Seems to be good design requires at least single fault tolerance - which is outside of "normal" functioning.
Sandy CDRH/OSEL/DESE phone number : 301-796-2582 ________________________________ From: Cortland Richmond [mailto:[email protected]] Sent: Friday, December 07, 2012 9:06 AM To: [email protected] Subject: Re: [PSES] The Cost of Safety I was on contract to write a test plan for a new AED when one of the project managers complained about the cost of doing all the tests. "No one else does, it's a competitive disadvantage. Why make it so difficult?" Rather than fall back on "Because you can't legally sell them without," I replied "I don't want to kill people we're trying to save." He went away. In fact, a lot of EMI tests are not immediately critical to the life of a person being treated, but the ambulance still has to be able to hear the dispatcher. Some of them do relate to function; its radio shouldn't shut down treatment*, or an AED's processor decision be mislead by overhead locomotive power at 16 2/3 Hz.** Nor do you want to interfere with aircraft collision avoidance or its communications. So I kept it simple. *Reported to have resulted in death in either a Glen Dash column, or an EMC Club Banana Skins; I forget which. ** www.ncbi.nlm.nih.gov/pubmed/15294405<http://www.ncbi.nlm.nih.gov/pubmed/15294405> Might we have a psychologist speak at an EMC Symposium on "How to talk your boss into doing the right thing"? Cortland Richmond On 12/7/2012 0232, John Woodgate wrote: Safety and EMC 3rd party testing costs are properly a marketing expense, because they are incurred in order to be allowed on to the market. They are not a charge on R&D, because the products work perfectly OK without the testing. - ---------------------------------------------------------------- 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]<mailto:[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]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[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]>
