DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 50527-1
; VDE 0848-527-1:2017-12
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General; German version EN 50527-1:2016
Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Geräten (AIMD) gegenüber elektromagnetischen Feldern - Teil 1: Allgemeine Festlegungen; Deutsche Fassung EN 50527-1:2016
Overview
This standard contains the German version of the second European Standard EN 50527-1 with requirements for the assessment of workplaces with regard to the safety of persons with active implantable medical devices in electromagnetic fields in the frequency range 0 Hz to 300 GHz. This document, which serves as a horizontal EMF standard for the protection of persons with active implants, is used to implement the European Occupational Safety and Health Directive 2004/40/EC. It supplements the European Standard EN 50499:2008 with specifications for the protection of persons with active implants. The relevant workplaces are divided in uncritical workplaces, which do not need a further assessment due to the presence of equipment with limited field radiation, and in such workplaces, which need a further assessment. The methods for the assessment are specified in this standard. Special electromagnetic environments are described in Annex C. The first step in the risk assessment is to identify workers with active implants. If workers with active implants are identified, then the risk assessment is continued by checking the equipment and facilities present at the workplace. If equipment and/or facilities are present at the workplace that cannot be ruled out from the outset, then it shall be assumed that the values of the electric, magnetic or electromagnetic fields may be too high to ensure that the active implantable medical device will function without interference. In this case, a special assessment shall be carried out in accordance with Annex A of the standard. Depending on the result of the assessment, measures may need to be taken to protect the persons concerned. Information on how to document the risk assessment is also provided. Forms that can be used for this purpose are provided in Annex B. Compared to the previous edition of the standard, the reference to the current edition of the European Occupational Safety and Health Directive 2013/35/EU has been changed. Furthermore, a number of minor changes have been made. 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.
