scope:

The scope of this European Standard is to provide a particular procedure in order to assess the risk to workers bearing one or more active implantable medical devices (AIMD) from electric, magnetic and electromagnetic fields at a work place. NOTE 1 This standard does not cover indirect effects caused by non active implants. The purpose of this European Standard is to - produce a standardised simple mechanism for assessing possible risks to AIMD users exposed to EMF. - specify how to perform an initial assessment of the levels of exposure to EMF, if necessary including measurements and/or calculations of such levels, to determine whether it is necessary to carry out a detailed risk assessment of EMF exposure and/or to undertake mitigating measures. Based on specific workplace standards it can be determined whether preventive measures/actions must be taken to comply with the provisions of the Directive. The work situation covered is considered to be under normal working conditions including normal operation, maintenance, cleaning and other situations being part of the normal work. The frequencies covered are from 0 Hz to 300 GHz. NOTE 2 The European Parliament and Council Directive 2004/40/EC will be transposed into national legislation in all the EU member countries. It is recommended that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements may have additional requirements that are not covered by this standard. NOTE 3 Performance requirements with respect to active implantable medical devices are excluded from the scope of this standard. These are defined in the relevant particular standards for active implantable medical devices. NOTE 4 This standard is written under mandate M/351 and relates to the exposure limits as specified in the Directive 2004/40/EC which is intended to protect workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields (0 Hz to 300 GHz) during their work. However, this and other directives may include additional measures for the protection of specific groups of workers and/or specific workplaces for which the employer is required to investigate other protective measures as a part of the overall risk assessment.