摘要：In this paper, the international standards and the European Regulation on medical
devices are discussed, with 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.
关键词：medical devices, equipment and supplies, directives, reference standards, electromagnetic compatibility
