EN 50527-2-1:2011

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

Publication date:   Aug 17, 2011

General information

99.60 Withdrawal effective   Jul 4, 2019

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 Annex A of EN 50527 1:2010 for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other AIMDs implanted additionally, they have 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 to workers bearing a pacemaker 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 Clause 5 of ANSI/AAMI PC69:2007.

Related legislation

Legislation related to this standard

2004/40/EC

Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)

Life cycle

NOW

WITHDRAWN
EN 50527-2-1:2011
99.60 Withdrawal effective
Jul 4, 2019

REVISED BY

PUBLISHED
EN 50527-2-1:2016