Cyril, I notice that you deal with EMC approvals. I hope you have a colleague who handles the regulatory and safety aspects of this product, as they may be quite significant.
You describe your product as ITE equipment. If it falls within the scope of the Medical Devices Directive, and can be used in the 'patient vicinity' as defined by EN 60601-1-1 (medical systems), then the product will have to comply with EN 60601-1, the safety standard for medical electrical equipment. 'Regular' ITE equipment almost certainly will not comply with this standard due to the stringent leakage current, spacings and dielectric requirements. Also, depending on the classification of the product, your company may need to have its Quality System approved by a European Notified Body. Regards, Jon Griver Medson Ltd. [email protected] > -----Original Message----- > From: [email protected] [mailto:[email protected]]On > Behalf Of Binnom, Cyril A > Sent: Friday, April 27, 2001 17:46 > 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,"
