EN 50527-2-1:2016

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

Publication date:   Jan 18, 2017

General information

60.60 Standard published   Dec 2, 2016

CENELEC

CLC/TC 106X Electromagnetic fields in the human environment

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics | 17.240   Radiation measurements

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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.

Related legislation

Legislation related to this standard

2013/35/EU

Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and repealing Directive 2004/40/EC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 50527-2-1:2011

NOW

PUBLISHED
EN 50527-2-1:2016
60.60 Standard published
Dec 2, 2016