June 1999. What is the
DOW of these specifications (if there is one)?
-
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RE: Annex F - groove vs. slot
Hi, I have always interpreted the requirement to include slots. My thinking was that what ever could bridge a groove could also bridge a slot. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Dirk Atama [mailto:dirk_at...@yahoo.com] Sent: Monday, January 24, 2000 6:28 PM To: EMC PSTC Subject: Annex F - groove vs. slot 950 creepage experts- When applying Annex F, Fig. F.1 (narrow groove) and Fig. F.2 (wide groove), requirements to PWB's, does one have to abide by the minimum value of X only for grooves, or also for slots punched all the way through the PWB? It makes sense that if a groove is particularly narrow, a small accumulation of contamination would negate any creepage gained from having the groove. However, what about a slot that goes completely through the board? Would contamination not collect in a slot as it would in a groove, and therefore the slot can be any width (therefore forcing the creepage measurement to be made around the edge of the slot)? We're thinking of an application between pins of an SMD multi-pin telco isolation transformer package: adjacent pins and their solder pads don't meet the required creepage, but if we punch slots through the PWB between pads, can we then measure our creepage around the edge of the slot? In this way we can create as much creepage as we need by simply lengthening the slot. We're thinking of punching a slot about 0.2-0.3mm wide between solder pads, of sufficient length to give us the required creepage. Any comments? Anyone know the history and rationale of this Annex F X requirement and can comment? Thanks, folks. Dirk __ Do You Yahoo!? Talk to your friends online with Yahoo! Messenger. http://im.yahoo.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Competent Authorities
Hi Mark, No. The MDD, Article 14 address this. You only have to register with the CO of the country where you have your authorized representative. But, I have heard that some countries have passed national laws requiring you to register all devices. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com Article 14 Registration of persons responsible for placing devices on the market 1. Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned. 2. Where a manufacturer who places devices referred to in paragraph I on the market under his own name does not have a registered place of business in a Member State, he shall designate the person(s) responsible for marketing them who is (are) established in the community These persons shall inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned. 3. The Member States shall on request inform the other Member States and the Commission of the details referred to in paragraphs 1 and 2. -Original Message- From: Mark Schmidt [mailto:mschm...@xrite.com] Sent: Monday, January 24, 2000 12:00 PM To: emc-p...@majordomo.ieee.org Subject: Competent Authorities Dear Members, In the EEC if I register a Class I Medical Device with a Competent Authority in one Membered State, must I register with other Competent Authorities as we eventually market product their State. All input is appreciated. Regards, Mark Schmidt X-Rite Incorporated Grandville, MI U.S.A. mschm...@xrite.com phone - 616 257 2469 - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Capacitors to Ground
Hi, I was quoting from the new edition, 3rd, of IEC 60950. But, it does bring up the question of when the EN, UL/CSA versions will be issued. Anyone have the proposed dates? Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: barry marks [mailto:bma...@activepower.com] Sent: Friday, January 14, 2000 2:20 PM To: 'Ned Devine'; emc-p...@majordomo.ieee.org Subject: RE: Capacitors to Ground Ned, Interesting, my copy of EN60950 (covers through A4) doesn't have the part about the y caps, it only addresses X cap applications in 1.5.6. Y capacitors are referenced in 1.6.4, but that clause is specifically for IT power systems, which our equipment will not function on. What version of EN60950 did you quote that from? Thanks, Barry Marks -Original Message- From: owner-emc-p...@ieee.org [mailto:owner-emc-p...@ieee.org]On Behalf Of Ned Devine Sent: Friday, January 14, 2000 9:49 AM To: emc-p...@majordomo.ieee.org Subject: RE: Capacitors to Ground Hi, You might be in trouble, Clause 1.5.6 of IEC 60950, 3rd edition requires Y. See Clause below. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com 1.5.6 Capacitors in primary circuits A capacitor connected between two line conductors of the PRIMARY CIRCUIT, or between one line conductor and the neutral conductor, shall comply with IEC 60384-14:1993, subclass X1 or X2. The duration of the damp heat, steady state test as specified in 4.12 of IEC 60384-14:1993 shall be 21 days. A capacitor connected between the PRIMARY CIRCUIT and protective earth shall comply with of IEC 60384-14:1993, subclass Y1, Y2 or Y4, as applicable. NOTE - The above requirement does not apply to capacitors connected from a HAZARDOUS VOLTAGE SECONDARY CIRCUIT to earth. For such capacitors, the electric strength test of 5.2.2 is considered sufficient. Compliance is checked by inspection. -Original Message- From: BarryM [mailto:bar...@spaceship.com] Sent: Thursday, January 13, 2000 2:03 PM To: emc-p...@majordomo.ieee.org Subject: Capactitors to Ground Hello all, I'm looking for any standards / decisions / interpretations, etc... that discuss the use of capacitors to ground in industrial, fixed, permanently connected equipment. We have a 3 phase, 400V product that requires a significant amount of capacitance to ground, and the use of available Y rated capacitors is burdensome in that it would take a lot of them. We're aware of leakage current issues, and are well within the 5% allowance (EN50091-1-1, which references EN60950 for most core requirements). We are using about 1.3-2uf from each phase to ground. UL and CSA both do not require y type capacitors in this class of product, I'm hoping there is a similar rationale in Europe. Thank you in advance for any comments you may have, Barry Marks
RE: Capacitors to Ground
Hi, You might be in trouble, Clause 1.5.6 of IEC 60950, 3rd edition requires Y. See Clause below. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com 1.5.6 Capacitors in primary circuits A capacitor connected between two line conductors of the PRIMARY CIRCUIT, or between one line conductor and the neutral conductor, shall comply with IEC 60384-14:1993, subclass X1 or X2. The duration of the damp heat, steady state test as specified in 4.12 of IEC 60384-14:1993 shall be 21 days. A capacitor connected between the PRIMARY CIRCUIT and protective earth shall comply with of IEC 60384-14:1993, subclass Y1, Y2 or Y4, as applicable. NOTE - The above requirement does not apply to capacitors connected from a HAZARDOUS VOLTAGE SECONDARY CIRCUIT to earth. For such capacitors, the electric strength test of 5.2.2 is considered sufficient. Compliance is checked by inspection. -Original Message- From: BarryM [mailto:bar...@spaceship.com] Sent: Thursday, January 13, 2000 2:03 PM To: emc-p...@majordomo.ieee.org Subject: Capactitors to Ground Hello all, I'm looking for any standards / decisions / interpretations, etc... that discuss the use of capacitors to ground in industrial, fixed, permanently connected equipment. We have a 3 phase, 400V product that requires a significant amount of capacitance to ground, and the use of available Y rated capacitors is burdensome in that it would take a lot of them. We're aware of leakage current issues, and are well within the 5% allowance (EN50091-1-1, which references EN60950 for most core requirements). We are using about 1.3-2uf from each phase to ground. UL and CSA both do not require y type capacitors in this class of product, I'm hoping there is a similar rationale in Europe. Thank you in advance for any comments you may have, Barry Marks
RE: Pollution degree help
Hi, Yes, you need three or more layers of pre-preg in between the SELV and MAINS traces. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Andrews, Kurt [mailto:kandr...@tracewell.com] Sent: Tuesday, January 11, 2000 2:04 PM To: Ned Devine; 'emc-p...@ieee.org' Subject: RE: Pollution degree help Ned, You wrote: For example, you can have SELV over Mains if you have three or more layers of pre-preg. You also would not have to do any type or routine testing. Does this mean 3 layers in between the SELV and the Mains layers i.e. Mains-layer of pre-preg-layer of pre-preg-layer of pre-preg-SELV? I sure have learned a lot from this group since I moved into compliance almost 2 years ago. Kurt Andrews Compliance Engineer Tracewell Systems, Inc. 567 Enterprise Dr. Westerville, OH 43081 Ph. 614-846-6175 Fax 614-846-7791 Email: kandr...@tracewell.com -Original Message- From: Ned Devine [SMTP:ndev...@entela.com] Sent: Tuesday, January 11, 2000 10:02 AM To: 'emc-p...@ieee.org' Subject:RE: Pollution degree help Hi, Be careful. Through insulation does not necessary mean 0.4 mm. It can be thin sheet material. See UL 1950, Table 6A and IEC 60950, 3rd edition, Table 2M for requirements for printed wiring boards. For example, you can have SELV over Mains if you have three or more layers of per-preg. You also would not have to do any type or routine testing. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Andrews, Kurt [mailto:kandr...@tracewell.com] Sent: Tuesday, January 11, 2000 9:29 AM To: Ned Devine; 'emc-p...@ieee.org' Subject: RE: Pollution degree help Ned and emc-pstc'ers, After reading the clauses you mentioned it appears that the UL Engineer was a little off base. You are correct that internal PCB layers can be treated as distance through insulation. In fact both standards specifically state that internal PCB layers are done this way (you learn something new every day!). That makes it real nice as that means there is no minimum requirement for distance between these internal tracks except when supplementary or reinforced insulation is required. However, I would say that the UL Engineer is correct about the statement about not having SELV directly above or below AC. If the SELV is not earthed the requirements call for reinforced insulation between the SELV circuit and the Primaries and this would necessitate the use of the 0.4mm separation distance. The same is true from a TNV circuit to a Primary circuit. This separation would be difficult to achieve unless there were some intervening layers. Kurt Andrews Compliance Engineer Tracewell Systems, Inc. 567 Enterprise Dr. Westerville, OH 43081 Ph. 614-846-6175 Fax 614-846-7791 Email: kandr...@tracewell.com -Original Message- From: Ned Devine [SMTP:ndev...@entela.com] Sent: Monday, January 10, 2000 1:21 PM To: 'emc-p...@ieee.org' Subject:RE: Pollution degree help Hi, Very interesting. UL 1950, Clause 2.9.6 and IEC 60950, 3rd edition, Clause 2.10.5.3 both state that the distance between two adjacent tracks on the same layer of a PCB is treated as distance through insulation. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Andrews, Kurt [mailto:kandr...@tracewell.com] Sent: Monday, January 10, 2000 12:14 PM To: Price, Ed; 'emc-p...@ieee.org' Cc: 'Chris Wells' Subject: RE: Pollution degree help Ed, Chris, Normally Pollution Degree 1 is used for items that receive no pollution at all. These are hermetically sealed or potted/encapsulated parts. However you can use pollution degree 1 for internal PCB layers. You can also reduce the spacings below what is required by the creepage and clearance charts in UL 1950 if the proper dielectric strength tests are performed. Bear in mind that this only applies to Information Technology Equipment i.e. UL 1950
RE: Pollution degree help
Hi, Be careful. Through insulation does not necessary mean 0.4 mm. It can be thin sheet material. See UL 1950, Table 6A and IEC 60950, 3rd edition, Table 2M for requirements for printed wiring boards. For example, you can have SELV over Mains if you have three or more layers of per-preg. You also would not have to do any type or routine testing. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Andrews, Kurt [mailto:kandr...@tracewell.com] Sent: Tuesday, January 11, 2000 9:29 AM To: Ned Devine; 'emc-p...@ieee.org' Subject: RE: Pollution degree help Ned and emc-pstc'ers, After reading the clauses you mentioned it appears that the UL Engineer was a little off base. You are correct that internal PCB layers can be treated as distance through insulation. In fact both standards specifically state that internal PCB layers are done this way (you learn something new every day!). That makes it real nice as that means there is no minimum requirement for distance between these internal tracks except when supplementary or reinforced insulation is required. However, I would say that the UL Engineer is correct about the statement about not having SELV directly above or below AC. If the SELV is not earthed the requirements call for reinforced insulation between the SELV circuit and the Primaries and this would necessitate the use of the 0.4mm separation distance. The same is true from a TNV circuit to a Primary circuit. This separation would be difficult to achieve unless there were some intervening layers. Kurt Andrews Compliance Engineer Tracewell Systems, Inc. 567 Enterprise Dr. Westerville, OH 43081 Ph. 614-846-6175 Fax 614-846-7791 Email: kandr...@tracewell.com -Original Message- From: Ned Devine [SMTP:ndev...@entela.com] Sent: Monday, January 10, 2000 1:21 PM To: 'emc-p...@ieee.org' Subject:RE: Pollution degree help Hi, Very interesting. UL 1950, Clause 2.9.6 and IEC 60950, 3rd edition, Clause 2.10.5.3 both state that the distance between two adjacent tracks on the same layer of a PCB is treated as distance through insulation. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Andrews, Kurt [mailto:kandr...@tracewell.com] Sent: Monday, January 10, 2000 12:14 PM To: Price, Ed; 'emc-p...@ieee.org' Cc: 'Chris Wells' Subject: RE: Pollution degree help Ed, Chris, Normally Pollution Degree 1 is used for items that receive no pollution at all. These are hermetically sealed or potted/encapsulated parts. However you can use pollution degree 1 for internal PCB layers. You can also reduce the spacings below what is required by the creepage and clearance charts in UL 1950 if the proper dielectric strength tests are performed. Bear in mind that this only applies to Information Technology Equipment i.e. UL 1950, IEC 60950, EN 60950, etc. Other standards may treat this subject differently. I asked the following question about internal PCB layers of a UL engineer a few months back. See below my question and his response: Question: We would like to design a multi-layer PC Board with the AC Primary Section on one of the internal layers. As far as spacings between the AC traces go, can we use the requirements for Pollution Degree 1 products? I would assume that an internal layer on a PCB would be classified as Pollution Degree 1 since it is completely protected from the environment. I do realize that where the traces are also on an external layer i.e. where the input and/or output connectors are located, that we would need the spacings required for Pollution Degree 2. Also, am I correct in assuming that we can reduce the spacings even further if we do the appropriate electric strength tests of section 5.3.2? Also, is this requirement just a type test or is it also a production test? Answer: You are correct in your assessment. A completely internal layer is pollution degree 1. Operational spacings may be reduced if type-testing is done on the electric strength of the insulation. Warning, if you have SELV above or below the AC trace, some European agencies won't accept it or will require extensive testing of your PWB. Hope this helps, Kurt Andrews Compliance Engineer Tracewell Systems, Inc. 567 Enterprise Dr. Westerville, OH 43081 Ph. 614-846-6175 Fax 614-846-7791 Email: kandr...@tracewell.com -Original Message
RE: Pollution degree help
Hi, Very interesting. UL 1950, Clause 2.9.6 and IEC 60950, 3rd edition, Clause 2.10.5.3 both state that the distance between two adjacent tracks on the same layer of a PCB is treated as distance through insulation. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Andrews, Kurt [mailto:kandr...@tracewell.com] Sent: Monday, January 10, 2000 12:14 PM To: Price, Ed; 'emc-p...@ieee.org' Cc: 'Chris Wells' Subject: RE: Pollution degree help Ed, Chris, Normally Pollution Degree 1 is used for items that receive no pollution at all. These are hermetically sealed or potted/encapsulated parts. However you can use pollution degree 1 for internal PCB layers. You can also reduce the spacings below what is required by the creepage and clearance charts in UL 1950 if the proper dielectric strength tests are performed. Bear in mind that this only applies to Information Technology Equipment i.e. UL 1950, IEC 60950, EN 60950, etc. Other standards may treat this subject differently. I asked the following question about internal PCB layers of a UL engineer a few months back. See below my question and his response: Question: We would like to design a multi-layer PC Board with the AC Primary Section on one of the internal layers. As far as spacings between the AC traces go, can we use the requirements for Pollution Degree 1 products? I would assume that an internal layer on a PCB would be classified as Pollution Degree 1 since it is completely protected from the environment. I do realize that where the traces are also on an external layer i.e. where the input and/or output connectors are located, that we would need the spacings required for Pollution Degree 2. Also, am I correct in assuming that we can reduce the spacings even further if we do the appropriate electric strength tests of section 5.3.2? Also, is this requirement just a type test or is it also a production test? Answer: You are correct in your assessment. A completely internal layer is pollution degree 1. Operational spacings may be reduced if type-testing is done on the electric strength of the insulation. Warning, if you have SELV above or below the AC trace, some European agencies won't accept it or will require extensive testing of your PWB. Hope this helps, Kurt Andrews Compliance Engineer Tracewell Systems, Inc. 567 Enterprise Dr. Westerville, OH 43081 Ph. 614-846-6175 Fax 614-846-7791 Email: kandr...@tracewell.com -Original Message- From: Price, Ed [SMTP:ed.pr...@cubic.com] Sent: Monday, January 10, 2000 9:48 AM To: 'emc-p...@ieee.org' Cc: 'Chris Wells' Subject:FW: Pollution degree help Posted for Chris Wells [cdwe...@stargate.net] -Original Message- From: Chris Wells [SMTP:cdwe...@stargate.net] Sent: Sunday, January 09, 2000 9:36 AM To: 'emc-pstc' Subject: Pollution degree help What Pollution degree should I be using for PCBs and why? I have taken several products through the CE LVD evaluation (EM61010-1) and typically claim pollution degree II on our PCBs. Recently this has been challenged by other engineering groups at our location who would like to use smaller spacings. They believe we can use pollution degree I and I find this impractical.. I would very much appreciate any information that would help me make or break my case of sticking with pollution degree II. Details: Our group designs industrial electronics used in power meters and protective relays. I believe our latest housings would be considered IP 50. Some earlier products may not have as effective dust protection. We typically call out an external product environment of pollution degree II. These products are typically mounted into the sheet metal front of automation or power distribution gear. Our specifications claim a non condensing environment but it would be inaccurate to claim that it never happens. The majority of our Printed Circuit Boards (PCBs) except connectors and areas that get hot are coated with an acrylic conformal coating. The connectors may have a lubricant but is not a dust seal. Question(s) Are there some good references or url you can share that would expand upon the logic for applying pollution degree? I have read IEC664 and IEC 539 ( these reference #s are from memory) and could use some good examples now. The feedback I have gotten so far puts pollution degree I as a very controlled environment like a clean room or perhaps an office environment. My understanding of an industrial environment is that it is typically
RE: Notified Bodies
Hi, I don't see any reason why not. I think you can even ask for an official opinion on the same subject from two different NB. The only rule I know of is that you can not make application to two Notified Bodies for the same device (i.e. MDD, Annex III, paragraph 2, third -) or quality system (i.e. MDD, Annex II, paragraph 3.1, third -). I am assuming that the other directives have a similar requirement. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: wo...@sensormatic.com [mailto:wo...@sensormatic.com] Sent: Thursday, December 16, 1999 2:42 PM To: emc-p...@majordomo.ieee.org Subject: Notified Bodies Is it allowed to obtain an official opinion from a Notified Body on one particular issue and obtain an official opinion from a second Notified Body on a different issue where the issues are not related? Richard Woods - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
Measuring ESD
Hello, I need some help from the ESD experts. I am trying to find a way to measure the electro-static build-up on a hand operated pump. The device is used to suck out the gas from small gas engines before the service. Obviously, an ESD event would not be a good thing. We are trying to validate some design concepts for the customer. The pump is a piston type. It sort of looks like a giant syringe with a one way valve. The pump has integral threads and is screwed to a large 2-3 gallon plastic tank. The pump is used to create a vacuum in the tank. You need to pump, really pull, it 10-15 times to get the necessary vacuum. A siphon hose is attached to the tank. You open a clamp on the hose to suck the gas into the container. I think I need a static monitor or field meter. Does anyone have any ideas on test equipment or test methods? I did a search and I came up with John Chubb Instrumentation, model JCI 140 Static Monitor. Does anyone have any experiences with this meter or others? Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: NRTL acceptance
Hi, For a list of Accredited certification organizations go to http://www.scc.ca/certific/colist.html For the scope of Accredited certification organizations go to http://www.scc.ca/search-front/indexacc.html Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com PS Yes, Entela is a CO. -Original Message- From: geor...@lexmark.com [mailto:geor...@lexmark.com] Sent: Tuesday, November 23, 1999 8:02 AM To: emc-p...@majordomo.ieee.org Subject: RE: NRTL acceptance S. William, Thanks for the words on COs and TOs and SCCs. Apparantly UL is one or more of these, as the c-UL mark is legally acceptable in Canada. Now, what other COs has the SCC accredited to issue an approved Canadian mark? Not CSA, but alternatives to CSA? George -- Forwarded by George Alspaugh/Lex/Lexmark on 11/23/99 07:57 AM --- swilliam%apcc@interlock.lexmark.com on 11/22/99 05:02:15 PM To: George_Alspaugh/Lex/Lexmark@LEXMARK cc: emc-pstc%majordomo.ieee@interlock.lexmark.com (bcc: George Alspaugh/Lex/Lexmark) Subject: RE: NRTL acceptance George, Canada is not as straight forward as that. There is not a mutual agreement. In order for a lab to issue a Canadian Approval Mark, the lab must be accredited as a CO(Certifying Organization) by the SCC(Standards Council of Canada). The CO must use data that has come from a TO(Testing Organization) that is also accredited by the SCC. Most labs that issue their Canada Mark are both a CO and TO so it is very easy for them. The critical item is that the product has to have been tested against the relevant Canadian National Standard(very easy for ITE as 1950 is a joint standard). If you want to do everything by the book, your US Mark should be from an NRTL certified by OSHA to the standards that apply to your product and the Canadian Mark must be from a CO accredited by the SCC. Please respond to geor...@lexmark.com To: emc-p...@majordomo.ieee.org cc:(bcc: Steve Williams/SDD/NAM/APCC) From: geor...@lexmark.com on 11/22/99 03:42 PM Subject: RE: NRTL acceptance I tried to recall NRTLs that were approved for asessments of ITE to UL1950. I did not overlook MET (listed in my note), but may have missed NTS which may fit this description. I'm not sure the others are sanctioned for listing of ITE under UL1950. There are many NTRLs, including UL. There is no NRTL mark, as all NRTLs are legally equal. The mark of some NRTLs has included the letters NRTL as part of their mark, apparantly by choice. The CSA/NRTL mark is an example. To my knowledge, the use of NRTL in an agency's mark is not mandatory. CSA has recently changed their mark to drop the NRTL and simply show the CSA mark with US subscript for assessment to the U.S. stadnard. However, Canada does not recognize the U.S. NRTLs to assess an ITE product to the Canadian standard. There is a mutual agreement between Canada and the U.S. that allows a UL assessment to the Canadian ITE safety standard. This results in the UL mark with a subscript C, often called the c-UL mark. It is my understanding that when the Canadian government bids out ITE for its own use, they tend to prefer the CSA mark over the c-UL mark. This seems to violate the spirit of the agreement, but who can force them to do otherwise? George Alspaugh (Some or all of the above may reveal ignorance on my part, which can be cured by more enlightened appends to follow.) - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Shielded Enclosure Fire Hazard
Hello, Put the sprinklers in. Also, make sure they are 360 deg (i.e. spray up and down) heads!!. At a previous employer, we had a fire in a cone lined, shield room. We had sprinklers, but they were only 180 deg. (i.e. down). The fire started when some cones on the ceiling came loose and came into contact with a spot light. The fire smoldered for quite some time, before the sprinklers went off. This forced the smoke out the vent holes in the bottom of the room. That is when we noticed the fire. Because the sprinklers were below the cones and did not spray up, the cones just keeps on burning. The fire went up and out the top ventilation opening and into the building ceiling. At about this time, the fire department showed up and put the fire out. As with most fires, the majority of damage was from the water and the smoke. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Price, Ed [mailto:ed.pr...@cubic.com] Sent: Tuesday, November 16, 1999 9:22 PM To: 'emc-p...@ieee.org' Subject: Shielded Enclosure Fire Hazard Hi Listmembers! My lab just had an annual inspection visit by our friendly fire hazard inspector. Seems that after 4 successive years of inspections, I suddenly failed this year. The reason is that my 24' x 35' x 10' modular shielded enclosure doesn't have internal water sprinklers. Now I'm all in favor of sprinklers; there's several in the ceiling of the parent room that contains my enclosure. But that doesn't protect the contents of the shielded enclosure. What if a fire started inside the enclosure and then had time to grow? The parent room sprinklers might not be able to stop the blaze then! Never mind that there's almost no fuel within the enclosure; just fire-retardant rated anechoic foam and a 10' long table made out of wood 4x4's. So I don't suppose this is really about common sense. Has anyone recently addressed the issue of fire protection within a shielded enclosure? Or should I move right on to the sprinkler RFQ phase? Regards, Ed :-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-) Ed Price ed.pr...@cubic.com Electromagnetic Compatibility Lab Cubic Defense Systems San Diego, CA. USA 619-505-2780 (Voice) 619-505-1502 (Fax) Military Avionics EMC Services Is Our Specialty Shake-Bake-Shock - Metrology - Reliability Analysis :-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-) - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Permanence of marking test.
Hi, I asked our Chemist and he gets it from Aldrich. We have one liter bottles. Aldrich 1001 West Saint Paul Avenue Milwaukee, WI 53233 Mail: P. O. Box 355 Milwaukee, WI 53201 U.S.A. Phone: (414) 273-3850 Fax: (414) 273-4979 Order: 800-558-9160; Fax 800-962-9591 Customer Service: 800-558-9160; Fax 800-962-9591 Technical Service: 800-231-8327; Fax (414) 287-4079 E-Mail: aldr...@sial.com Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Ehler, Kyle [mailto:kyle.eh...@lsil.com] Sent: Wednesday, October 27, 1999 4:04 PM To: EMC and Safety list Subject: Permanence of marking test. I'm sorry to plague the list with such a mundane query, but I am forced to perform the UL1950 '1.7.15 Permanence of Marking' test using HEXANE as the test solvent. I cannot find a local source willing to sell less than 55Gal 0.5L would probably last me ten years. Anybody know of a source? Kyle Ehler kyle.eh...@lsil.com mailto:kyle.eh...@lsil.com Assistant Design Engineer LSI Logic Corporation 3718 N. Rock Road U.S.A. Wichita, Kansas 67226 Ph. 316 636 8657 Fax 316 636 8889 Fax 316 636 8315 - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Temperature probe
Hi, I would think a thermocouple would be OK. It should be close to +/- 1 deg. C. If you need better accuracy, try a RTD. It should be +/- 0.1 deg. C. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Leslie Bai [mailto:leslie_...@yahoo.com] Sent: Wednesday, October 06, 1999 2:29 PM To: emc-p...@ieee.org Subject: Temperature probe Hello, group: Seems that my question is not relavent to this group but hope someone there could help. I am looking for an ACCURATE temperature probe ( accuracy is about +/- 1 degree C from -50 to +80 degree C). It will be used to measure the microwave frequency drifting over the temperature. It will be put in a temperature chamber. Although the chamber has a temeprature display, it's not accurate as we expected (about +/-3 degree C), thus we need a more accurate probe to perform the measurement. If you have any info or similiar probe, pls kindly let me know - the brand, model, etc... Thanks in advance. Leslie http://biz.yahoo.com/prnews/991006/ca_digit_m_1.html = __ Do You Yahoo!? Bid and sell for free at http://auctions.yahoo.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Screen Dimensions - Fire Enclosures
Hi, See Annex A.5, Hot Flaming Oil test. I have never done this test, but I have the ladle. Good luck. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: John Juhasz [ mailto:jjuh...@fiberoptions.com mailto:jjuh...@fiberoptions.com ] Sent: Monday, October 04, 1999 10:39 AM To: 'emc-p...@majordomo.ieee.org' mailto:'emc-p...@majordomo.ieee.org' Subject: Screen Dimensions - Fire Enclosures Hi group. With reference to UL 1950 3rd. Ed., Table 15 (size and spacing of holes in metal bottoms of fire enclosures) , I would like some opinions . . . the largest size listed in the table is 1.00mm minimum metal thickness, 2.00mm maxhole dia., and 3.00mm minimum center-center hole spacing. If my metal thickness was greater (1.27mm), and my center-center hole spacing was 4.75mm, could I not go to a larger hole (3.175 - .125)? The reason I pose this question is that the dmensions I was thinking about using are for a 'standard' punch that a sheet metal fabricator would have. UL told me that what's they won't consider it because it's not listed on the chart. I am trying to tell my mechanical designer to use standard perforated stock which falls within the UL guidelines (there is stuff readily available) but he needs more airflow (without fans) . . . Has anyone been there? John Juhasz Fiber Options Bohemia, NY - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Ground Bond Testers
Hello, This is what we use. We have a number of power supplies from 50 amps to 1000 amps. We use a calibrated current shunt to verify the output current. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: peterh...@aol.com [mailto:peterh...@aol.com] Sent: Saturday, September 11, 1999 2:02 PM To: bkundew...@qtm.net; emc-p...@ieee.org Subject: Re: Ground Bond Testers Brian, I think that you would be able to use a bench type DC power supply which is cable of delivering 100A at low voltage of 12V. Standard does specify AC or DC current. This way, you don't have to have an specific ground tester. Almost all companies have DC power supply that can be used for these type of applications. Perhaps others could express their view on the use of DC power supply. Thanks Peter - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Insulation resistance
Hi, That reference is to the old CB Bulletin 89AI, page 117. It has been superseded by CB Bulletin, 94AI, page 108. That deviation has been removed. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Ehler, Kyle [mailto:kyle.eh...@lsil.com] Sent: Friday, September 10, 1999 11:49 AM To: emc-p...@majordomo.ieee.org Subject: Insulation resistance I just received an amended CB report for a product we make and I was reviewing it and see that a 'fail' verdict was given for a deviation + test in Sub-Clause 5.3.101 of the Japanese deviation to IEC 950. A remark of Not evaluated as part of this investigation also appears. The text of the Deviation + Test reads: Add: The insulation resistance shall comply with the requirements of Clauses 16.3 of IEC Publication 335-1 (1976) Second Edition. I use UL1950 2nd and 3Rd ed. and I cannot find this 5.3.101 reference in the latest copy of the standard, much less IEC Pub 335-1. If a customer put me on the spot for this, I might need to test for it... Can someone educate me on this? Thank You. Kyle Ehler kyle.eh...@lsil.com mailto:kyle.eh...@lsil.com Assistant Design Engineer LSI Logic Corporation - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Medical Equipment Question; Voltage Limits for Handheld and F oot-Operated Controls
Hi, See below for answers to your questions. In summary, IEC 60601-1, Clause 56.11 does not allow this type if construction. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com Dear All, One of the sections in the medical equipment standard (IEC 601-1) requires that handheld and foot-operated control devices and their cables be in circuits not more than 25 Vac or 60 Vdc or peak value separated from the mains by an acceptable method as specified in the standard. Question: Does this requirement apply to a a hand-held applied part with push-button switches supplying high voltages to the patient? Answer: Yes. This type of construction is not allowed. Question: Are the limits 25 Vac or (60 Vdc or 60 Vpeak)? Answer: Yes. The limits are the SELV limits for medical equipment. See Clause 2.4.3. Question: Are the limits 25 Vac OR 60 Vdc OR any peak value if separated from the mains by an acceptable method? Answer: No. Question: What is the rationale behind the requirement? Why can't someone have a 230 V rated foot-operated device which fully complies with the requirements or have a 1000 V applied part complying with the requirements? Answer: Don't know. My guess is that they did not want to take the chance of someone inadvertently using a SELV control on a mains circuit. Regards, PETER S. MERGUERIAN MANAGING DIRECTOR PRODUCT TESTING DIVISION I.T.L. (PRODUCT TESTING) LTD. HACHAROSHET 26, P.O.B. 211 OR YEHUDA 60251, ISRAEL TEL: 972-3-5339022 FAX: 972-3-5339019 E-MAIL: pe...@itl.co.il Visit our Website: http://www.itl.co.il - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Record Retention
Hi, The guidelines on the LVD state that the documentation has to be kept for at least ten years from the last date of manufacture of the product. Other Directives talk about the lifetime of the unit but not less than 5 years. I guess the answer depends on what is longer. 10 years or the lifetime of the product. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com -Original Message- From: Ehler, Kyle [mailto:kyle.eh...@lsil.com] Sent: Thursday, July 22, 1999 2:32 PM To: Scott Douglas; 'EMC-PSTC' Subject: RE: Record Retention Hi Scott, A while back I inquired with TUV, UL and FCC about this very subject. UL and TUV is pretty loose about manufacturer's recordkeeping of production run information, but product safety test data and related filing information is expected to be retained for at least seven years after last production date according to Kevin Hyland (x42652), the RROP for ITE records at the Northbrook office of UL (847 272 8800). For factory records, the point is fairly moot as long as a FUS program is in place with quarterly inspections conducted which include dielectric and ground bond procedures on %100 of production and test equipment start of day checks. The FCC wants records maintained the same period or longer, but since the two are closely related to agency compliance, archiving both EMC and Safety data in one place is just good business practice. Our lab is in process of getting all but originals into electronic form and packing it onto CD-Roms. A dollar a CD-R is a lot less than a zip disk... Incidentally, UL still maintains records from their first inception. They reportedly have product records over 100 years old. I was investigating this on a proactive basis in efforts to prod our factory into keeping more detailed records. The data could be useful in tracking break-ins of changes to the manufacturing process in event of a call-back. This would make the task of tracing thousands of products in the field as simple as associating the serial number list with the customer shipping list. The effort was like pushing a rope uphill -I failed anyway. Kyle Ehler kyle.eh...@lsil.com mailto:kyle.eh...@lsil.com Ass. Design Engineer LSI Logic Storage Systems Division 3718 N. Rock Road U.S.A. Wichita, Kansas 67226 Ph. 316 636 8657 Fax 316 636 8889 Fax 316 636 8315 Kyle Ehler kyle.eh...@lsil.com mailto:kyle.eh...@lsil.com Design Engineer LSI Logic Storage Systems Division 3718 N. Rock Road U.S.A. Wichita, Kansas 67226 Ph. 316 636 8657 Fax 316 636 8889 Fax 316 636 8315 -Original Message- From: Scott Douglas [SMTP:s_doug...@ecrm.com] Sent: Thursday, July 22, 1999 8:35 AM To: 'EMC-PSTC' Subject:Record Retention I have a question about record retention. We make ITE which incorporates lasers and certify to LVD, EMC directives. We do not create a TCF specifically. We do have outside lab test reports for safety and for EMC. We also have the usual parts lists and CAD drawings for fabrication and assembly along with test procedures. We do record all production tests required for each product shipped. What documents do we need to keep and how long do we need to keep them? We keep the form where we record production tests required for compliance (hipot, ground continuity, laser safety, etc.) for ten years. What engineering drawings, parts lists, test procedures, etc. do we need to keep and for how long? Can anyone point me to a specific reference that requires this? Thank you in advance for your comments. Scott s_doug...@ecrm.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
fire extinguishers for boats
Hi, Does anyone know what is the directive for fire extinguishers. I checked the simple pressure vessel directive, but it excludes fire extinguishers. If it make any difference, this particular fire extinguisher is for use in the engine compartment of a boat. Thanks Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
Clause 4.3.18 of IEC 950
Hello, I am having a discussion with a colleague about Clause 4.3.18 of IEC 950. This clause is for direct plug-in equipment. The clause states ...at a distance of 8 mm behind the engagement face of the socket-outlet. The discussion is on what is meant by behind. Does it mean towards the end of the blades or towards the body of the plug-in? Also, is the engagement face where the blades enter the body or where the body rests on the wall. For North America this is the same, but for some European outlets there is a difference. Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail ndev...@entela.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
Thermostats
Hi, I am currently working on a pizza warming tray that uses a resistive heating element, a thermostat and a thermal cut-off. They are getting a large number of returns due to the thermal cut-off opening. There is no hazard, the thermal cut-off is doing its job. The questions I have are on the thermostat. 1. The manufacture states a 2% failure rate is normal. This seems high to me. Can anyone verify this or recommend a better manufacture. The load is 120 V, 220 Watts. Temperature range 90 to 100 deg. C. 2. What is the failure mode for thermostats? Is it likely for a thermostat to get stuck in the closed position and then start working? Maybe after being subjected to a mechnical shock? The ones I have checked seem to be working. e.g. are in the normally closed position and when heated open and then close when cooled. Ned Devine ndev...@entela.com Phone 616 248 9671 Fax 616 - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: question (re: 98/37/EC
Hi, The Machinery Directive (and many others) was amended by the CE marking directive 93/68/EEC (OJ L220, 8/30/93, page 8) to remove the year of manufacture from the CE marking. The same Directive also amended, Annex I, Clause 1.7.3 to require - the year of construction. to be on the unit. Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 574 9752 e-mail: ndev...@entela.com -Original Message- From: George, David L [mailto:george.da...@unisys.com] Sent: Wednesday, November 25, 1998 10:39 AM To: emc-p...@majordomo.ieee.org Cc: lisa_cef...@mksinst.com Subject: RE: question (re: 98/37/EC Lisa: There seems to be one difference. Can anyone verify how the date code is to be displayed? As in the old directive, Directive 98/37/EC requires the use of the year of manufacture. The old Directive indicated the year of manufacture should be a part of the CE mark, The new Directive appears to specify the year of manufacture is to placed on the product label. Does anyone have information about where the year is to be indicated and what happened to the year with the CE mark? Dave George Unisys -Original Message- From: Art Michael [mailto:amich...@connix.com] Sent: Tuesday, November 24, 1998 4:32 PM To: emc-p...@majordomo.ieee.org Cc: lisa_cef...@mksinst.com Subject:question (re: 98/37/EC Hello Lisa, 98/37/EC is a re-issue of the original Machinery Directive (89/392/EEC) along with all of its amendments to that re-issue. 98/37/EC can be found in the EC's Official Journal (OJ, L 207, pages 1-46, dated 23 July 1998. Regards, Art Michael, Editor - Int'l Product Safety News * * * * * * * * * * * * * * * * * * * * * * * International Product Safety Bookshop * * Check out our current offerings! * * http://www.safetylink.com/bookshop.html * * A new service of the Safety Link * * * * * * * * * * * * * * * * * * * * * * * - On Tue, 24 Nov 1998 lisa_cef...@mksinst.com wrote: Can someone confirm for me that the machinery Directive is now 98/37/EC? ..or is this an ammendment to the original? - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: The regulatory effect of distribution strategies
Hi Chris, 1. In this scenario where we only ship software and part of the hardware what are our regulatory responsibilities vs. those of the distributor? Answer: Based on the Medical Device Directive, Article 1, paragraph 2.(a), software is included in the definition of a medical device. If your name is on the software and/or hardware you are considered the manufacture and must comply with the MDD. 2. Need we simply ensure the components of our system which we supply to the distributor are CE marked OR should we assemble a complete representative system as it will be marketed in the EU and perform all relevant type testing ourselves? Answer: Most likely you will need to assemble a system. Article 12, paragraph 2 covers this. See below 2. Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration by which he states that: (a) he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions; and (b) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and (c) the whole activity is subjected to appropriate methods of internal control and inspection. Where the conditions above are not met, as in cases where the system or procedure pack incorporate devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a device in its own right and as such be subjected to the relevant procedure pursuant to Article 11. 3. If we need only CE mark the components we ship -- Is software typically CE marked? Where does one look for the essential requirements for software? Answer: Software is typically CE marked. Even if the software is distributed over the Internet, it still needs to meet the requirements of the MDD and be marked (e.g. included in the electronic manual). See Annex I for the ER. 4. If we are only supplying part of the total system (the software and pager) yet the system design and specifications are ours, are we still considered the manufacturer under the medical device directive? Answer: Article 1, paragraph 2.(f) defines the manufacturer (see below). Basically, if you name is on the device, you are the manufacturer. (f) 'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient; 5. If the distributor places their name on the product, (and assumes all responsibilities except design) do they become the manufacturer? Answer: If you name is not on the unit, you are not the manufacture and have no responsibilities under the MDD. Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 574 9752 e-mail: ndev...@entela.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: LED Reqs under A11 to EN60950
Hi, At a former employer (EU Notified Body based in Germany), we were told to ignore normal LED's, unless when looking into them they looked Dazzling. The rational was that the requirement was going to be changed to exempt them and there was no sense in enforcing it. Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 574 9752 e-mail: ndev...@entela.com -Original Message- From: Crabb, John [mailto:jo...@exchange.scotland.ncr.com] Sent: Friday, November 20, 1998 4:26 AM To: 'Frank West'; 'EMC-PSTC Mailing List' Subject: RE: LED Reqs under A11 to EN60950 I would also be interested to know what everyone is doing (or not doing !!). As far as I can gather, everyone is ignoring this issue, as it is just so ridiculous. After all, the only way you can prove that a LED is Class 1 or below is to do the measurements - and I'm sure most of us don't have the equipment to do this. (or the time, or the inclination). John Crabb, Product Safety Engineer, NCR Financial Solutions Group Ltd, Dundee, Scotland. - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
telecommunications terminal equipment
Hi, I am looking for labs that can perform some or all of the testing required per the telecommunications terminal equipment directive. Please respond to me. Thanks Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 574 9752 e-mail: ndev...@entela.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
Energized Winging Tester
Hi, I am in the market for an energized winding tester. I use to buy the AVO/Biddle Energized Winging Tester, but it is no longer being produced. Does anyone have any recommendation's? Has anyone built one? Ideally, I would like one that would record the resistance instead of an integral wheatstone bridge like the Biddle. Thanks Ned Devine Entela, Inc. Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 574 9752 e-mail: ndev...@entela.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
Shock and Vibration
Hello, I am trying to determine what shock and vibration testing to do for a piece of medical equipment. The equipment is an EKG. It is basically a personal computer that is placed on a cart. The cart would be moved from room to room, but would not be removed from the cart. I am NOT concerned with shock and vibration during shipping, just during use. What, if anything, do PC makers do for operational vibration? Any help would be appreciated. Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 574 9752 e-mail: ndev...@entela.com - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Computer simulation of the IEC1000-4-5 surge waveform
Hi, No. The 4th amendment to IEC 950 has circuits and component values for the 10/700 and 1.2/50 impulses. Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 574 9752 e-mail: ndev...@entela.com -- From: plaw...@west.net[SMTP:plaw...@west.net] Reply To: plaw...@west.net Sent: Tuesday, September 08, 1998 11:32 AM To: emc-p...@majordomo.ieee.org Subject: Re: Computer simulation of the IEC1000-4-5 surge waveform On Fri, 4 Sep 1998 15:59:34 -0400 , Ned Devine ndev...@entela.com wrote: The 1.2/50 us impulse circuit is described in IEC 950, 4 th Amendment, Annex N. It has values for the components. If you don't have the standard, give me a call. I have the UL version of 950 (3rd edition), and the only surge circuit described is the 10us/700us (also Annex N). Is that the same situation with IEC950 4th Amendment? -- Patrick Lawler plaw...@west.net - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.com with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.com with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list administrators).
RE: Computer simulation of the IEC1000-4-5 surge waveform
Hi, The 1.2/50 us impulse circuit is described in IEC 950, 4 th Amendment, Annex N. It has values for the components. If you don't have the standard, give me a call. Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 574 9752 e-mail: ndev...@entela.com -- From: plaw...@west.net[SMTP:plaw...@west.net] Reply To: plaw...@west.net Sent: Friday, September 04, 1998 12:29 PM To: emc-p...@majordomo.ieee.org Subject: Computer simulation of the IEC1000-4-5 surge waveform I'd like to do a simulation of the IEC1000-4-5 1.2/50us surge waveform. The test specification shows a simplified schematic in Figure 1, but no component values are given. Does anyone know what a good starting point would be for the component values? The spec also makes reference to this waveform being defined in IEC60-1 and IEC469-1 (neither of which I have), in case component values are in those documents. -- Patrick Lawler plaw...@west.net - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.com with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.com with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list administrators).
RE: Water Damage to Chambers
Hi, At my former employer, we had a fire in one of the chambers. We think that a section of cones came loose from the ceiling and came into contact with a flood light. The flood light was on an extension pole to get it past the cones. The cones just slid down the pole till it came into contact with the flood light. When the cones contacted the flood light they started to smolder. Since we did not have a smoke sensor on the ceiling vent, it smolder for a long time. We were running radiated immunity tests, so the door to the chamber was closed. Eventually, it got hot enough for the sprinklers in the chamber operated. When they turned on, the water spray forced the smoke out the bottom vent. That was the first we knew of the fire. Did you know that standard sprinkler heads are designed to spray out and down, but not up. Because the sprinkler heads were also on extensions to get them past the cones, they did not spray the cones above the heads. The fire department came and had to pull down the ceiling cones to put out the fire. So, to answer your questions. 1. From past experience, once the panels get soaked, they are trashed. The steel rusts and the wood swells. We had to completely replace the chamber. We did manage to salvage a few sections, but most of it was trashed. 2. The fire protection method used depends on what is burning. If it is the cone, I think only a lot of water would put it out. If it was the EUT, CO2 or halon would be the best. But, I think then you run into OSHA problems with these systems. Something about people in enclosed spaces in a toxic atmosphere :-) Lesson No. 1, don't use just adhesive to secure cones. Lesson No. 2, flood lights get very hot! Use incandescent bulbs. Lesson No. 3, put a smoke detector at the top vent for the chamber Lesson No. 4, use 360 Deg. sprinkler heads in the chamber. Lesson No. 5, Murphy was an optimist. Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 248 0591 e-mail: ndev...@entela.com -- From: WOODS, RICHARD[SMTP:wo...@sensormatic.com] Reply To: WOODS, RICHARD Sent: Tuesday, September 01, 1998 1:38 PM To: 'emc-pstc' Subject: Water Damage to Chambers As part of our hurricane preparedness, we have to consider what would happen to our EMC chambers if they get wet. 1) Can anyone provide some real life guidance on the ability of the laminated walls (steel and wood) to withstand a good soaking? 2) Also, what is the most advisable fire protection method for inside of chambers: water, CO2, other? Richard Woods Sensormatic Electronics wo...@sensormatic.com Views expressed by the author do not necessarily represent those of Sensormatic. - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.com with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.com with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, ri...@sdd.hp.com, or roger.volgst...@compaq.co (the list administrators).
RE: isopropyl alcohol
Hi, Typically we require a Certificate of Conformance traceable to NIST with the shipments. If a CoC is not available, then we run a chemical analysis. The chemical then goes into our calibration data base and is marked with an asset number and if necessary, shelf life. -- From: Jon D Curtis[SMTP:j...@world.std.com] Sent: Friday, July 10, 1998 10:37 AM To: Chris Dupres Cc: Ned Devine; emc-pstc Subject: Re: isopropyl alcohol What if anything are laboratories doing to calibrate chemical solutions? Seems to me that as an ISO Guide 25 laboratory, an analysis of the batch of the solution to nationally tracible standards by an ISO Guide 25 laboratory is required. What are other laboratories doing to calibrate chemical solutions? Jon D. Curtis, PE Curtis-Straus LLC j...@curtis-straus.com Laboratory for EMC, Safety, NEBS, SEMI-S2 and Telecom 527 Great Roadvoice (978) 486-8880 Littleton, MA 01460 fax (978) 486-8828 http://www.curtis-straus.com On Fri, 10 Jul 1998, Chris Dupres wrote: Hi Ned. You wrote: I need some help to solve a difference of opinion. A number of standards require isopropyl alcohol for durability of marking test. e.g. IEC 1010-1, Clause 5.3 and IEC 601-1, Clause 6.1.z. The difference in opinion is in the concentration. The standards just state isopropyl alcohol. Some say 70% others say 100%. What are other people using? I use a material labelled 'Isopropyl Alcohol' for the rub test. That's what it says on the tin, and I can only assume that it is 100%. I am sure that it is 100% because spills evaporate very quickly and leave no water behind, I'm sure that if it was diluted the water would remain long after the IPA had gone. Does that make sense?. Chris Dupres Surrey, UK.
UK E
Hi, I had someone ask me about the UK electricity at work act of 1989. He said it has something to do with leakage current. Has anyone heard of this? If so, what is it? Ned Devine Entela, Inc. Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 248 0591 e-mail: ndev...@entela.com
National Deviations for IEC 950
Hello, I am looking for the CB Scheme national deviations to IEC 950. I believe that they are specified in CB Bulletin 89A I. Can anybody verify this? Also, does anyone know if the CB Bulletin's are on the web? Thanks Ned Devine Entela, Inc. Program Manager III Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 248 0591 e-mail: ndev...@entela.com
RE: European Exercise Equipment
Mel, Make sure that the treadmill is not part of a medical Stress System. Typically, a Stress System uses a treadmill to stress the heart. Ned Devine Entela, Inc. Toll Free: 1 800 888 3787 Ext. 671 Direct: 1 616 248 9671 Fax:1 616 248 0591 e-mail: ndev...@entela.com -- From: Mel Pedersen[SMTP:mpeder...@sun1.anza.com] Reply To: Mel Pedersen Sent: Monday, March 23, 1998 12:03 PM To: 'emc-pstc' Subject: European Exercise Equipment Hello: We have received a request from a customer to approve a transformer going into a treadmill. What standard would apply here for the treadmill and the transformer? I thought possibly EN 60742, would that be valid here, or would the end product standard dictate the requirements for the transformer? Thank you all, Mel PedersenMidcom, Inc. Homologations Engineer Phone: (605) 882-8535 mpeder...@midcom.anza.com Fax: (605) 886-6752
Sound Pressure Meter
Hello, I am looking for an instrument to measure sound pressure per IEC 1010-1, Clause 12.5.1. In particular, I am looking for an instrument that ...conform either to type 1 of IEC 651 or, if an integrated sound level meter, to type 1 of IEC 804;. Currently I am using a Simpson, Model 884-2 sound level meter. But, the manufacture states that it does not meet the requirements of IEC 1010-1. Ned Devine Entela, Inc. Toll Free: 1 800 888 3787 Direct: 1 616 248 9671 Fax:1 616 248 0591 e-mail: ndev...@entela.com
Cadmium
Hello, I believe that the EU has restrictions on the use of cadmium (e.g. cadmium plated connectors). Does any one know where this is documented? Ned Devine Entela, Inc. Toll Free: 1 800 888 3787 Direct: 1 616 248 9671 Fax: 1 616 248 0591 e-mail: ndev...@entela.com
re: CE Procedures - Manufacturer traceabilit
Hi, I don't have any information on other directives, but the Medical Device Directive (93/43/EEC), Article 1, clause f, has a definition of the manufacture (see below). What it basically means is that if your name is on the device, you are considered the manufacture. As the manufacture you are responsible for the conformity of the device to all applicable directives (i.e. you issue the DoC). You of course can reference the OEM's technical file(s) in your technical file. We just require/suggust you to have contractual agreements for access to these files. In order to avoid confusion, we do not allow products to be marked device A, made by B, or device A made by B for C, or device A made for B, or device A distributed by B, or similar wording. Ned Devine TUV Product Service ndev...@tuvps.com (f) 'manufacturer' means the natural or legal person with responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party. The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, full refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient; - Original Text From: jeich...@statpower.com, on 04/18/1997 11:01 AM: To: emc-p...@majordomo.ieee.org I have been asked to look into the details of private-labelling a stand-alone OEM product on which the OEM places the CE Mark and for which the OEM has issued a Declaration of Conformity. If we have the OEM put our name on this product, but do not issue our own DofC, does the actual manufacturer's name have to appear somewhere on the product or packaging? In other words, does the EU want to be able to trace the actual manufacturer just from looking at the product itself at the user or retail level? Where is this addressed: in the Directives? I have checked 93/68/EEC, 89/336/EEC, and 73/23/EEC and find no requirement that a mfr's name accompany the CE mark on the product. Thanks in advance for your help, Jim Eichner Statpower Technologies Corporation jeich...@statpower.com Any opinions expressed are those of my invisible friend
re: Leakage Current
Ray, The clause you are trying to comply with is 4.4.2.2, single fault condition for protective conductor. Per 4.4.2.2 the exception are ...except for PERMANENTLY CONNECTED EQUIPMENT or equipment utilizing a connector in accordance with IEC 309. The most common solution I have seen it to replace your IEC 320 attachment plug with a IEC 309 attachment plug. Ned Devine TUV Product Service ndev...@tuvps.com 612 638 0246 - Original Text From: ray_russ...@leco.com, on 04/17/1997 9:05 AM: To: emc-p...@ieee.org Dear Friends, We have a large piece of lab equipment that uses 3 vacuum pumps and several power supplies. The controllers for the pumps are stand alone type, fully encased. We take these controllers and power supplies and install them inside our equipment. The problem that we have is that the controllers and some of the power supplies have their own EMI filtering. This causes the leakage current of each one to be between .5 mA and 1 mA, well within the limits. But when we install them inside of our end product, these add together with the EMI filters of the end product to create a high leakage current of 6 mA. (We are using EN 61010 clause 6.3.2.2, and these values are measured with the ground wire open.) I see 3 possibilities, but could use some feed back, as there is wisdom in many counselors. 1. The controller manufacturer has stated that we could isolate the ground path to the Y caps in their unit. The draw back here is the modification of an approved component. 2. Change from a detachable line cord to a permanent wiring scheme, and provide another ground wire. So in the event the ground wire in the line cord breaks, there is another ground path. Although I've seen this, I can not find any reference to this construction in EN 61010. 3. Provide multiple line cords. I'm not sure this will work because of the disconnect requirements. Thank you for your thoughts on this issue. Regards, Ray Russell ray_russ...@leco.com
re: Medical Devices Directive
Hello,
I don't know if it is on the WEB, but I have an electronic copy of the MDD.
It is about 180Kb. I have not check to see if it is 100% accurate. So
use at your own risk. Let me know if you would like a copy.
Ned Devine
TUV Product Service
ndev...@tuvps.com
-
Original Text
From: Massimo Polignano regr...@esaote.it, on 03/12/1997 4:05 PM:
To: emc-p...@ieee.org
Does anybody know if the Medical Devices Directive 93/42/EEC text is
available somewhere on the WEB: I'd like to pick it up and use it with
a word processor.
Thanks
M. P.
--
ESAOTE S.p.A. Ing. Massimo Polignano
Research Product Development Regulatory Affairs
Via di Caciolle, 15 Tel: ++ 39 (0)55 4229 402
50127 Firenze - Italy Fax: ++ 39 (0)55 4223305
e-mail regr...@esaote.it
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re: IEC 1010-1 - Fuses
Hello,
In general, we require that all non-operator replaceable fuse(s) be
specified in the service manual. e.g F1 - Type T, 3 A, 250 V.
Ned Devine
TUV Product Service
ndev...@tuvps.com
-
Original Text
From: Randy Stephens steph...@vivanet.com, on 03/11/1997 10:53 AM:
To: emc-p...@ieee.org
I have a question with regards to IEC 1010-1.
Section 5.1.4 states:
For any fuses which may be raplaced by an operator there shall be a
marking beside the fuseholder specifying the current rating and type ...
by the codes of IEC 127. For fuses not replaceable by the operator the
same information shall be provided in the documentaion.
So, what happens if the fuses which are not replaceable by the operator
are not on the AC Mains, but on a secondary circuit? What if these fuses
are not IEC 127 type fuses (i.e. micro-fuses, fusible resistors,
resistive links, thermal fuses, etc.)? Do we just state exactly what
fuse IS currently used in the manual along with a statement that this
particular fuse is NOT operator replacable?
I am just looking for information where the fuses are on the secondary
of an isolation transformer.
Any help would be appreciated.
Randy Stephens
Trek, Inc.
Medina, N.Y.
begin 666 ATTRIBS.BND
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re: GS Mark
Hi, Per the Low Voltage Directive, Article 10, TUV Product Service's number is 5. Ned Devine TUV PS ndev...@tuvps.com - Original Text From: George Alspaugh geor...@lexmark.com, on 02/25/1997 9:31 AM: To: emc-pstc%ieee.org emc-p...@ieee.org We have used TUV Rheinland for authorization to use German GS mark, with numeral 2 signifying TUV Rheinland as the approving agency. Does anyone know the numeral designation for TUV Product Service when used as the approving agency?George AlspaughLexmark International
