BS EN 50527-2-1:2016 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers

BS EN 50527-2-1:2016

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers

Status : Current   Published : January 2017

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PDF

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HARDCOPY



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.




Standard NumberBS EN 50527-2-1:2016
TitleProcedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers
StatusCurrent
Publication Date31 January 2017
Normative References(Required to achieve compliance to this standard)EN 50413, EN 45502-2-1:2003, EN 50527-1:2016
Informative References(Provided for Information)ISO 14155, EN 60118–4, EN ISO 14155, 1999/519/EC, EN 50499, 2013/35/EU, IEC 60118–4, ISO 14117:2012, ANSI/AAMI PC69:2007
ReplacesBS EN 50527-2-1:2011
International RelationshipsEN 50527-2-1:2016
Draft Superseded By15/30321270 DC
DescriptorsEnvironment (working), Measurement, Pacemakers, Electromagnetism, Occupational safety, Mathematical calculations, Electrical medical equipment, Frequencies, Clinical testing, Electromagnetic fields, Electromagnetic radiation, Electric fields, Human body, Implants (surgical), Risk assessment, Hazards, Physiological effects (human body), Magnetic fields, Electromagnetic compatibility
ICS11.040.40
13.280
17.240
Title in FrenchProcédure pour l'évaluation de l'exposition des travailleurs porteurs de dispositifs médicaux implantables actifs aux champs électromagnétiques. Spécification d'évaluation pour les travailleurs avec un simulateur cardiaque
Title in GermanVerfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Geräten (AIMD) gegenüber elektromagnetischen Feldern. Besondere Beurteilung für Arbeitnehmer mit Herzschrittmachern
CommitteeGEL/106
ISBN978 0 580 89771 9
PublisherBSI
FormatA4
DeliveryYes
Pages74
File Size8.371 MB
Price£274.00


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