SSH EN 50527-2-3:2021

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators

Scope

This document provides the procedure for the specific assessment required in EN 50527 1:2016, Annex A, for workers with implanted neurostimulator systems (NS), specifically of the type used for spinal cord stimulation (SCS).
It is recognized that implantable neurostimulators have been developed for a wide variety of clinical applications, however the SCS devices within the scope of this document represent the largest segment of the implantable neurostimulator applications thus far.
NOTE 1 If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they are assessed separately according to EN 50527 1 or other particular standards within the EN 50527 series.
The purpose of the specific assessment is to determine the risk for workers with implanted SCS devices arising from exposure to electromagnetic fields (EMF) at the workplace. The assessment includes the likelihood of clinically significant effects.
NOTE 2 This document does not address risks from contact currents, or the effects upon any associated non-implantable devices (e.g. Patient Programmers).
The techniques described in the different approaches can 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 devices within the scope of this document is expected to occur.
NOTE 3 The rationale for limiting the observation range to 3 GHz can be found in ISO 14708 3 [1].
NOTE 4 Further information concerning the functions of neurostimulator systems can be found at https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Cord-Stimulation.

Related directives

Directives related to this standards.