Hi, can anyone help with application of RED to medical devices? We have a product that is classed as a medical device on which we are now adding a wireless device for transmitting data. The data has no effect on the health of the user. We have ensured that there is no crossover of purpose on the embedded hardware of the device: all wireless activity is taken care of on a separate processor to that of which is taking care of all health functionality of the device and we perform a single fault analysis to confirm no faults crossover.
Common sense would suggest to me that the wireless chip (and associated PCB essentials) should be treated to all elements of the RED, and the rest to the medical regulations. It doesn’t make sense to me to require all of the wireless parts to meet the medical regulations (we are in particular here talking software EN 62304) as they are not contributing to the health aspects of the device. Is there any precedent documentation produced by anyone describing this methodology, or am I thinking about this incorrectly? Many thanks, Julia - ---------------------------------------------------------------- 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>
