Hi Matthew, Seem that your interpretation is correct. You need 2-25. 2-27 is for monitoring units. If your device do this (for all biological signals specified in your message) you can use this standard. 2-25 consists on the previous 2-25 + 2-51 (which was for interpretation of ECG). Especially, if your product is a SW for processing the records of the specified biological signals (collected by other parts of the system) for ECG signals you need to use 2-25. For the other signals your SW need to treated as a whole in the Risk Management File of the system and for all system need to be validated and for the life cycle apply IEC 62304. I hope that the above can help.
Best Regards and Be Safe, Steli Steli Loznen, M.Sc., SM-IEEE VP for Technical Activities and Member of BoG IEEE-PSES Convener IEC 62A/MT29+MT 62354 17-3 Shaul HaMelech Blvd. Tel Aviv 6436719 Israel Tel:+972-3-6912668 Fax:+972-3-6913988 Mobile:+972-54-4818816 e-mail: [email protected] From: Matthew D. Varas <[email protected]> Sent: Friday, October 30, 2020 9:27 PM To: [email protected] Subject: [PSES] 60601 Electrocardiographs Hello, I am a bit confused about the 60601 particular standard for one of our devices. The previous version of the device had been designed to EC13 back in the stone age and it is being fully redesigned. My confusion is determining which particular is more appropriate, 60601-2-25 or 60601-2-27. The device in question is part of a system records heart rate, blood pressure, and some other parameters and records them in our software. These recordings are analyzed by the software, compared against normative data, and presented to the physician so they can make a diagnosis. We own -2-27 but not -2-25. Reading through -2-27 it feels like it is targeted more toward monitors that would be used in a life-sustaining scenario whereas the abstract for -2-25 specifically mentions "for the production of electrocardiogram reports for diagnostic purposes." I interpret this to mean that -2-25 is the correct particular standard to use for our device. Is my thinking correct? If not, can someone help me understand the differences between the two? Thank you, Matthew Varas Electrical Engineer WR Medical Electronics Co 1700 Gervais Avenue | Maplewood, MN 55109 | U.S.A. Office: 651.604.8473 [email protected]<mailto:[email protected]> - ---------------------------------------------------------------- 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 <[email protected]<mailto:[email protected]>> 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 <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]> 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 <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
