The FDA does look over the shoulder of pacemaker manufacturers to check their immunity performance. They test to AAMI standards and to their own internal standards, with many of the tests being performed at levels from 100 to 200 Volts per meter.
TUV Product Service in St. Paul MN does a great deal of pacemaker testing, possibly testing more pacemakers each year than any other lab. Also, some EMC consultants in Minneapolis are very familiar with pacemaker testing issues. Paul Cook NARTE Certified EMC Engineer Alpha EMC Inc 8540 West River Rd Minneapolis, Minnestoa 55444 Tel # (612)-561-2844 Fax #(612)-561-3400 E-mail [email protected] Specialty - EMC Consulting -----Original Message----- From: WOODS, RICHARD <[email protected]> To: IEEE Group <[email protected]> List-Post: [email protected] Date: Monday, June 21, 1999 10:26 AM Subject: RE: Pacemakers > >Brian, in the EU all pacemakers must comply with the immunity requirements >of EN50061/A1:1995. There are no real requirements in the US. > >Pacemakers must not malfunction when a 1V peak to peak sine signal with a >frequency range of 20 Hz-500 Hz is applied to a tissue interface simulation >circuit connected to the pacemaker. > >In another test, the pacemaker must continue to function normally when a >modulated signal is applied. 2 mVpp, 20 Hz-1 kHz; 2 mVpp X f/1 kHz from 1 >kHz-8 MHz; 16 Vpp, 8 MHz-30MHz. > >If you have some real concerns, Georgia Tech Research Institute can test >your equipment with pacemakers. Contact Jimmy Woody at (404) 894-3535. > ---------- > From: Brian At Work [SMTP:[email protected]] > Sent: Friday, June 18, 1999 4:01 PM > To: IEEE Group > Subject: Pacemakers > > How do I know if a product MIGHT interfere with a Pacemaker or not? >What types of emissions and levels are Pacemakers sensitive to? Does a >product evaluation check list exist to help determine this. > > I know nothing about Pacemakers. BTW, we manufacture laboratory and >IT equipment. > > Thank you, > Brian > >--------- >This message is coming from the emc-pstc discussion list. >To cancel your subscription, send mail to [email protected] >with the single line: "unsubscribe emc-pstc" (without the >quotes). For help, send mail to [email protected], >[email protected], [email protected], or >[email protected] (the list administrators). > > > --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators).
