UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

- Trained on our vast library of engineering resources.

NEN-EN 50527-2-3

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

active, Most Current
Organization: NEN
Publication Date: 1 November 2021
Status: active
Page Count: 110
ICS Code (Radiation measurements): 17.240
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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 nonimplantable 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

Document History

NEN-EN 50527-2-3
November 1, 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
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...
December 1, 2019
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
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...

References

Advertisement