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  • BSI
    19/30402929 DC BS 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
    Edition: 2019
    $44.66
    / user per year

Description of 19/30402929 DC 2019

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 and takes both transient and long-term exposure within specific areas of the workplace into account. NOTE 2 This document does not address risks from contact currents or the effects upon any associated external devices. 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. 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.

Standard Number19/30402929 DC
TitleBS 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
StatusDefinitive
Publication Date2019-12-06
Identical National Standard OfprEN 50527-2-3
DescriptorsElectromagnetic fields, Personnel, Medical equipment, Risk assessment, Electromagnetic radiation
ICS11.040.40 Implants for surgery, prosthetics and orthotics, 13.100 Occupational safety. Industrial hygiene, 13.280 Radiation protection, 17.240 Radiation measurements
CommitteeGEL/106
PublisherBSI
Pages73

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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