Dick, 60601-1-2: 2nd ED has gone through significant changes since CD2. The FDIS is at the IEC Central office and will go out for vote May 11th. Publication is scheduled for July.
Best regards, Jim -----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Dick Grobner Sent: Monday, April 30, 2001 11:52 AM To: 'Binnom, Cyril A' Cc: IEEE EMC-PSTC E-Mail Forum (E-mail) Subject: RE: Medical Directive With regards to your questions: Mobile or not does not make a difference. We manufacturer diagnostic equipment and use "off the shelf" PC's to do the number crunching. CE marking on the PC has always been an issue with us. About two years ago I did a PC search regarding CE marked equipment under the MDD - no such luck! I contacted UL in Northbrook and asked the question if they have ever evaluated a PC under UL2601 - no luck! What we have done is used a line isolation transformer for the PC, opto-isolated the RS232 to eliminate any ground loop currents. Test the combination per 60601-1-1. We also assure that the PC's, monitors and printers we re-sell have CE (low voltage directive) with our equipment being CE marked under the MDD. CE marking under the MDD can become quite involved, depending on what you do in your facility you may need to pursue quality certification by a Notified Body (NB). If you already have an NB I would definitely contact them regarding this issue, if you don't I would get one, at least to consult with! With regards to 60601-1-2, there is a second draft of this document. I have a copy which I received from a colleague. If there is a web site for the draft I'm not aware of the address. Perhaps one of the other forum members knows of a site and will share with us! We just tested one of our systems, with the recommendation of our NB we added 61000-4-11 (voltage dips), 61000-3-2 (harmonics), 61000-3-3 (flicker). This addresses some of the changes (additions) coming with 60601-1-2. With regards to EN 55011, we tested group 1, class A. I'm not aware of the Sweden and Germany requirement for class B. With regards to the "demo" equipment. You can distribute to Europe without CE marking, however the unit needs to be clearly labeled as "Demo Use Only" (or similar) and must be used only by your people or your authorized representative / distributor. They must be made aware of any potential harm that may be imposed upon the patient, operator or bystander or the environment (EMI/RFI, landfill waste, etc.). You are still held responsible for your equipment! I hope this sheds some light on your issues, & good luck! -----Original Message----- From: Binnom, Cyril A [mailto:[email protected]] Sent: Friday, April 27, 2001 9:46 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 [email protected] ------------------------------------------- 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on "Virtual Conference Hall,"
