You did not mention the product , but I assume that
IEC 60601-2-47:2012 concerns the basic safety and essential performance of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS so you probably considering such a device. I believe that if it is required to test essential performance, and for thorough the specific type of equipment a patient signal is required, a simulator is what you need to fulfil due diligence. Especially if the device software autonomously draws any pertinent conclusions from the measured signals and the signals are not for visual monitoring only. A classical cardiographic device is basically a DM oscilloscope with a high (assisted) CM suppression: any device that can generate a large CM and extremely small DM voltage simultaneously will do. In no way the testing for the integrity of stored data can be the only compliance criterion here. That said and concluded: I am not fully sure what your device is up to....... Gert Gremmen Van: Silvia Diaz Monnier [mailto:silvi...@inti.gob.ar] Verzonden: dinsdag 28 maart 2017 20:12 Aan: EMC-PSTC@LISTSERV.IEEE.ORG Onderwerp: [PSES] Radiated RF electromagnetic fields immunity test on ambulatory electrocardiographic system Hi, the Radiated RF electromagnetic fields immunity test according to IEC 60601-2-47:2012, 202.6.2.3, makes an addition to IEC 60601-1-2:2007. This addition requires to check that there is no loss of any stored data. But collateral IEC 60601-1-2:2007, on 6.2.1.10 also requires to verify the essential performance is not affected by noise on a waveform in which the noise could interfere the diagnosis, treatment or monitoring. Test setup of IEC 60601-2-47 for that test do not require to simulate the patient signal. Is that correct? If so, why 2-47 makes an addition instead of a replacement. If not, why the test setup do not require to use a patient signal simulator to check essential performance as other particular standards IEC 60601-2-25 or IEC 60601-2-27. That is, taking into account both standards, is it neccesary to check both essential performance and the no loss of storaged data? Or only the no loss of any stored data. Thanks for your help. Best regards, Silvia - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) <http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org> David Heald <dhe...@gmail.com> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
