EMC/EMI/ESD Requirements for Medical Electronics in US?
EMC-PSTC'ers, Does the United States have any electromagnetic compatibility (EMC), electromagnetic interference (EMI), or electrostatic discharge (ESD) standards for medical electronics? If so, where can I find them? A prospective client has asked about EMC/EMI/ESD testing for a wearable medical-monitor. It looks like the applicable standards for Europe are: * EN 55011:1998 +Amendment A1:1999. * EN 60601-1-2:2001. I found some references on the Internet to: * The Food and Drug Administration using UL 2601-1 for medical devices. * UL 2601-1 having the same immunity requirements as EN 60601-1-2. Having been bitten by supposedly-identical standards being just a little different in areas critical to products I've designed, we bought UL2601-1 ($155 with shipping and handling), and received it yesterday. The cover letter is dated June 16,2000, and describes it as Second Edition, Dated October 24, 1997. Section 39.2 has a couple of paragraphs about Prevention of electrostatic charges. Appendix A1, section A1.5.2, says The sensitivity of EQUIPMENT to external interference (electromagnetic field, perturbations of the supply voltage) is under consideration. Appendix L refers to IEC 601-1-2:1993. Is there a newer amendment to UL 2601-1 that has EMC/EMI/ESD requirements, or just what *do* people use to verify/certify medical electronics? Thanks! John Barnes dBi Corporation http://www.dbicorporation.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
48 Volt Telco Power Supply
Hello Group, Does anyone in the group know of a good supplier of 48 VDC Telco power supplies? My requirements: Input 120/240 VAC (universal or switchable) Output 48 VDC Power 750 watts Mounting19 inch rack Thanks in advance, Jim Robson Compliance Eng. Zetron Inc. --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@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
Banned Substances in Sweden
We have had a request from a customer to verify a lack of certain substances in one of our products. Rather than provide us with a regulatory-based list of substances, they have provided us with a particular company's proprietary list of substances it bans (and that company is in no way involved in the dealings between us and our customer). Does anyone know where I can get an official list of what substances Sweden bans in electronic products? Thanks as always, Jim Eichner, P.Eng. Manager, Engineering Services Xantrex Technology Inc. Mobile Power web: www.xantrex.com http://www.xantrex.com Any opinions expressed are those of my invisible friend, who really exists and contains reams and reams of brominated flame retardants. Confidentiality Notice: This email message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. --- 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
Domestic 3 meter chamber emissions testing for the world ...
What's the bottom line with Class A emissions testing in a 3 meter chamber in the US for emissions approval anywhere in the world? Does the FCC accept such testing for the US? What about for European CE marking under the EMC Directive? How about Taiwan? How about Japan? Been a while since I've had to deal with this issue. Any input here or offline will be appreciated. Thanks in advance. Regards, Doug McKean --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@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
Fiber Optic Systems
We plan to purchase for resale an LED fiber optic transmitter, receiver and cable that will provide a communications link to our products. While we will resell these devices as optional accesssories for our products, the accessories will retain the original manufacturer's brandname. We will obtain the products from EU based sources, so we will not be involved in inportation. The transmitter is a stand alone product with its own power source. The receiver, on the other hand, is a module that attaches inside our equipment enclosure and receives its power from our equipment; therefore, the fiber optic cable must enter our equipment enclosure. I need to determine: 1) if and how EN60825-2 will apply to any of these accessories - i.e must it appear on any Declaration of Conformity? 2) if my company must issue any Declaration of Conformity that lists EN60825-2. 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...@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: ISO 9k/2k relevance
Hello Brian, I don't have any helpful answers for you. I used to sell ISO 9000 and the majority of times I heard its benefits praised was by my bosses and the sales information. I do remember a small number of customers saying that, for them to be considered in bids, they had to have ISO 9000. However, I have also work for ISO 9000 companies whose day to day working practices were a mess, but come audit day they would come up smelling of roses. I suspect that ISO 9000 / 2000 will improve this situation, and perhaps through time, if customer companies see marked improvements in their own operations, more of them will start to insist on their suppliers having the same accreditation. From personal experience, the companies I have had dealings with are still in a period of transition from the old ISO 9000, and therefore any benefits of the new system are still to be realised. Best regards, David Sproul -Original Message- From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Brian O'Connell Sent: 08 August 2002 15:36 To: Product Safety Technical Committee Subject: ISO 9k/2k relevance Good People of the PSTC: I've had some conversations with our Component Engineers, Sales and QA people. I could not identify any customer that placed an order based on our ISO 9k and/or 2k certification. Nor could I identify any component specified and/or purchased that was based on whether a supplier has ISO certification. Is the ISO paper mill relevant? Is there empirical evidence that ISO certification results in better stuff? Is ISO certification a requirement for your purchasing policies? Has ISO certification been a determining or contributing factor for selection of your company's products? At this point, I am not being critical of the ISO process; I am attempting to understand its ROI and relevance to product quality. I speak only for myself; nothing said here represents my employer's policies. R/S, 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: 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 60825-1, Amendment 2
Tom, Thanks for the reply. After doing some searching on the CENELEC website I was able to confirm that Amendment 2 to EN 60825-1 is harmonized under both the LVD and RTTED with a DOW of 1/1/2004. The CENELEC information also indicates that there are no A-Deviations or Special National Conditions specified for this document, so it should be the same as IEC 60825-1:1993/A2:2001. Regards, R. Meyette At 10:03 AM 8/9/02 +0900, you wrote: On Wed, 07 Aug 2002 17:23:42 -0700, Richard Meyette meye...@pacbell.net wrote: Was Amendment 2 to EN 60825-1 adopted from IEC 60825-1 with no deviations, or do I need to also purchase a copy of this amendment for CE certification? What is the DOW for this amendment? I don't know if EN 60825-1:1994/A2:2001 and IEC 60825-1:1993/A2:2001 are exactly identical or not, although I guess (hopefully) they are. For CE marking, EN 60825-1:1994/A11:1996 and EN 60825-1:1994/A2:2001 are listed as the harmonised standards under the LVD (2002/C 57/01), and date of cessation of presumption of conformity of the superseded standard of the latter is 1.1.2004. Regards, Tom -- Tomonori Sato vef00...@nifty.ne.jp URL: http://member.nifty.ne.jp/tsato/ --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: 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
Looking for EMC Design/SI/Compliance Job
Hello Group, the private company I was with has laid off large number of people due to current market conditions, and I am in position to look for a job. I am located in SF Bay Area. Does anyone know of any opening that would match my experience, which is in the EMC/SI and Compliance area. I pasted the summary of my qualifications below. For more information, I can be contacted offline. Thanks, Neven Pischl npis...@yahoo.com SUMMARY MSEE with 15+ years of EMC and related experience. NARTE certified EMC-Engineer. Design for EMC and PCB-level SI, RD in RF test and measurement methods, setup and manage EMC/Safety group and test facility, working with subcontractors and vendors, providing compliance test plans and working with external test houses. Experience with design for low-noise and high-immunity of various high speed (100 ps) digital, analog, and RF products, and various LAN and WAN interfaces such as 10/100/GBit Ethernet, xDSL, T1/E1, DS3, ISDN, FXS/FXO, IP Telephony/VoIP, OC12, wireless LAN and telephony. Worked in RD, aerospace, consumer electronics, low- end and high-end networking environments. Special interest and profound skills in EMC-design at all product-levels, with emphasis on PCB-level design. Provide detailed instructions for PCB, system, and mechanical design. Familiar with various EMC/Safety/Telecom standards (e.g. EN55022/55024, CFR 47 part 15, NEBS GR1089/63/78, ETSI 300386), how they apply to different products, certification process, and how to design to meet them. Thorough knowledge of RF/MW concepts, theoretical and applied to high-speed digital design, such as transmission lines, signal-propagation and-termination, time-domain reflectometry (TDR), EM-field propagation, antennas, probes, transformers, EM-field and noise coupling, radiation mechanisms, power distribution and design of decoupling/bypassing, shielding and grounding. Use PSPICE, Hyperlynx, LINPAR, EZ-EMC for analysis, Allegro, Visula, and Mentor Graphics for PCB design reviews. Work with EMI-receiver/spectrum analyzer, network analyzer, TDR. Use bench test-methods and have designed test methodologies and probes for efficient troubleshooting. --- 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 60825-1, Amendment 2
On Wed, 07 Aug 2002 17:23:42 -0700, Richard Meyette meye...@pacbell.net wrote: Was Amendment 2 to EN 60825-1 adopted from IEC 60825-1 with no deviations, or do I need to also purchase a copy of this amendment for CE certification? What is the DOW for this amendment? I don't know if EN 60825-1:1994/A2:2001 and IEC 60825-1:1993/A2:2001 are exactly identical or not, although I guess (hopefully) they are. For CE marking, EN 60825-1:1994/A11:1996 and EN 60825-1:1994/A2:2001 are listed as the harmonised standards under the LVD (2002/C 57/01), and date of cessation of presumption of conformity of the superseded standard of the latter is 1.1.2004. Regards, Tom -- Tomonori Sato vef00...@nifty.ne.jp URL: http://member.nifty.ne.jp/tsato/ --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: 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: Are There Any Standards that Apply to Digital Cameras
Hello Oscar, FYI The 6th ed of IEC60065 does not include battery powered product in the scope but the recently published 7th 2001 ed does now include battery powered product...I would stick with the 6th edition as the 7th has not been adopted by many countries yet.I agree with Sam in that if your product connects to a mains connected battery charger then IEC60065 would definitely apply Even if the product does not use a charger and if there are no specific standards for battery powered digital cameras (don't believe there are) you can still use IEC60065 6th ed as it is not excluded in the scope. I would still want to verify safety compliance of my product if I were you. As far as I remember if your product is less than 75Vdc, as outlined in Article 1, your product should not have to legally comply with the LVD in any case and you should be able to legally mark your product based solely on compliance with the EMC Directive.I'd be interested in any information anyone has to the contrary on this subject. regards, John -Original Message- From: Sam Davis [mailto:sda...@ptitest.com] Sent: Thursday, August 08, 2002 2:29 PM To: oover...@lexmark.com Cc: Emc-Pstc Subject: RE: Are There Any Standards that Apply to Digital Cameras UL 6500 - Audio/Video and Musical Apparatus for Household, Commercial, and Similar Use. IEC 60065 - Audio, Video, and Similar electronic Apparatus - Safety Requirements. The UL Standard is based on this, with of course, deviations. I don't have a copy of it at my desk, so I cannot verify that battery-operated audio and video products are listed in the scope, as they are in the UL Standard. If the IEC Standard does not specify battery-operated, but still has the line designed to be fed from the mains or from a SUPLY APPARATUS, supply apparatus being defined as apparatus which takes power from the mains and from which one or more other apparatus are fed, then the camera, if it has a power supply adapter, would fall into the scope. -Original Message- From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of oover...@lexmark.com Sent: Thursday, August 08, 2002 7:17 AM To: emc-p...@majordomo.ieee.org Subject: Are There Any Standards that Apply to Digital Cameras Everyone, Does anyone know of any product safety standards that apply to digital cameras? The simple, personal, AA battery powered type of digital cameras. Thank you. Oscar Overton Ph: 859-232-2284 --- 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 --- 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
