DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN 50527-1
; VDE 0848-527-1:2011-01
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General; German version EN 50527-1:2010
Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Geräten (AIMD) gegenüber elektromagnetischen Feldern - Teil 1: Allgemeine Festlegungen; Deutsche Fassung EN 50527-1:2010
Overview
This standard contains the German version of the European Standard EN 50527-1:2010 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 acts as a horizontal EMF-standard for the protection of persons with active implantable medical devices serves the implementation of the European Occupational Safety and Health Directive 2004/40/EC. It supplements the European Standard EN 50499:2008 by specifications for protection of persons with active implantable medical devices. It is intended to supplement EN 50527-1 by further implant-specific standards. 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. Particular electromagnetic environments are described in Annex C. The first step of risk assessment is the identification of the worker with active implantable medical devices. If workers with active implantable medical devices have been identified, risk assessment is continued, by testing available devices and equipment at the workplace. If devices and/or equipment are present at the workplace which are not seen as non-critical a priori, it shall be assumed that the values of the electric, magnetic or electromagnetic fields may be too high to ensure unaffected (disturbance-free) behaviour of the active implantable medical device. In this case, a special assessment in accordance with Annex A shall be performed. Depending on the results of the assessment, possible measures for the protection of the affected person shall be initiated. Furthermore, information for the documentation of the risk assessment is given. The applicable forms are offered for this in Annex B. The responsible Committee is K 764 "Sicherheit in elektromagnetischen Feldern" ("Safety in electromagnetic fields") of the DKE (German Commission for Electrical, Electronic and Informational Technologies) at DIN and VDE.
