One of the things I watch out for is over-testing of new products, because of the cost and time implications. Recently I was asked to comment on the test requirements for a piece of medical gear. Nothing in the technology is new, similar devices have FDA approval, so the goal is to determine a minimum set of tests that will likewise achieve approval. The problem is that a local test lab supplied a quote that basically amounted to saying "Medical device? Kaching!$!", and listed seemingly every test that might possibly apply, with a price to match. Then another test lab was asked if a more modest approach was possible, and they came up with the following:
IEC 60601-1 (General Requirements for Safety) Including all applicable clauses IEC 60601 -1-2 (Collateral Standard: Electromagnetic Compatibility) Including – a) CISPR 11 Class A Group 2 (Conducted and Radiated) b) IEC 61000-3-2 Power Line Harmonics c) IEC 61000-3-3 Power Line Flicker d) IEC 61000-4-2 ESD e) IEC 61000-4-3 Radiated Immunity f) IEC 61000-4- 4 EFT g) IEC 61000-4-5 Surge h) IEC 61000-4-6 Conducted Immunity i) IEC 61000-4-8 Magnetic Immunity j) IEC 61000-4-11 Power Line Dips and Brownouts IEC 60601-2-26 – (Particular Requirements for Safety of Electroencephalographs) Scope of use limited by application of device. IEC 60601-2-40 – (Particular Req. for Safety of Electromyographs and Evoked Response Equipment). Scope of use limited by application of device. This particular equipment uses a pulsed electric field for nerve stimulation of a foot or hand. Operation is contactless, so the patient is fully insulated from the therapy circuitry. To monitor the patient there is a 3 wire EMG sensor that is fully optically isolated and passes hipot and leakage without any trouble. Power draw is under 150W via a standard IEC power cord plugged into a standard safety grounded receptacle. There is a membrane keyboard and VF display for control. All of this is contained in a single box, the EMG leads and power cord being the only cables. Comparing that against the test list, I question, for instance, the inclusion of EEG requirements. One might suppose that the box could be misused by someone placing their forehead against the therapy surface to see if it feels good, but the operation manual proscribes things like that. The basic question here is what can be dispensed with, and what seems to have been left out. I sense that community opinion ranges from a totally barebones approach to fully developed CYA paranoia (in which case the hypothesized off-label experiment might prove beneficial). What think ye? Orin Laney - 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.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 <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
