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.
Calcagnini
Giovanni
G
Dipartimento di Tecnologie e Salute, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. giovanni.calcagnini@iss.it
Censi
Federica
F
Bartolini
Pietro
P
D040421:Cell Phone / Q000592:standards; D017147:Defibrillators, Implantable / Q000592:standards; D004574:Electromagnetic Fields; D004867:Equipment Design; D004868:Equipment Failure; D004864:Equipment and Supplies; D005062:European Union; D017408:Guidelines as Topic; D006268:Health Facilities / Q000592:standards; D006801:Humans; D007390:International Agencies / Q000592:standards*; D008452:Maximum Allowable Concentration; D016272:Occupational Health; D010138:Pacemaker, Artificial / Q000592:standards