About a year and a half ago I was on a committe charged with developing immunity standards for implantable pulse generators. At the time the committee was finishing the standard on cell phone disturbances. The next area of interference to be covered were the magnetic fields developed by anti theft devices in stores. There has been a lot of research done on this subject at Georgia Tech I believe, where they have several of these systems all set up and I know several manufacturers had taken device down there to be tested. The committee was an AAMI working group and the FDA was also present on the committee. I don't know about any IEC standards but I believe since all of the major pacemaker manufacturers were present on the committee that they were going to push for it to become an international standard upon completion.
Brodie Pedersen EX TUVPS Employee Nonin Medical Inc. Plymouth MN From: "Price, Ed" <[email protected]> To: "'[email protected]'" <[email protected]>, [email protected] Subject: RE: EN standard for pacemaker immunity Date sent: Tue, 21 Mar 2000 06:29:36 -0800 Send reply to: "Price, Ed" <[email protected]> > > Tim: > > I used to test pacemakers, and they could regularly withstand pulsed fields > of several hundred volts per meter. What type of fields do these antitheft > systems create? Do they have an unusually strong magnetic field? > > Could your friend possibly have a defective implant? I suppose you could > arrange for an immunity test for him. Don't forget to have emergency medical > support on hand, and also a well-worded waiver of liability. > > Ed > > > > > -----Original Message----- > > From: [email protected] [SMTP:[email protected]] > > Sent: Tuesday, March 21, 2000 12:45 AM > > To: [email protected] > > Subject: Re: EN standard for pacemaker immunity > > > > > > Hi everyone, > > > > Except for "official" certification - it is not the standard that is > > the most important. > > > > Consider the field strengths that the person (hence pacemaker) will be > > exposed to. Are the standards realistic or were they created to give a > > MINIMUM level of confidence to some authority? > > > > What are the failure modes of the device and what form of harm would a > > failure cause? > > > > What are the product liability issues of an EMC induced failure? > > > > I have a friend with a pacemaker / defibrillator. He was told that > > this new device would give him a better quality of life than the old > > type. > > > > (No - I will not mention makes) > > > > However, the antitheft devices at the shop doors (here in the UK) > > cause him to be defibrillated! He has not been able to go shopping at > > the local center since his heart attack two years ago. > > > > The makers of the device say that it meets all the standards. His > > surgeon will change it to a different make but requires payment for > > the operation and the device. Nobody will tell him that any new device > > will be able to withstand the fields generated by the antitheft > > systems. > > > > B.T.W. The antitheft systems meet their requirements. > > > > My friend is wondering if he can go to litigation over this issue. > > > > Just a thought for the melting pot. > > > > All the above is a strictly personal view. > > > > Regards > > Tim > > > > > :-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-) > Ed Price > [email protected] > Electromagnetic Compatibility Lab > Cubic Defense Systems > San Diego, CA. USA > 858-505-2780 (Voice) > 858-505-1583 (Fax) > Military & Avionics EMC Services Is Our Specialty > Shake-Bake-Shock - Metrology - Reliability Analysis > :-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-):-) > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Jim Bacher: [email protected] > Michael Garretson: [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > > Brodie Pedersen ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
