Are there alternate medical equipment EMC standards (i.e., 60601-x series) that would give you more leeway?
Mike Sherman Graco Inc. Product Safety and Compliance Engineer ----- Original Message ----- From: "Niels Hougaard" <[email protected]> To: "EMC-PSTC" <[email protected]> Sent: Tuesday, January 20, 2015 1:39:45 AM Subject: [PSES] ISM-use of a non-ISM frequency Dear list members, Product in question is an ISM equipment. Classified according to EN 55011:2009/CISPR 11:2009 as class A, group 1 equipment. Using RF energy for a kind of skin treatment, with a probe at the end of a 1-1,5 m long cable. The EN 55011:2009/CISPR 11:2009 has increased radiation limits at the ISM frequencies, which are listed in table 1, but the product is using a frequency that is not in the table. Product is at stand by when the user is not pressing a button, emission being well under the limits. When the button is pressed, the frequency in use is about 5-15 dB above the limits (radiated/conducted). Also when all realistic means for reducing the emission have been introduced (including a good shielding of the cable, and reducing the power as much as possible). The button is pressed some seconds in periods. Using another frequency for the RF is unfortunately not possible. I think that asking a notified body and/or for a special permission/acceptance is a last chance for being able to CE-mark the product. Do you see others possibilities? Any experiance with such a permission, if at all possible? Regards, Niels Niels Hougaard Bolls ApS · Ved Gadekæret 11F, Slagslunde · DK-3660 Stenløse Tlf. +45 48 18 35 66 · Direkte +45 5379 6991 [email protected] · www.bolls.dk - ---------------------------------------------------------------- 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] > - ---------------------------------------------------------------- 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]>
