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,"
