DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 50527-2-1
; VDE 0848-527-2-1:2012-05
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; German version EN 50527-2-1:2011
Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Geräten (AIMD) gegenüber elektromagnetischen Feldern - Teil 2-1: Besondere Beurteilung für Arbeitnehmer mit Herzschrittmachern; Deutsche Fassung EN 50527-2-1:2011
Overview
This standard contains the German version of the European Standard EN 50527-1:2011 with specifications for assessment of workplaces with regard to safety for persons with pacemakers in electromagnetic fields in the frequency range between 0 Hz to 3 GHz. Above 3 GHz no interferences with the pacemaker are to be expected as long as exposure stays within the limits of 2004/40/EC. This document acting as vertical (product-specific) EMF draft standard for the protection of persons with pacemakers is intended for implementation of the European labour protection guideline 2004/40/EC. It supplements the European Standard EN 50527-1:2010 by specific provisions for protection of the aforementioned persons. A specific risk assessment for workers with pacemakers is necessary if one of the three conditions is met: a) There is equipment at the workplace which is not listed in Table A.1 or used in compliance with the amendments (supplements) of Annex A of this document, and there is no documented history showing that the worker with a pacemaker has been working in this environment for a long time without any influences. b) All equipment at the workplace is given in Table A.1 of this standard; it is also used according to the conditions stated in Annex A, but the worker with a pacemaker has been given a special warning (special warnings) from his/her doctor that the worker's pacemaker might be susceptible to interferences caused by electromagnetic fields. c) There is equipment at the workplace which is either not given in Table A.1 or which is not used in accordance with it or the specifications given in Annex A; there is, however, a documented history showing that the worker with a pacemaker has been working in this environment for a long time, but simultaneously that the worker has been given a special warning. This draft specifies assessment methods. Assessment includes the likelihood of clinically significant effects and takes account of both areas with an unlimited period of residence (long-term exposure) and areas which are only entered for a short time (transient exposure). The process of the assessment method is depicted in the standard in the form of a flowchart. The assessment methods are subdivided into clinical (in vivo) and non-clinical (in vitro) methods. Requirements for the methods and aspects to be observed during the assessment are not given in the standard. A possibility is to measure the induced voltage directly in a body replica or to determine by modelling of the field and upper body including the implanted electrode. Another possibility is to determine the electromagnetic field strengths and the associated voltages induced in the pacemaker electrode either for the entire workplace area of the worker with a pacemaker or only for particular pieces of equipment. Furthermore, the standard describes methods for the determination of the interference immunity of pacemakers which can be compared with the specifications given in EN 45502-2-1:2003. By comparison of the interference immunity with the induced voltages it can be estimated whether there is a risk for the affected persons with pacemakers. Other information on the clinical and non-clinical investigation methods, numerical modelling, interference from power-frequency magnetic, and electric fields from use of electricity is provided in the annexes of this standard. Furthermore, specifications for documentation of the results of the application of this standard are given. The responsible committee is K 764 "Sicherheit in elektromagnetischen Feldern" ("Safety in electromagnetic fields") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE.
