Hi, The scope of the MDD (see below) says nothing about whether a device is mobile or not. Please look at IEC 60601-1-1 for systems. This gives examples of what certifications devices need when used in a hospital. i.e. in the patient vicinity.
For the EMC questions, I am sure someone has this information. If you place the device on the market or into service, it must have the CE marking. There is an Annex in the MDD (X) that talks about Clinical Evaluations. You might be able to use this. Ned Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax [email protected] e-mail 2. For the purposes of this Directive, the following definitions shall apply: (a) medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means; -----Original Message----- From: Binnom, Cyril A [mailto:[email protected]] Sent: Friday, April 27, 2001 10:46 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,"
