Peter, I know its difficult to argue with some regulatory authorities, but I think you have to turn the question around and ask the body requesting testing to Mil-Std-462 to justify their request. On what regulations are they basing their request?
IEC 60601-1-2 : 2001, which calls out CISPR 11 (EN 55011) for radiated emissions, is a harmonised standard under the Medical Devices Directive in the EU, and is recognized as a 'consensus standard' by the FDA. I know that the FDA reserves the right to have different or additional requirements (including Mil-Std's), but I don't see why you can't request a justification for requirements beyond a consensus standard. If they are able to provide documented requirements, you may find it very difficult to avoid the testing. Regards, Jon Griver http://www.601help.com The Medical Device Developer's Guide to IEC 60601-1 From: "Valentyik, Peter I (MED)" <[email protected]> To: <> Sent: Wednesday, May 12, 2004 6:15 PM Subject: Mil-Std-462D & EN55011 > > We recently received compliance certification for a medical device from an accredited test lab for EN55011. The requirements are to test the device for radiated electromagnetic emissions at high frequencies. We have had requests as to why the Mil-Std-462, RE101 was not tested. The Mil-Std applies requirements at low frequency from 30Hz up to 30Khz. Does anyone have suggested rationale to why we should be able to justify that testing to EN55011 is sufficient and that testing to the Mil-Std is not a requirement anymore? From my understanding, it may only apply to pulmonary type medical devices. Any input is appreciated. > > Thanks > Peter Valentyik. > This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ieee-pses.org/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
