EN 50527-1:2010

The scope of this European Standard is to provide a procedure in order to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a workplace. It specifies how to perform a general risk assessment and to determine whether it is necessary to carry out a detailed risk assessment.NOTE1This European Standard does not cover indirect effects caused by non active implants.NOTE2The the risk of human exposure to EMF considered is only due to malfunctioning of AIMD. Possibilities of AIMD contribution to the risk: e.g. local modification of the distribution of EMF produced by external source or production of own EMF are covered by the respective product standards for the AIMD.Based on specific workplace standards it can be determined whether preventive measures/actions must be taken to comply with the provisions of Directive 2004/40/EC. 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.NOTE3The 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 and take precedence.NOTE4Performance 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.NOTE5This 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.