Re: Production Line Test Requirements - Medical Devices
Hi John: Because continuity at low current does not ensure that the protective circuit will carry a large fault current - it might be 'hanging on by one strand'. Yes, for one strand. No, for five strands. Some years ago, I did some experiments on what problems the 25-amp test would detect. I simulated broken strands by cutting them one at a time. With five strands intact, the circuit passed the 25-amp, 2-minute test. It failed at 4 strands and 1 minute. (The tested wire was 18 AWG comprised of 36 strands of 34 AWG.) The ability of a few strands to carry the 25-amp current depends on the free length of the those few strands, which in turn determines the heat-sinking provided to those strands. The free length was on the order of 3 mm. My experiment assumed the problem was caused by an incorrectly set wire stripper, that cut a number of strands. So there was a very small free length of strands. I published this study in the Product Safety Newsletter, Vol. 10, No.1, January-March, 1997. Best regards, Rich --- 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,
Environmental test labs
Greetings all, I am looking for recommendations for a NEBS environmental test lab that has an operational temp/humidity chamber of significant size and with tremendous cooling capacity (8kW or more). I have a large (6+'wide, 7+'tall) telecom product that consumes about 8kW of energy during operation and I am having trouble finding environmental labs with chambers that can handle this without a liquid nitrogen feed. I am based in the Boston area and am talking to a few local labs, but my next product will be bigger and use more power. I am willing to expand the search outside of the Boston area since no one I know will likely be able to handle it. All you lab sales guys out there - I am actually asking for you to contact me on this one (OFF LIST, private email, of course). Thanks in advance, Dave Heald --- 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: Cooking induction apparatus and FCC
Sorry, once again ham fisted typing lead to C64.5 rather than the proper C63.4 - my error hope it didn't confuse to many folks. Thanks for straightening that out. Gary -Original Message- From: rehel...@mmm.com [mailto:rehel...@mmm.com] Sent: Monday, May 21, 2001 12:39 PM To: Gary McInturff Cc: emc-p...@majordomo.ieee.org Subject: RE: Cooking induction apparatus and FCC Part 18 still uses MP-5 but it is not mandatory. In cases of dispute, MP-5 will be used by the FCC. You can't go wrong, however, using ANSI C63.4 as the test set-up. Or you can use the CISPR limits as Gary described. I do not know what C64.5 is. You do not have to submit your test results through a TCB. Bob Heller 3M Product Safety, 76-1-01 St. Paul, MN 55107-1208 Tel: 651- 778-6336 Fax: 651-778-6252 Gary McInturff Gary.McInturff@worldwidepa To: 'Pierre SELVA' pierre.se...@worldonline.fr ckets.com Forum Safety-emc emc-p...@majordomo.ieee.org cc: (bcc: Robert E. Heller/US-Corporate/3M/US) 05/21/2001 10:59 AM Subject: RE: Cooking induction apparatus and FCC Please respond to Gary McInturff Bon Jour (That's about it for my French) Pierre, MP-5 isn't relevant any more. I believe you want ANSI C64.5. and I think you'll find mostly similarities. I can't think of any dissimilarities of the top of my head, Even FCC part 15 allows use of the CISPR limits for radiated and conducted emissions. The only caveat (ah, more French!) is that if you accept the radiated limits during test you also have to accept the conducted limits. Some folks trip up on that one. It means that the conducted limits are really 150Khz even at US line voltage, not the normal FCC start of 450 Khz. Gary -Original -Original Message- From: Pierre SELVA [mailto:pierre.se...@worldonline.fr] Sent: Monday, May 21, 2001 6:09 AM To: Forum Safety-emc Cc: Pierre SELVA Subject: Cooking induction apparatus and FCC Dear colleagues, I need to know your opinion on the following : I have to perform EMC testing on an induction cooking table and I would like to obtain the FCC certification. In Europe, this kind of apparatus is subjected to the EN55011 (CISPR11) and the test conditions are clearly stated, mainly for the EUT configuration. I understand for the USA, the product has to be tested according to Part 18 requirements. This part explains that the technical requirements for the measurement are described in the MP-5 document. As this one is a little bit old (1986), do you believe I can use the CISPR11 to demonstrate compliance, or should I use the MP5 ? If I have to use the MP-5, do you know if somewhere the EUT configuration is described, or is the worst case at the manufacturer discretion ? And, at last, do you know if I have to submit my test results and EUT description to FCC directly (electronic submittal), or should I have to go to a TCB ? In advance, I thank you a lot for your answers, Best regards from France Pierre SELVA 2 route de la Grobelle 73000 JACOB BELLECOMBETTE - France Tel : 33 (0)6 60 52 04 96 Fax : 33 (0)6 61 37 87 48 e-mail : mailto:pierre.se...@worldonline.fr pierre.se...@worldonline.fr mailto:pierrese...@onetelnet.fr pierrese...@onetelnet.fr File att1.htm not included with reply --- 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: Cooking induction apparatus and FCC
Part 18 still uses MP-5 but it is not mandatory. In cases of dispute, MP-5 will be used by the FCC. You can't go wrong, however, using ANSI C63.4 as the test set-up. Or you can use the CISPR limits as Gary described. I do not know what C64.5 is. You do not have to submit your test results through a TCB. Bob Heller 3M Product Safety, 76-1-01 St. Paul, MN 55107-1208 Tel: 651- 778-6336 Fax: 651-778-6252 Gary McInturff Gary.McInturff@worldwidepa To: 'Pierre SELVA' pierre.se...@worldonline.fr ckets.com Forum Safety-emc emc-p...@majordomo.ieee.org cc: (bcc: Robert E. Heller/US-Corporate/3M/US) 05/21/2001 10:59 AM Subject: RE: Cooking induction apparatus and FCC Please respond to Gary McInturff Bon Jour (That's about it for my French) Pierre, MP-5 isn't relevant any more. I believe you want ANSI C64.5. and I think you'll find mostly similarities. I can't think of any dissimilarities of the top of my head, Even FCC part 15 allows use of the CISPR limits for radiated and conducted emissions. The only caveat (ah, more French!) is that if you accept the radiated limits during test you also have to accept the conducted limits. Some folks trip up on that one. It means that the conducted limits are really 150Khz even at US line voltage, not the normal FCC start of 450 Khz. Gary -Original -Original Message- From: Pierre SELVA [mailto:pierre.se...@worldonline.fr] Sent: Monday, May 21, 2001 6:09 AM To: Forum Safety-emc Cc: Pierre SELVA Subject: Cooking induction apparatus and FCC Dear colleagues, I need to know your opinion on the following : I have to perform EMC testing on an induction cooking table and I would like to obtain the FCC certification. In Europe, this kind of apparatus is subjected to the EN55011 (CISPR11) and the test conditions are clearly stated, mainly for the EUT configuration. I understand for the USA, the product has to be tested according to Part 18 requirements. This part explains that the technical requirements for the measurement are described in the MP-5 document. As this one is a little bit old (1986), do you believe I can use the CISPR11 to demonstrate compliance, or should I use the MP5 ? If I have to use the MP-5, do you know if somewhere the EUT configuration is described, or is the worst case at the manufacturer discretion ? And, at last, do you know if I have to submit my test results and EUT description to FCC directly (electronic submittal), or should I have to go to a TCB ? In advance, I thank you a lot for your answers, Best regards from France Pierre SELVA 2 route de la Grobelle 73000 JACOB BELLECOMBETTE - France Tel : 33 (0)6 60 52 04 96 Fax : 33 (0)6 61 37 87 48 e-mail : mailto:pierre.se...@worldonline.fr pierre.se...@worldonline.fr mailto:pierrese...@onetelnet.fr pierrese...@onetelnet.fr File att1.htm not included with reply --- 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: Public Health and Safety Signs - Tomfoolery so delete if you
200105211432.kaa24...@interlock2.lexmark.com, oover...@lexmark.com inimitably wrote: I once read a safety article (tongue-in-cheek I believe) that said that the safety industry was weaking the species by allowing the weak and feable to continue exist and procreate. I believe that this was directed toward the mentally weak and feable (read stoopid). By warning them about things that generally intellegient people would know were hazardous, this special group would reproduce and create even more special people. Ultimately, the special people would out number the others to such an extent that homosapiens would face extinction. One of the assumptions was that these special people, through their routine actions, would eliminate most of the other people through collateral damage. (e.g. drunk drivers, cell phone drivers, equipment operators, greedy managers with only the bottom line in mind (otherwise known as bottom feeders)) Well, it has gotten to the point, as Tania has so elegantly pointed out, that the safety profession only facilitates this; but the legal and political system now rewards being special (again read stoopid). Not only do we protect them and allow them to procreate, we pay them large sums of money to those special people for being so special. This is a distasteful posting, and even if you wrote it in innocence you may find you get attention from extreme right-wing elements. The idea that low intelligence is a dominant inherited characteristic is simply not true. There is a heuristic observation of an 'equalization' principle in human and other animal inheritance; unusually tall parents have tall but not so unusually tall children. Many highly intelligent parents have children whose intelligence is not so outstanding. Some simple parents have genius-level children. -- Regards, John Woodgate, OOO - Own Opinions Only. Phone +44 (0)1268 747839 Fax +44 (0)1268 777124. http://www.jmwa.demon.co.uk Why not call a vertically- applied manulo-pedally-operated quasi-planar chernozem-penetrating and excavating implement a SPADE? --- 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
36BDBCA75E0FD411A80100104B93ABF202C2C079@MGCMAIL, Dick Grobner dick.grob...@medgraph.com inimitably wrote: Why wouldn't a simple continuity tests as defined by UL be appropriate from equipment coming off of the production line (assuring that the protective earth circuit in intake)? Because continuity at low current does not ensure that the protective circuit will carry a large fault current - it might be 'hanging on by one strand'. -- Regards, John Woodgate, OOO - Own Opinions Only. Phone +44 (0)1268 747839 Fax +44 (0)1268 777124. http://www.jmwa.demon.co.uk Why not call a vertically- applied manulo-pedally-operated quasi-planar chernozem-penetrating and excavating implement a SPADE? --- 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: UL P.A.G.
lobbjbnlajjdfilpcaancehncjaa.peperkin...@cs.com, Pete Perkins peperkin...@cs.com inimitably wrote: Some standards committees themselves work to clarify the requirements; for instance TC74/IEC 60950 has a chairman's advisory panel that will answer questions from IEC national committees (not from individuals) that are phrased in a manner that they can be answered by a simple yes/no response. On occasion the process of answering these questions has prompted a change in the standard to provide additional clarification to the issue. These answers are provided back to the IEC national committees for distribution. IEC TC92 (responsible for IEC/EN60065) has a similar arrangement, but will respond to questions requiring a quite complex response. Within the CB Scheme the CTL (Committee of Testing Laboratories) has an internal method for polling laboratories as to interpretation of requirements or testing practice and, after discussion, providing an agreed-upon interpretation for all labs to use. This is intended to provide uniform interpretation and application of requirements and testing throughout all of the participating labs on a worldwide basis. I dont believe that these interpretations are generally available outside the labs. TC92 now sends its interpretations to CTL and to CENELEC OSM (a similar body), also to all IEC National Committees, who are expected to make the interpretations publicly available (but not necessarily free, AIUI). -- Regards, John Woodgate, OOO - Own Opinions Only. Phone +44 (0)1268 747839 Fax +44 (0)1268 777124. http://www.jmwa.demon.co.uk Why not call a vertically- applied manulo-pedally-operated quasi-planar chernozem-penetrating and excavating implement a SPADE? --- 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,
Test Equipment
Hello group, I am interested in purchasing some new/used test equipment. I am looking specifically for a 'Digital Balance Analyzer' and an 'AC Stress/Hazardous Voltage/Hazardous Current Analyzer'. Any suggestions would be appreciated. Thanks, Courtland Thomas Patton Electronics --- 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: UL P.A.G.
Hi You mentioned the CTL Decisions. While I understand that not all the decisions have been placed on the web yet, you will find many of them at www.iecee.org. Try under CTL or CTL Decisions John Fee National Electronics Technology Centre Enterprise Ireland Phone +353-1-8082214 Fax +353-1-8370705 email f...@netc.ie -Original Message- From: Pete Perkins [mailto:peperkin...@cs.com] Sent: 21 May 2001 16:12 To: PSNet; Brian O'Connell Subject: RE: UL P.A.G. PSNet UL Practical application guide discussion Several good points have been made in the discussion of the practical application guide supplied by UL; Ill add my U$ two-bits worth here Let's start with a story: the question of interpretation has been with us for a long time. An old timer, a German trained engineer who later worked for a test house, described his indoctrination into the world of safety testing. As a beginning engineer, one day his boss came to him and said when they go up to VDE to have the product examined he should remember to take along his copy of the standard and make notes in the margin as to the interpretation of requirements as they were described. Later, as a project engineer, when he took his product to VDE his boss reminded him to take along the new engineer with his copy of the standard to do the same thing. This was obviously training by apprenticeship. Having worked in standards development arena for 25 years or so, I found that is not easy to make the standard absolutely clear there is an ongoing pressure for conciseness and compromise (since it is written by a committee - you know all the old jokes: an elephant is a mouse designed to MIL specs; a camel is a donkey designed by a committee). This means that there also is ongoing effort to get clarification of requirements and to clarify the written standard itself. We know that in large companies there is considerable discussion among designers and safety engineering professionals as to the intent and requirements of the standards. In some cases it is organized, but much is not. Much of the discussion that we have here on the PSNet is along the same lines - to provide the experience of others to help clarify the requirements or the intent of the requirements in a standard. As with the company efforts, the advent of email has gone a long way to get things written down, but not always organized in any recoverable way (RCIC not withstanding). My experience is that UL engineers are generally not familiar with the PSNet discussions. There are some formal, traditional efforts to do this clarification codification. Some standards committees themselves work to clarify the requirements; for instance TC74/IEC 60950 has a chairman's advisory panel that will answer questions from IEC national committees (not from individuals) that are phrased in a manner that they can be answered by a simple yes/no response. On occasion the process of answering these questions has prompted a change in the standard to provide additional clarification to the issue. These answers are provided back to the IEC national committees for distribution. Within the CB Scheme the CTL (Committee of Testing Laboratories) has an internal method for polling laboratories as to interpretation of requirements or testing practice and, after discussion, providing an agreed-upon interpretation for all labs to use. This is intended to provide uniform interpretation and application of requirements and testing throughout all of the participating labs on a worldwide basis. I dont believe that these interpretations are generally available outside the labs. Finally, UL has its P. A. G. that we've been discussing. This guide was developed so that UL engineers would provide the same interpretation of requirements from any office. It's really quite convenient that they offer this outside of the lab for use but there's no obligation to do so. Charging a nominal amount to support making this available does not, in my opinion, seem unreasonable. This could also easily be done on-line where you would be charged on a page-by-page basis (how many peeks per U$ dollar at those Russian sneak-a-peek sites - once you enter your credit card number?). Whether or not these are more than guidelines - it seems that trying to work around them is like trying to push aside the preponderance of the evidence in legal proceedings. In each case they are considered opinions from a group of knowledgeable participants in each process. It would be most convenient to find some way to combine all the interpretive information into the standard such as is done with the US NEC (National Electric Code) Handbook. In that book each clause is followed by interpretive information to further explain the application of the requirements. (Hmmm on reflection this looks like it would be a good retirement project for me if I could get my hands on the interpretations. What would you be willing to pay?) I hope that this little
RE: Cooking induction apparatus and FCC
Bon Jour (That's about it for my French) Pierre, MP-5 isn't relevant any more. I believe you want ANSI C64.5. and I think you'll find mostly similarities. I can't think of any dissimilarities of the top of my head, Even FCC part 15 allows use of the CISPR limits for radiated and conducted emissions. The only caveat (ah, more French!) is that if you accept the radiated limits during test you also have to accept the conducted limits. Some folks trip up on that one. It means that the conducted limits are really 150Khz even at US line voltage, not the normal FCC start of 450 Khz. Gary -Original -Original Message- From: Pierre SELVA [mailto:pierre.se...@worldonline.fr] Sent: Monday, May 21, 2001 6:09 AM To: Forum Safety-emc Cc: Pierre SELVA Subject: Cooking induction apparatus and FCC Dear colleagues, I need to know your opinion on the following : I have to perform EMC testing on an induction cooking table and I would like to obtain the FCC certification. In Europe, this kind of apparatus is subjected to the EN55011 (CISPR11) and the test conditions are clearly stated, mainly for the EUT configuration. I understand for the USA, the product has to be tested according to Part 18 requirements. This part explains that the technical requirements for the measurement are described in the MP-5 document. As this one is a little bit old (1986), do you believe I can use the CISPR11 to demonstrate compliance, or should I use the MP5 ? If I have to use the MP-5, do you know if somewhere the EUT configuration is described, or is the worst case at the manufacturer discretion ? And, at last, do you know if I have to submit my test results and EUT description to FCC directly (electronic submittal), or should I have to go to a TCB ? In advance, I thank you a lot for your answers, Best regards from France Pierre SELVA 2 route de la Grobelle 73000 JACOB BELLECOMBETTE - France Tel : 33 (0)6 60 52 04 96 Fax : 33 (0)6 61 37 87 48 e-mail : mailto:pierre.se...@worldonline.fr pierre.se...@worldonline.fr mailto:pierrese...@onetelnet.fr pierrese...@onetelnet.fr
RE: Cooking induction apparatus and FCC
-Original Message- From: Pierre SELVA [mailto:pierre.se...@worldonline.fr] Sent: Monday, May 21, 2001 6:09 AM To: Forum Safety-emc Cc: Pierre SELVA Subject: Cooking induction apparatus and FCC Dear colleagues, I need to know your opinion on the following : I have to perform EMC testing on an induction cooking table and I would like to obtain the FCC certification. In Europe, this kind of apparatus is subjected to the EN55011 (CISPR11) and the test conditions are clearly stated, mainly for the EUT configuration. I understand for the USA, the product has to be tested according to Part 18 requirements. This part explains that the technical requirements for the measurement are described in the MP-5 document. As this one is a little bit old (1986), do you believe I can use the CISPR11 to demonstrate compliance, or should I use the MP5 ? If I have to use the MP-5, do you know if somewhere the EUT configuration is described, or is the worst case at the manufacturer discretion ? And, at last, do you know if I have to submit my test results and EUT description to FCC directly (electronic submittal), or should I have to go to a TCB ? In advance, I thank you a lot for your answers, Best regards from France Pierre SELVA 2 route de la Grobelle 73000 JACOB BELLECOMBETTE - France Tel : 33 (0)6 60 52 04 96 Fax : 33 (0)6 61 37 87 48 e-mail : mailto:pierre.se...@worldonline.fr pierre.se...@worldonline.fr mailto:pierrese...@onetelnet.fr pierrese...@onetelnet.fr
RE: Production Line Test Requirements - Medical Devices
Jon Thx for the info, however, I re-checked the two known US standards (UL2601, Appendix D - Manufacturer's Responsibilities, Construction Considerations and Requirements for Factory Tests) (NFPA 99, Grounding Circuit Continuity - Measurement of Resistance). UL defines Production Line Grounding Continuity Test Equipment as: Any suitable continuity indication device (such as an ohmmeter, a battery and buzzer combination, or the like) may be used to determine compliance with Grounding Continuity Test requirements. The NFPA std is even less definitive on this matter. EN60601-1, Appendix B - Testing During Manufacture and/or Installation, Not Used. See rational to sub-clause 4.1. Which states - Tests described in this standard are type tests. I checked all of the amendments including EN60601-1 for medical systems, and I do not see anything changing this. My questions remains, where does it state to use the 10-25Amp, 50 or 60Hz @ 6Volt for 5 seconds test? Is this a carry over from another EN standard? Why wouldn't a simple continuity tests as defined by UL be appropriate from equipment coming off of the production line (assuring that the protective earth circuit in intake)? Appreciate your feedback Jon! thanks again. Does anyone else on this forum have any input - would appreciate it. -Original Message- From: Jon Griver [mailto:jo...@medson.com] Sent: Monday, May 21, 2001 9:16 AM To: Dick Grobner Subject: RE: Production Line Test Requirements - Medical Devices Dick, The requirements for production tests of medical equipment generally are: 1. Hipot at 1500AC - between live and neutral connected together and earth. 2. Earth continuity at 25A between earth pin on plug and enclosure (choose a point that may be problematic if there are manufacturing problems) 3. Earth and/or patient leakage. Whether you do both, one or neither of these tests depends on the product. As the production tests are intended to find production problems (as opposed to type tests which are intended to find design problems), choose the tests that you think make sense from the production engineering point of view. Document the reasoning behind your choice. IT equipment only requires Hipot and earth continuity tests. Hope this helps, Jon -Original Message- From: Dick Grobner [mailto:dick.grob...@medgraph.com] Sent: Monday, May 21, 2001 16:36 To: 'Jon Griver' Subject: RE: Production Line Test Requirements - Medical Devices Jon Thanks, you have confirmed what I thought I knew. We just had our annual ISO 9001 audit (2 weeks ago). One issue that one of the two auditors raised was why are you not doing the ground integrity test (25 Amp test) on 100% of your production units? I asked do you mean ground continuity (Ohm test) and he said no, the ground integrity test. That's when I started digging into the standards. UL (and the former ETL) states high potential and ground continuity tests on all production units. EN60601-1 states that all tests within this document are type tests. The auditor gave me no reference to any EN, etc. when I asked. So, I have a suspicion that this is his wish and not stated in any EN (at least that I know of so far). SO - I will continue to pursue with other outside sources (but not this one auditor!) Thanks for the reply back! PS - does ITE equipment require this test (ground integrity ((25 Amp)) test? -Original Message- From: Jon Griver [mailto:jo...@medson.com] Sent: Sunday, May 20, 2001 1:34 AM To: emc-p...@majordomo.ieee.org Subject: FW: Production Line Test Requirements - Medical Devices Dick, To the best of my knowledge there is no EN standard or guidance on production tests for medical equipment (There is a standard, EN 50116, for IT equipment). Your best bet is to discuss this with your Notified Body and to come to a mutually acceptable set of tests. Regards, Jon Griver Medson Ltd. Good Day Everyone Question I have - Does anyone out there know if an EN standard or guidance document exists that deals with production line test requirements of finished medical devices. Reading in EN60601-1 it states that the test (ground resistance, high potential, etc.) are type test only (See appendix B, and then paragraph 4.1). Thus - they are not identified as production line tests. I know that the NRTL's in the USA (UL/ETL) specifically call out what tests are to be performed after the production build of equipment. Any input would be appreciated. Thx 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
RE: Public Health and Safety Signs - Tomfoolery so delete if you don't have the time.
Gary, We learned about this one almost 13 years ago with the first baby... My wife inadvertently went through about a pot of coffee while on the phone (long distance) with a rarely seen friend. In a way, the results of that were much worse than passing on a glass of wine or two!! Since neither one was used to that much coffee, in that short a period, it was unpleasant, but educational. From an engineering perspective: it was a very conclusive test! Daren A. Nerad EMC Engineer 815.226.6123 -Original Message- From: Gary McInturff [mailto:gary.mcintu...@worldwidepackets.com] Sent: Friday, May 18, 2001 4:40 PM To: 'Michael Mertinooke'; wo...@sensormatic.com; emc-p...@majordomo.ieee.org Subject: RE: Public Health and Safety Signs - Tomfoolery so delete if you don't have the time. Here in the US, awhile back, a woman was suing the liquor industry because she gave birth to a fetal alcohol syndrome child. Apparently, nobody in their right mind would assume that consuming a fifth of whiskey a day could be harmful to a developing fetus making the liquor industry patiently and damnably negligent in not putting warning labels on the bottles. (We got them now thank God!) During the coverage of the trial, and I don't remember the context, but the issue of passing nastiness to infants who were being breast fed was also brought up. While I didn't hear the end of this I often have wondered that if that was true, and this woman's case had merit (her lawyer took it up didn't he?) then the logical extension would be that mothers milk should come with a warning. Soo Just what the heck will this label look like, and even more importantly, just where are they going to put it so that people, can easily read it! Gary -Original Message- From: Michael Mertinooke [mailto:mertino...@skyskan.com] Sent: Friday, May 18, 2001 12:37 PM To: wo...@sensormatic.com; emc-p...@majordomo.ieee.org Subject: RE: Public Health and Safety Signs signs at work. Is there a similar Directive for health and safety signs for the general public? Whoo! The mind boggles! You mean with like people with exclamation point in triangle tattoos on various portions of the anatomy? Or biohazard labels on the door of the kids' rooms? Judging from some of the ANSI Z535 safety labels I see in the catalogs, the Human Warning Labels would be interesting indeed. =] Cheers! Mike --- 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, --- 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: UL P.A.G.
PSNet UL Practical application guide discussion Several good points have been made in the discussion of the practical application guide supplied by UL; I’ll add my U$ two-bits worth here Let's start with a story: the question of interpretation has been with us for a long time. An old timer, a German trained engineer who later worked for a test house, described his indoctrination into the world of safety testing. As a beginning engineer, one day his boss came to him and said when they go up to VDE to have the product examined he should remember to take along his copy of the standard and make notes in the margin as to the interpretation of requirements as they were described. Later, as a project engineer, when he took his product to VDE his boss reminded him to take along the new engineer with his copy of the standard to do the same thing. This was obviously training by apprenticeship. Having worked in standards development arena for 25 years or so, I found that is not easy to make the standard absolutely clear – there is an ongoing pressure for conciseness and compromise (since it is written by a committee - you know all the old jokes: an elephant is a mouse designed to MIL specs; a camel is a donkey designed by a committee). This means that there also is ongoing effort to get clarification of requirements and to clarify the written standard itself. We know that in large companies there is considerable discussion among designers and safety engineering professionals as to the intent and requirements of the standards. In some cases it is organized, but much is not. Much of the discussion that we have here on the PSNet is along the same lines - to provide the experience of others to help clarify the requirements or the intent of the requirements in a standard. As with the company efforts, the advent of email has gone a long way to get things written down, but not always organized in any recoverable way (RCIC not withstanding). My experience is that UL engineers are generally not familiar with the PSNet discussions. There are some formal, traditional efforts to do this clarification codification. Some standards committees themselves work to clarify the requirements; for instance TC74/IEC 60950 has a chairman's advisory panel that will answer questions from IEC national committees (not from individuals) that are phrased in a manner that they can be answered by a simple yes/no response. On occasion the process of answering these questions has prompted a change in the standard to provide additional clarification to the issue. These answers are provided back to the IEC national committees for distribution. Within the CB Scheme the CTL (Committee of Testing Laboratories) has an internal method for polling laboratories as to interpretation of requirements or testing practice and, after discussion, providing an agreed-upon interpretation for all labs to use. This is intended to provide uniform interpretation and application of requirements and testing throughout all of the participating labs on a worldwide basis. I don’t believe that these interpretations are generally available outside the labs. Finally, UL has its P. A. G. that we've been discussing. This guide was developed so that UL engineers would provide the same interpretation of requirements from any office. It's really quite convenient that they offer this outside of the lab for use but there's no obligation to do so. Charging a nominal amount to support making this available does not, in my opinion, seem unreasonable. This could also easily be done on-line where you would be charged on a page-by-page basis (how many peeks per U$ dollar at those Russian sneak-a-peek sites - once you enter your credit card number?). Whether or not these are more than guidelines - it seems that trying to work around them is like trying to push aside the preponderance of the evidence in legal proceedings. In each case they are considered opinions from a group of knowledgeable participants in each process. It would be most convenient to find some way to combine all the interpretive information into the standard such as is done with the US NEC (National Electric Code) Handbook. In that book each clause is followed by interpretive information to further explain the application of the requirements. (Hmmm – on reflection this looks like it would be a good retirement project for me if I could get my hands on the interpretations. What would you be willing to pay?) I hope that this little summary is useful. br, Pete Peter E Perkins, PE Principal Product Safety Consultant Tigard, ORe 97281-3427 503/452-1201 fone/fax p.perk...@ieee.org --- 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:
RE: Li-ion Batteries
Is there a European standard for Li-ion batteries? Is there a battery directive? If yes, what standards is applicable? CE mark required? -- As far as I know, the relevant EU directive is 98/101/EC, 22 December 1998, which adapts 91/157/EEC on batteries and accumulators. This only relates to the chemicals used in the battery. I asked Moltech Power Systems (Energizer) what directives applied to EU, and got the reply attached below. Mike Mertinooke -- Michael: Are you joking with this response? Are you kidding me? Regards, Joe DeCarlo Moltech Power Systems Ph: 860-257-1020 Fx: 860-257-0165 --- 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: Public Health and Safety Signs - Tomfoolery so delete if you
I once read a safety article (tongue-in-cheek I believe) that said that the safety industry was weaking the species by allowing the weak and feable to continue exist and procreate. I believe that this was directed toward the mentally weak and feable (read stoopid). By warning them about things that generally intellegient people would know were hazardous, this special group would reproduce and create even more special people. Ultimately, the special people would out number the others to such an extent that homosapiens would face extinction. One of the assumptions was that these special people, through their routine actions, would eliminate most of the other people through collateral damage. (e.g. drunk drivers, cell phone drivers, equipment operators, greedy managers with only the bottom line in mind (otherwise known as bottom feeders)) Well, it has gotten to the point, as Tania has so elegantly pointed out, that the safety profession only facilitates this; but the legal and political system now rewards being special (again read stoopid). Not only do we protect them and allow them to procreate, we pay them large sums of money to those special people for being so special. Tania Grant taniagrant%msn@interlock.lexmark.com on 05/18/2001 09:11:49 PM Please respond to Tania Grant taniagrant%msn@interlock.lexmark.com To: Gary McInturff gary.mcinturff%worldwidepackets@interlock.lexmark.com, 'Michael Mertinooke' mertinooke%skyskan@interlock.lexmark.com, woods%sensormatic@interlock.lexmark.com, emc-pstc%majordomo.ieee@interlock.lexmark.com cc:(bcc: Oscar Overton/Lex/Lexmark) Subject: Re: Public Health and Safety Signs - Tomfoolery so delete if you Gary, Kudos to you for trying;-- but I think you are confusing your metaphors. And you can't equate logic with brainless juries or judges. And you know better than to rely on warning labels for safety protection! 1. It is assumed that intelligent people will make intelligent choices when opening a bottle with Warning labels that state the content can do you in. 2. It is assumed that a nursing baby, while potentially intelligent, does not have the capability to make any choices whatsoever as to what she is consuming. 3. It is assumed that a lactating mother has a direct effect on the well being of her baby. 4. Therefore, the mother is the responsible party for any adverse effects the baby may suffer due to conditions such as described in 1. above. 5. Therefore, we can assume that any decision rendered otherwise by judge and/or jury is brainless. For technological widgets we bend over backwards to make them safe and we don't rely on labels to protect the general user (trained service persons, however, can be protected by labels in certain cases). However, our legislators/politicians think they can affect and protect our behavior by labels and warning statements.This does not really work;--warning labels are for others, never for ourselves! So, what is the answer? -- Education for intelligent people; and safe design (in case of a single fault, and a subsequent fault) for dumb widgets. Plastering warning labels on breasts will no more eliminate alcoholic babies than plastering warning labels on men's ... will eliminate HIV. Tania Grant taniagr...@msn.com - Original Message - From: Gary McInturff Sent: Friday, May 18, 2001 5:33 PM To: 'Michael Mertinooke'; wo...@sensormatic.com; emc-p...@majordomo.ieee.org Subject: RE: Public Health and Safety Signs - Tomfoolery so delete if you Here in the US, awhile back, a woman was suing the liquor industry because she gave birth to a fetal alcohol syndrome child. Apparently, nobody in their right mind would assume that consuming a fifth of whiskey a day could be harmful to a developing fetus making the liquor industry patiently and damnably negligent in not putting warning labels on the bottles. (We got them now thank God!) During the coverage of the trial, and I don't remember the context, but the issue of passing nastiness to infants who were being breast fed was also brought up. While I didn't hear the end of this I often have wondered that if that was true, and this woman's case had merit (her lawyer took it up didn't he?) then the logical extension would be that mothers milk should come with a warning. Soo Just what the heck will this label look like, and even more importantly, just where are they going to put it so that people, can easily read it! Gary -Original Message- From: Michael Mertinooke [mailto:mertino...@skyskan.com] Sent: Friday, May 18, 2001 12:37 PM To: wo...@sensormatic.com; emc-p...@majordomo.ieee.org Subject: RE: Public Health and Safety Signs signs at work. Is there a similar Directive for health and safety signs for the general public? Whoo! The mind boggles! You mean with like people with exclamation point in triangle tattoos on various portions of the anatomy? Or
Cooking induction apparatus and FCC
Dear colleagues, I need to know your opinion on the following : I have to perform EMC testing on an induction cooking table and I would like to obtain the FCC certification. In Europe, this kind of apparatus is subjected to the EN55011 (CISPR11) and the test conditions are clearly stated, mainly for the EUT configuration. I understand for the USA, the product has to be tested according to Part 18 requirements. This part explains that the technical requirements for the measurement are described in the MP-5 document. As this one is a little bit old (1986), do you believe I can use the CISPR11 to demonstrate compliance, or should I use the MP5 ? If I have to use the MP-5, do you know if somewhere the EUT configuration is described, or is the worst case at the manufacturer discretion ? And, at last, do you know if I have to submit my test results and EUT description to FCC directly (electronic submittal), or should I have to go to a TCB ? In advance, I thank you a lot for your answers, Best regards from France Pierre SELVA 2 route de la Grobelle 73000 JACOB BELLECOMBETTE - France Tel : 33 (0)6 60 52 04 96 Fax : 33 (0)6 61 37 87 48 e-mail : pierre.se...@worldonline.fr pierrese...@onetelnet.fr
