Electromagnetic immunity of medical devices: the European regulatory framework.

In this paper, the international standards and the European Regulation on medical devices are discussed, with particular attention to the collateral standards and the particular standards concerning the electromagnetic compatibility and immunity of medical devices. In addition, recommended guidelines to be used by health care organizations to assess the immunity of medical devices to radiated electromagnetic fields from portable radio frequency transmitters are indicated and discussed. As far as electromagnetic immunity of active implantable devices are concerned, the difference between United States and European Union (EU) regulatory frameworks is presented (standard ANSI/AAMI PC69:2000 for US and EN45502-1 framework in EU). Finally, some considerations on how to address the risk assessment of workers with implanted devices are discussed.

[1]  D L Hayes.  Wireless Phones and Pacemaker Interaction , 1996, Pacing and clinical electrophysiology : PACE.

[2]  C. Goodman.  Association for the Advancement of Medical Instrumentation , 1988 .

[3]  A. Ahlbom.  Guidelines for limiting exposure to time-varying electric, magnetic, and electromagnetic fields (up to 300 GHz) , 1998 .

[4]  P S Ruggera,et al.  In vitro testing of pacemakers for digital cellular phone electromagnetic interference. , 1997, Biomedical instrumentation & technology.

[5]  R. A. Stevenson.  Design and application of broadband ceramic feedthrough capacitor EMI filters to cardiac pacemakers and implantable defibrillators , 1997, Proceedings of the 19th Annual International Conference of the IEEE Engineering in Medicine and Biology Society. 'Magnificent Milestones and Emerging Opportunities in Medical Engineering' (Cat. No.97CH36136).

[6]  Roger G. Camillo,et al.  Electromagnetic filters impede adverse interference of pacemakers by digital cellular telephones , 1996 .

[7]  V Barbaro,et al.  Do European GSM Mobile Cellular Phones Pose a Potential Risk to Pacemaker Patients? , 1995, Pacing and clinical electrophysiology : PACE.

[8]  H. S. Osborne,et al.  The international electrotechnical commission , 1953, Electrical Engineering.

[9]  V Barbaro,et al.  Electromagnetic Interference of Digital and Analog Cellular Telephones with Implantable Cardioverter Defibrillators: In Vitro and In Vivo Studies , 1999, Pacing and clinical electrophysiology : PACE.

[10]  A Liebrich,et al.  Is there a risk for interaction between mobile phones and single lead VDD pacemakers? , 1996, Pacing and clinical electrophysiology : PACE.

[11]  W. Irnich,et al.  Electromagnetic Interference of Pacemakers by Mobile Phones , 1996, Pacing and clinical electrophysiology : PACE.

[12]  ANDREAS WILKE,et al.  Influence of D‐Net (European GSM‐Standard) Cellular Phones on Pacemaker Function in 50 Patients with Permanent Pacemakers , 1996, Pacing and clinical electrophysiology : PACE.

[13]  Claus Schmitt,et al.  Do airport metal detectors interfere with implantable pacemakers or cardioverter-defibrillators? , 2003, Journal of the American College of Cardiology.

[14]  HARRY G. MONO,et al.  The Safety of Digital Mobile Cellular Telephones with Minute Ventilation Rate Adaptive Pacemakers , 1996, Pacing and clinical electrophysiology : PACE.