NOTE 1 This European Standard does not cover indirect effects caused by non active implants.

NOTE 2 The 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.

NOTE 3 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 and take precedence.

NOTE 4 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 5 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.