Hi Paolo, Yes, the 2nd ED has additional requirements but you will need to meet them anyway by November 2004 which is the D.O.W. for the 1st ED of 60601-1-2. In addition, the FDA in the US is now looking for compliance to the 2nd ED. That is, if you claim compliance to the 2nd ED on your 510K then they can not ask you for additional information about EMC. Japan also recognizes the 2nd ED.
With all that being said, you can still use the 1st ED for CE compliance until November 2004. After that date, any MEE shipped into Europe with the CE mark will have to meet the requirements of the 2nd ED if you are going the standards route of compliance to the MDD. I hope this helps. Jim -----Original Message----- From: Paolo Peruzzi [mailto:[email protected]] Sent: Wednesday, January 09, 2002 2:53 AM To: Jim Conrad Cc: [email protected] Subject: RE: EMC for cardio : which standard apply? Jim, thanks for your suggestions. Our product will be sold at least in Europe and US, so we need CE marking, but not only that, I suppose. Though there are some similarities between 60601-2-25 +A1 and 60601-1-2 2nd ed, I think there are important differences too, to the extent that the latter is in general more severe (more tests prescribed). Best regards, p.p. ------------------------------------------------------------- ESAOTE S.p.A. Paolo Peruzzi Research & Product Development Design Quality Control Via di Caciolle,15 tel:+39.055.4229306 I- 50127 Florence fax:+39.055.4223305 e-mail: [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: No longer online until our new server is brought online and the old messages are imported into the new server.
