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]> 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]>
