In message <6.1.0.6.2.20080530132152.038ae...@pop.randolph-telecom.com>, dated Fri, 30 May 2008, Joe Randolph <j...@randolph-telecom.com> writes:
>1) How long has IEC 60601 called out EMC immunity for medical devices? As far as I remember, from the beginning. I did some unofficial editing work on the first edition. > >2) Have the EMC immunity requirements in the Third Edition of IEC 60601 >become more stringent than in previous editions? Canada has apparently >delayed the phase-out of the earlier editions in response to >unspecified complaints from industry regarding new requirements in the >Third Edition. I don't know, but it would not be surprising, and the Canadian events suggest so. Some medical equipment uses high powers, even high-power RF (for electrocautery), and other equipment is extremely sensitive, so immunity is a big issue. > >3) For a device that is used in the home to monitor certain parameters >(such as blood pressure) and report that data to a server via the phone >line, is there some flexibility to classify the equipment as ITE >instead of a medical device? I very much doubt it. And there would be a huge responsibility issue if you called it ITE and then a user was injured. I agree that, **in fact**, the device is not very different from a mouse connected to a computer that is connected to the phone line via a modem. But different people, with different views on 'patient safety' (as opposed to 'user safety'), would be assessing any unfortunate incident. > > >I apologize in advance for asking such basic questions, but I work >mostly with ITE and I know those standards much better. I am less >familiar with the IEC 60601 family of standards. No apology is necessary. -- OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk Either we are causing global warming, in which case we may be able to stop it, or natural variation is causing it, and we probably can't stop it. You choose! John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.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...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
