Dear experts, I was yesterday speaking with one client who is quite desperate. They are producing medical products which contain wifi modules. They have told me, that FDA currently does not accept any such product if no additional testing on wifi module inside the unit are performed. The problem is that I am not aware of what kind of additional tests are required. WIFI module itself is approved component and has necessary certificates.
Health Canada does not have such requirement. Also there are complication if product contains bluetooth module. Is anyone familiar with such requirement? What additional rests need to be performed and which laboratory can perform such testing? Thank you for your support. Best regards, Bostjan - ---------------------------------------------------------------- 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]>
