SSH EN 50527-2-1:2011

Proçedura për vlerësimin e ekspozimit ndaj fushave elektromagnetike të punonjësve mbartës të pajisjeve mjekësore të implantueshme aktive - Pjesa 2-1: Vlerësimi specifik për punonjësit me stimulus kardiak

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers

Scope

This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527 1:2010 for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other AIMDs implanted additionally, they have to be assessed separately. The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace. NOTE 1 This standard does not address risks to workers bearing a pacemaker from contact currents. The techniques described in the different approaches may also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the pacemaker occurs when the exposure limits are not exceeded. NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in Clause 5 of ANSI/AAMI PC69:2007.

Related directives

Directives related to this standards.