Hi, Per the FDA guidance on EMC http://www.fda.gov/cdrh/ode/638.pdf The limit is 3 V/m. See the page numbered 25 of the document.
Note: This is for general medical equipment! There is a guidance document for incubators http://www.fda.gov/cdrh/ode/incubator.html It references IEC 60601-2-19 and 2-20. 2-19 and 2-20 both require the unit to pass at 3 V/m and to pass or fail safe at 10 V/m. Ned Devine Program Manager III Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 616 248 9671 Phone 616 574 9752 Fax [email protected] e-mail -----Original Message----- From: Ralph Cameron [mailto:[email protected]] Sent: Monday, August 27, 2001 5:33 PM To: Antonio Sarolic; [email protected] Subject: Re: Susceptibility level of medical devices (incubator) - urgent! Antonio: I would say many incubators were manufactured when there were no concerns and the susceptibility was a function of the design and very variable. I have heard they vary from 0.1V/m to 10V/m but don't think there is any set standard. The medical gurus prefer to isolate their equipment by physical barriers and hope that something will not affect them In Canada Health Canada could answer thequestion . In the U.S. I believe its the Food and Drug Administration. Ralph Cameron EMC Consulting and Suppression of Consumer Electronics (After sale). ----- Original Message ----- From: "Antonio Sarolic" <[email protected]> To: <[email protected]> Sent: Monday, August 27, 2001 11:59 AM Subject: Susceptibility level of medical devices (incubator) - urgent! > > Hi > > I need urgent info on susceptibility level of medical electronic devices, > especially baby incubators. Can anyone confirm if it is 1V/m (according to > EU standards)? The EMI source is the GSM BS antenna (900MHz). > > Thanks very much. > Antonio > > Antonio Sarolic, M.S.E.E. > Faculty of Electrical Engineering and Computing > Dept. of Radiocommunications and Microwave Engineering > Unska 3, HR-10000 Zagreb, CROATIA > tel. +385 1 61 29 789, fax. +385 1 61 29 717 > E-mail: [email protected] > > > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Michael Garretson: [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: > No longer online until our new server is brought online and the old messages are imported into the new server. > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [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: No longer online until our new server is brought online and the old messages are imported into the new server. ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [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: No longer online until our new server is brought online and the old messages are imported into the new server.
