Hi, This is probably a FDA 510(k) requirement for the Anesthesiology group. See web site below for the FDA guidance document. http://www.fda.gov/cdrh/ode/638.pdf
Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: [email protected] www.entela.com From: [email protected] [mailto:[email protected]] On Behalf Of Valentyik, Peter I (MED) Sent: Wednesday, May 12, 2004 11:16 AM To: [email protected] 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 This message is confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. 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
