Medical equipment shall comply with IEC or EN 60601-1-2 for EMC which calls out CISPR 11 for emissions. This standard currently test the emissions up to 1.0GHz. Now we introduce an approved 2.4/5GHz radio module. For Europe I would re-test the whole system to comply with 301 489-1 and 301489-17 standard for EMC.
>From what I read, the FDA required FCC approval for the radio when there is on >in a medical equipment. Would the documentation in the FCC webpage be enough >or, as in Europe, do I also have to re-test the whole system to comply with >part 15.209? Sincerely, Dieter Paasche - ---------------------------------------------------------------- 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]>
