RE: EMC for cardio : wich standard apply?
Hi Paolo, I need more information about where your product will be sold. Will it be sold in Europe (CE marking)? There will be some inconsistencies until the part 2 standards have been updated. In the meantime, if a part 2 standard used a dated reference to the 1st edition (1993) of 60601-1-2 then you may use that edition until it has been updated. 60601-2-25 +A1 uses a dated reference to 60601-1-2 (1993), see subclause 1.3. The emc requirements of 2-25 were drafted form an early draft of the 2nd edition of 60601-1-2 so you will notice a similarity in the requirements. You will not go wrong by using the 2nd edition but you may not be required to do so until 1 November 2004. Best regards, Jim -Original Message- From: owner-emc-p...@majordomo.ieee.org [mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of Paolo Peruzzi Sent: Thursday, January 03, 2002 8:15 AM To: emc-p...@majordomo.ieee.org Subject: EMC for cardio : wich standard apply? hello, I have to test an electrocardiograph for EMC , but I'm in trouble with the standard to apply. There is IEC 60601-2-25 -A1, "Particular requirements for the safety of elecrocardiographs", that deals with EMC, and refers to IEC 60601-1-2 1st ed.(1993, now superseded) and is still valid, as far as I know. But now we have the new edition of IEC 60601-1-2, and its requirements are very different from 60601-2-25-A1 ones. The old edition is replaced by the new one, but what about those particular standards based on it? So I don't know which standard I have to apply. Can anybody out of there dispel my doubts? Best regards p.p. - ESAOTE S.p.A. Paolo Peruzzi Research & Product DevelopmentDesign Quality Control Via di Caciolle,15tel:+39.055.4229306 I- 50127 Florence fax:+39.055.4223305 e-mail: paolo.peru...@esaote.com --- 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org 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. --- 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org 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.
RE: EMC for cardio : wich standard apply?
Paolo, The Medical Devices Directive enforces you to use the standards listed in the Official Journal as follows: Safety: EN60601-2-25 + A1 EMC : EN 60 601-1-2 Any questions, please e-mail or call. This e-mail message may contain privileged or confidential information. If you are not the intended recipient, you may not disclose, use, disseminate, distribute, copy or rely upon this message or attachment in any way. If you received this e-mail message in error, please return by forwarding the message and its attachments to the sender. PETER S. MERGUERIAN Technical Director I.T.L. (Product Testing) Ltd. 26 Hacharoshet St., POB 211 Or Yehuda 60251, Israel Tel: + 972-(0)3-5339022 Fax: + 972-(0)3-5339019 Mobile: + 972-(0)54-838175 -Original Message- From: Paolo Peruzzi [mailto:paolo.peru...@esaote.com] Sent: Thursday, January 03, 2002 3:15 PM To: emc-p...@majordomo.ieee.org Subject: EMC for cardio : wich standard apply? hello, I have to test an electrocardiograph for EMC , but I'm in trouble with the standard to apply. There is IEC 60601-2-25 -A1, "Particular requirements for the safety of elecrocardiographs", that deals with EMC, and refers to IEC 60601-1-2 1st ed.(1993, now superseded) and is still valid, as far as I know. But now we have the new edition of IEC 60601-1-2, and its requirements are very different from 60601-2-25-A1 ones. The old edition is replaced by the new one, but what about those particular standards based on it? So I don't know which standard I have to apply. Can anybody out of there dispel my doubts? Best regards p.p. - ESAOTE S.p.A. Paolo Peruzzi Research & Product DevelopmentDesign Quality Control Via di Caciolle,15tel:+39.055.4229306 I- 50127 Florence fax:+39.055.4223305 e-mail: paolo.peru...@esaote.com --- 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org 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. --- 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: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org 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.
