Orin, You don't specify the type of the medical device.
If it's an unintentional radiator, then it's not subject to Part 18 and exempt from Part 15 under clause 15.103. If it's an intentional radiator (including ultrasound equipment), then it's subject to Part 18, but some types are exempt, e.g ultrasound, magnetic resonance. However, medical equipment is also subject to FDA requirements, which generally include compliance with IEC 60601-1-2, which calls out EN 55011 for emissions and various IEC 61000-4-X standards for immunity. There are certain more lenient conditions provided by particular standards for specific types of equipment. For example, IEC 60601-2-36 for lithotriptors (which use a spark gap to create mechanical shock waves), specifies that EMC testing is to be done in standby mode. Such situations occur because the philosophy underlying medical equipment regulation is based on risk management, rather than absolute compliance with standards without regard to the medical benefit of the device. Regards, Jon Griver http://www.601help.com The Medical Device Developers' Guide to IEC 60601-1 From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of o. laney Sent: Thursday, April 01, 2010 9:42 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: medical equipment exemption? A client has a medical device that needs to comply with FCC part 18 limits for radiated emissions. It passes in standby/idle mode but fails by ~12 dB in operating mode, during which it is applying therapy to a patient. The client asserts that this type of medical device does not have to comply with RE limits in operating mode, citing surgical ablation devices as an example of equipment where efficacy trumps EMC. However, they are unable to cite a reference for this assertion. I've checked part 18 without finding this. Did I miss the applicable paragraph, or are they remembering an exemption in a CE standard, or just smoking funny cigarettes? Thanks in advance, Orin - 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.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <emcp...@socal.rr.com> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com> - 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.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <emcp...@socal.rr.com> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
