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Expert Review of Medical Devices Volume 9, 2012 - Issue 3
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Review

Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part II: active implantable medical devices

Eugenio Mattei Department of Technologies and Health, Italian National Institute of Health, Rome, Italy. [email protected]
,
Federica Censi Department of Technologies and Health, Italian National Institute of Health, Rome, Italy
,
Michele Triventi Department of Technologies and Health, Italian National Institute of Health, Rome, Italy
,
Pietro Bartolini Department of Technologies and Health, Italian National Institute of Health, Rome, Italy
&
Giovanni Calcagnini Department of Technologies and Health, Italian National Institute of Health, Rome, Italy
Pages 289-297 | Published online: 09 Jan 2014

References

  • Seidman SJ, Ruggera P, Brockman R, Lewis B, Shein M. Electromagnetic compatibility of pacemakers and implantable cardiac defibrillators exposed to RFID readers. Int. J. Radio Freq. Identif. Technol. Appl. 3, 237–246 (2007).
  • Seidman SJ, Brockman R, Lewis BM et al. In vitro tests reveal sample radiofrequency identification readers inducing clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators. Heart Rhythm 7(1), 99–107 (2010).
  • Pantchenko OS, Seidman SJ, Guag JW et al. Electromagnetic compatibility of implantable neurostimulators to RFID emitters. Biomed. Eng. Online 9, 10–50 (2011).
  • Pantchenko OS, Seidman SJ, Guag JW. Analysis of induced electrical currents from magnetic field coupling inside implantable neurostimulator leads. Biomed. Eng. Online 10(1), 94 (2011).
  • Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC). Active Implantable Medical Device Directive AIMD, Bruxelles, Belgium (1990).
  • prEN 45502-1:2010. Active Implantable Medical Devices – Part 1: General Requirements for Safety, Marking and Information to be Provided by the Manufacturer. Comité Européen de Normalisation Electrotechnique, Brussels, Belgium (2010).
  • EN 45502-2-1:2005. Active Implantable Medical Devices – Part 2–1: Particular Requirements for Active Implantable Medical Devices Intended to Treat Bradyarrhythmia (Cardiac Pacemakers). Comité Européen de Normalisation Electrotechnique, Brussels, Belgium (2005).
  • EN 45502-2-2:2008. Active Implantable Medical Devices: Particular Requirements for Active Implantable Medical Devices Intended to Treat Tachyarrhythmia (Includes Implantable Defibrillators). Comité Européen de Normalisation Electrotechnique, Brussels, Belgium (2008).
  • EN 45502-2-3:2010. Active Implantable Medical Devices: Particular Requirements for Cochlear and Auditory Brainstem Implant Systems. Comité Européen de Normalisation Electrotechnique, Brussels, Belgium (2010).
  • ISO 14708-3:2008 Implants for Surgery. Active Implantable Medical Devices – Part 3: Implantable Neurostimulators. International Organization for Standardization, Geneva, Switzerland (2008).
  • ANSI/AAMI PC69:2007. Active Implantable Medical Devices – Electromagnetic Compatibility – Emc Test Protocols for Implantable Cardiac Pacemakers and Implantable Cardioverter Defibrillators. National Standard Institute/Association for the Advancement of Medical Instrumentation, DC, USA (2007).
  • Mattei E, Calcagnini G, Censi F, Triventi M, Bartolini P. Role of the lead structure in MRI-induced heating: in vitro measurements on 30 commercial pacemaker/defibrillator leads. Magn. Reson. Med. 67(4), 925–935 (2012).
  • Nordbeck P, Weiss I, Ehses P et al. Measuring RF-induced currents inside implants: Impact of device configuration on MRI safety of cardiac pacemaker leads. Magn. Reson. Med. 61(3), 570–578 (2009).
  • Kainz W, Alesch F, Chan DD. Electromagnetic interference of GSM mobile phones with the implantable deep brain stimulator, ITREL-III. Biomed. Eng. Online 2, 11 (2003).
  • Barbaro V, Bartolini P, Calcagnini G et al. On the mechanisms of interference between mobile phones and pacemakers: parasitic demodulation of GSM signal by the sensing amplifier. Phys. Med. Biol. 48(11), 1661–1671 (2003).
  • Dawson TW, Caputa K, Stuchly MA, Shepard RB, Kavet R, Sastre A. Pacemaker interference by magnetic fields at power line frequencies. IEEE Trans. Biomed. Eng. 49(3), 254–262 (2002).
  • Irnich W, Steen-Mueller MK. Pacemaker sensitivity to 50 Hz noise voltages. Europace 13(9), 1319–1326 (2011).

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