Standards Development

Scope

This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one will be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they need 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 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 ISO 14117:2012, Clause 5.

Purpose

EN 50527-2-1 requires a revision as a result of the publication in 2019 of revisions to the product standard for pacemakers (ISO 14708-2) as well as the EMC collateral standard for these devices (ISO 14117). In addition, subsequent to the last publication of EN 50527-2-1, additional learnings have occurred during the development of EN 50527-2-2 and EN 50527-2-3. Examples of such learnings include risk indexes, zone charts, and better use of examples illustrating the risk assessment flow. These considerations should be adapted and incorporated into the risk assessment for pacemakers to improve the usability of the standard.