Thanks to all who replied on this topic. Ken Javor Phone: (256) 650-5261
From: "Morse, William" <[email protected]> Date: Wed, 8 May 2013 15:36:02 +0000 To: Ken Javor <[email protected]> Conversation: [PSES] What agency/standards control medical device radio frequency immunity in the USA Subject: Re: [PSES] What agency/standards control medical device radio frequency immunity in the USA Hello Ken, Brain is correct however there is more to it. The FDA consensus standards like 60601-1-2 contain certain aspects but the FDA seems to be concentrating on this area recently. The risk file, verification and validation activities need to explain the risks and how they were mitigated when exposed to other device emissions or when operating on the same network with other devices. Compatibility and coexistence testing may need to go beyond what is in the collateral or particular standards in order to gain clearance from the FDA to market. Justifications for why the device manufacture believes the pass/fail criteria is adequate along with how the criteria was chosen, quantified and measured will also need to be provided. Bill From: Ken Javor <[email protected]> Reply-To: Ken Javor <[email protected]> Date: Sunday, May 5, 2013 8:59 PM To: "[email protected]" <[email protected]> Subject: [PSES] What agency/standards control medical device radio frequency immunity in the USA What agency/standards control medical device radio frequency immunity in the USA All, Both medical diagnostic equipment that might be used in a physician's office or hospital setting, plus things like pacemakers which may be embedded in a person with a life-supporting function. Thank you, Ken Javor Phone: (256) 650-5261 - ---------------------------------------------------------------- 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://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 <[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://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 <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
