I don't think my first reply went out. This a second try. Sorry Cyril. Best regards,
Jim Cyril, Please see my answers to your questions below: -----Original Message----- From: [email protected] [mailto:[email protected]] On Behalf Of Binnom, Cyril A Sent: Friday, April 27, 2001 7:46 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. I your device does not have a PATIENT APPLIED PART, you do not have medical electrical equipment and do not have to comply with 60601-1. However, you must ensure that it does not get used in the PATIENT vicinity, i.e. within 1.5 meters of the patient (see Figure 201 in IEC 60601-1-1) You may have a Medical System if this device attaches to Medical Electrical Equipment in which case IEC 60601-1-1 will apply. The software should comply with 60601-1-4. * Will EN 60601-1-2 (EMC) 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. IEC 60601-1-2: Second edition will be published in July. Completely new. Uses 61000-4-XX for immunity. New test levels. Harmonics requirements. Exclusion for ITE, etc. * 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. The hospital environment is considered Class A. Sweden has finally agreed. Germany has always accepted Class A in the Hospital. Check clause 4 of CISPR 11. * 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. You MUST have the CE mark if you plan to show it in an EU country. Best regards, Jim 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,"
