The New Directive 2013/35/EU on Occupational Exposure to

Electromagnetic Fields and Electrical Workers’ Use of Cardiac

Pacemakers

Leena Korpinen

, Rauno Pääkkönen

, Martine Souques

and Vesa Virtanen

Environmental Health, Tampere University of Technology, Tampere, Finland

Finnish Institute of Occupational Health, Tampere, Finland

EDF – DRH Groupe, Paris, France

The Heart Center, Tampere University Hospital, Tampere, Finland

Keywords: Pacemaker, Worker, Directive.

Abstract: The aim of this paper was to investigate, the new directive 2013/35/EU on occupational exposure to

electromagnetic fields and the electrical workers’ use of cardiac pacemakers (PMs). The directive includes

minimum requirements for the protection of workers from risks to their health and safety. In addition there

is information about medical implants, e.g., cardiac pacemakers and possible interference problems. In this

paper we describe our earlier studies of PMs and analyze where it is possible to find such high electric or

magnetic fields that the exposure can influence the PM. Based on experiments at Tampere University of

Technology, the electric field under 400 kV power line may disturb a PM, when the electric field is below

the low action level (10 kV/m). The risk of disturbances is not considered to be high, because only one of

the several PMs showed a major disturbance.

1 INTRODUCTION

The Directive 2013/35/EU of the European

Parliament and of the Council on the minimum

health and safety requirements regarding the

exposure of workers to the risks arising from

physical agents (electromagnetic fields) was

published in 2013. The directive (2013/35/EU)

includes minimum requirements for the protection

of workers from risks to their health and safety

arising, or likely to arise, from exposure to

electromagnetic fields at their work.

When the frequency is 50 Hz, the action levels

(ALs, workers) of the directive regarding magnetic

fields are as follows: low ALs 1,000 µT (rms), high

ALs 6,000 µT (rms), ALs 18 mT (rms) for exposure

of limbs to a localized magnetic field and to electric

fields, and low ALs 10 kV/m (rms), and high ALs

20 kV/m (rms) (European Parliament and Council,

2013). The exposure limit value (ELV) for health

effects, which is related to electric stimulation of all

peripheral and central nervous system tissues in the

body, is 1.1 V/m (peak) to 50 Hz, and the sensory

effects ELV, which is related to electric field effects

on the central nervous system in the head, is

0.14 V/m (peak) (European Parliament and Council,

2013).

The directive also includes information about

medical implants, e.g., cardiac pacemakers and

defibrillators, cochlear implants, and other implants

or medical devices worn on the body. According the

directive 2013/35/EU, it is possible that interference

problems, especially with pacemakers, may occur at

levels below the ALs (European Parliament and

Council, 2013).

The directive includes the list of ‘indirect

effects’, which means effects caused by the presence

of an object in an electromagnetic field. Those may

become the cause of a safety or health hazard, such

as interference with medical electronic devices,

including cardiac pacemakers and other implants or

medical devices worn on the body. (European

Parliament and Council, 2013).

According to the directive, when carrying out the

risk assessment pursuant to Article 6(3) of Directive

89/391/EEC, the employer shall give particular

attention to the following, e.g., interference with

medical electronic equipment and devices, including

cardiac pacemakers and other implants or medical

249

Korpinen L., Pääkkönen R., Souques M. and Virtanen V..

The New Directive 2013/35/EU on Occupational Exposure to Electromagnetic Fields and Electrical Workers’ Use of Cardiac Pacemakers.

DOI: 10.5220/0004913602490252

In Proceedings of the International Conference on Biomedical Electronics and Devices (BIODEVICES-2014), pages 249-252

ISBN: 978-989-758-013-0

 2014 SCITEPRESS (Science and Technology Publications, Lda.)

devices worn on his or her body. (European

Parliament and Council, 2013).

European Committee for Electrotechnical

Standardization (CENELEC) has also published

some standards from this area (CENELEC 2010,

2011). For example, European Norm 50527-1,

according to which magnetic ﬂux density of 100 µT,

is considered to be the ‘safety level’ for pacemakers.

In western countries, persons with cardiac

pacemakers represent a large group. In Finland,

about 700 recipients out of a million inhabitants

received a cardiac pacemaker (PM) in 2010. A PM

is a medical device with electrodes. The electrode

configuration in cardiac PMs can be unipolar or

bipolar. In the unipolar system, the electrode

configuration of the PM includes one electrode that

lies within the heart as a cathode, whereas the anode

is the metallic case of the PM itself, and in the

bipolar system, one lead has two electrodes very

close within the heart. (Chiara et al., 2007)

The aim of this paper was to investigate, the new

directive 2013/35/EU on occupational exposure to

electromagnetic fields and the electrical workers’

use of cardiac pacemakers.

In addition we describe our earlier studies of

PMs and analyze where it is possible to find such

high electric or magnetic fields that the exposure can

influence on the PM (Korpinen et al., 2012,

Korpinen et al., 2013a, Korpinen et al., 2013b).

2 METHODS

2.1 A Human-shaped Phantom

We used a human–shaped phantom for testing PMs

under 400 kV power lines or at 400 kV substations.

The phantom was made out of a commercial plastic

mannequin. In tests, it was filled with 0.9% saline

solution. The height of the water-tight, human-

shaped phantom is 1.92 m. Figure 1 shows a

pacemaker inside the phantom.

Figure 2 shows the phantom under the power

line. Details of the phantom were described in the

previous publication (Korpinen et al., 2012).

2.2 Electric and Magnetic Field

Measurements

Figure 3 shows an example of magnetic field

measurement.

The the electric field was measured at the height

of 1.7 m with an EFA-300 meter (Narda Safety Test

Figure 1: A pacemaker inside the phantom.

Figure 2: The phantom under the power line.

Solutions GmbH, Pfullingen, Germany) (accuracy

± 3%, RMS), and the magnetic field was measured

with a Narda ELT-400 meter (L-3 Communications,

Narda Safety Test Solutions, Hauppauge, NY, USA;

accuracy ± 4% RMS).

Figure 4 shows an example of the electric field

measurement.

BIODEVICES2014-InternationalConferenceonBiomedicalElectronicsandDevices

250

Figure 3: An example of magnetic field measurement.

Figure 4: An example of electric field measurement.

2.3 Tested PMs

The PMs were tested as the following: (1) 31 PMs

were tested near 400 kV power line, and (2) 7 PMs

were tested at a 400 kV substation in two locations.

Details of the test environments and tested

pacemakers were described in the previous

publication (Korpinen et al., 2012, Korpinen et al.,

2013a, Korpinen et al., 2013b).

2.4 Protocol

The protocol of the experiment was so that we used

the phantom in the following ways: (1) isolated from

the ground, (2) grounded from a foot, (3) grounded

from a hand. Details of the measurement system

were described in the previous publication

(Korpinen et al., 2012).

3 RESULTS

Altogether, 31 PMs were tested near 400 kV power

lines. There, the electric field was 6.7–7.5 kV/m and

the magnetic field 2.4–2.9 μT. At a 400 kV

substation, 7 PMs were tested. In location A, the

magnetic field was over 1000 μT, and in location B,

the magnetic field was over 600 μT.

Near the power lines, one of the tested PMs in

the unipolar configuration entered a safety function

with a constant pace of 60 beats per minute. In the

bipolar configuration, however, the same PM

showed no disturbance. During our tests, other PMs

showed minor disturbances or none at all. (Korpinen

et al., 2012)

The magnetic field exposure at the 400

substation did not disturb the PMs (whether in

unipolar or bipolar configuration). (Korpinen et al.,

2013b)

4 DISCUSSION

4.1 Comparison to Exposure Levels at

PM Tests to Occupational

Exposure

In the earlier study (Korpinen et al., 2011b) the

occupational exposure to electric and magnetic

fields was studied during various work tasks at

switching and transforming stations of 110 kV (in

some situations 20 kV). The electric (n = 765) and

magnetic (n = 203) fields were measured during

various work tasks. The average values of all

measurements were 3.6 kV/m and 28.6 µT.

The maximum value of electric fields was

15.5 kV/m. In one special work task close to shunt

reactor cables (20 kV), the highest magnetic field

was 710 µT.

In addition at 400 kV substations the

occupational exposure to electric fields was studied.

The maximum inhomogeneous electric field was 47

kV/m (Korpinen et al., 2009, 2011a).

When we compare the electric field exposure at

PM tests to the electric fields at the 110 kV or 400

kV substations, it is possible to find such a high

electric field as was in the PM tests.

Therefore it is possible that a PM disturbance can

occur at tasks under 400 kV power lines or at

110 kV (or higher) substations.

In the directive 2013/35/EU the action levels (at

50 Hz) are to electric fields: low ALs 10 kV/m

(rms), and high ALs 20 kV/m (rms). Based on the

PM tests, it is possible to find PM disturbances,

when the electric field is below low ALs. It is

essential to take into account in the future if an

TheNewDirective2013/35/EUonOccupationalExposuretoElectromagneticFieldsandElectricalWorkers'Useof

CardiacPacemakers

251

electrical worker will start to use a PM.

5 CONCLUSIONS

It is important to analyze the possible interference

with medical electronic devices, including PMs and

other implants, based on the new directive

2013/35/EU of the European Parliament and of the

Council on the minimum health and safety

requirements regarding the exposure of workers to

the risks arising from physical agents

(electromagnetic fields). In the PM tests at TUT the

electric field under 400 kV power line may disturb a

PM, when the electric field (6.7–7.5 kV/m) is below

low ALs (10 kV/m, at Directive). However the risk

of disturbance is not considered to be high, because

only one of the several PMs showed a major

disturbance.

ACKNOWLEDGEMENTS

Acknowledgments: The assistance of the staff of the

Department of Energy and Process Engineering,

Environmental Health, Tampere University of

Technology (Markus Annila, Tero Haapala, and

Markus Wirta) is gratefully acknowledged. We

thank Harri Kuisti and Jarmo Elovaara (Fingrid Oyj)

for their advice and Hiroo Tarao (Department of

Electrical and Computer Engineering, Kagawa

National College of Technology, Japan) for his

advice and help with the measurements. In addition,

we thank Seppo Malinen (WL-Medical Oy) for

making programming devices available.

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