SIST EN 50527-2-1:2011

SLOVENSKI STANDARD
01-julij-2011
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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
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
Procédure pour l’évaluation de l’exposition des travailleurs porteurs de dispositifs
médicaux implantables actifs aux champs électromagnétiques - Partie 2-1: Spécification
d’évaluation pour les travailleurs avec un simulateur cardiaque
Ta slovenski standard je istoveten z: EN 50527-2-1:2011
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
13.100 Varnost pri delu. Industrijska Occupational safety.
higiena Industrial hygiene
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 50527-2-1
NORME EUROPÉENNE
May 2011
EUROPÄISCHE NORM
ICS 11.040.40; 17.240
English version
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

Procédure pour l’évaluation de l’exposition Verfahren zur Beurteilung der Exposition
des travailleurs porteurs de dispositifs von Arbeitnehmern mit aktiven
médicaux implantables actifs aux champs implantierbaren medizinischen Geräten
électromagnétiques - (AIMD) gegenüber elektromagnetischen
Partie 2-1: Spécification d’évaluation pour Feldern -
les travailleurs avec un simulateur Teil 2-1: Besondere Beurteilung für
cardiaque Arbeitnehmer mit Herzschrittmachern

This European Standard was approved by CENELEC on 2011-05-02. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 50527-2-1:2011 E
Foreword
This European Standard was prepared by the Technical Committee CENELEC TC 106X, Electromagnetic
fields in the human environment.
The text of the draft was submitted to the formal vote and was approved by CENELEC as EN 50527-2-1 on
2011-05-02.
The following dates were fixed:
– latest date by which the EN has to be implemented

at national level by publication of an identical

national standard or by endorsement
(dop) 2012-05-02
– latest date by which the national standards conflicting

with the EN have to be withdrawn
(dow) 2014-05-02
This European Standard has been prepared under Mandate M/351 given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of EC Directive
2004/40/EC.
__________
– 3 – EN 50527-2-1:2011
Contents
1 Scope . 5
2 References . 5
2.1 Normative references . 5
2.2 Regulatory references . 5
3 Terms and definitions . 6
4 Specific assessment . 7
4.1 Description of the assessment process . 7
4.2 Clinical investigation . 14
4.3 Non-clinical investigation . 14
5 Documentation . 19
Annex A (normative) Pacemaker specific replacement of EN 50527-1:2010, Table 1 . 20
Annex B (informative) Clinical investigation methods . 25
B.1 External ECG monitoring . 25
B.2 Assessment of pacemaker compatibility using stored data and diagnostic features . 25
B.3 Real time event monitoring by telemetry . 26
Annex C (informative) In vitro testing/measurements . 27
C.1 Introduction . 27
C.2 EM phantom . 27
C.3 Basic procedure for cardiac pacemaker in vitro testing . 28
C.4 References . 30
C.5 Literature . 30
Annex D (informative) Numerical modelling . 31
D.1 General . 31
D.2 Analytical techniques . 31
D.3 Numerical techniques . 31
D.4 Field modelling or calculations . 31
D.5 Modelling the human body and implant . 32
D.6 References . 32
Annex E (informative) Derived worst case conversions . 33
E.1 Introduction . 33
E.2 Functionality of implanted pacemaker leads . 33
E.3 Conversion based on known field strength. 34
E.4 Conversion based on known compliance with basic restrictions. 43
E.5 References . 47
Annex F (informative) Interference from power-frequency magnetic and electric fields from
transmission, distribution and use of electricity . 49
F.1 Sensitivity of pacemakers to interference . 49
F.2 Immunity requirements . 49
F.3 Voltage induced in the leads by magnetic fields . 50
F.4 Voltage induced in the leads by electric fields . 51
F.5 Values of 50 Hz magnetic and electric field that may cause interference . 54
F.6 Factors that affect the immunity from interference . 54
F.7 Application to exposure situations . 56
F.8 References . 58
Annex G (informative) Determination of the pacemaker immunity and guidelines provided by
pacemaker manufacturers – Determination method . 59
G.1 Introduction . 59
G.2 EMC and pacemakers – General guidelines . 59
G.3 Induced voltages, fields and zones . 62
G.4 References . 64
G.5 Literature . 64
Bibliography . 65

Figures
Figure 1 – Pacemaker specific assessment process 9
Figure 2 – Additional investigation process 12
Figure 3 – Comparison process 17
Figure C.1 – Example of in vitro procedure for EM interference at low frequency using plane electrodes and
ECG and data recording 29
Figure E.1 – Typical implantations of cardiac pacemakers (abdominal implantation with prolonged lead is
used in clinical environment only) 34
Figure E.2 – Effective induction area of an open wire loop inside a conductive medium 35
Figure E.3 – Schematic representation of bipolar pickup of interference in an infinitely extended
homogeneous conducting medium 36
Figure E.4 – Induced voltage on the implanted lead in a pure E field 38
Figure E.5 – Schematic graphs of the same voltage on the lead for different layouts 41
Figure E.6 – Eddy-current inside a conductive medium induced by varying magnetic flux 44
Figure E.7 – Voltage induced on a lead inside conductive body tissue 45
Figure E.8 – Voltages on an implanted lead 47
Figure F.1 – How the immunity ratio affects magnetic field that may result in interference 56
Figure F.2 – How the immunity ratio affects electric field that may result in interference 56
Figure G.1 – Induced voltage test levels 62
Figure G.2 – Magnetic field amplitudes, for frequencies below 5 000 kHz, producing test limits in unipolar
configurations 62
Figure G.3 – Induced voltage zones for unipolar configurations 63
Figure G.4 – Magnetic field zones, for frequencies below 5 000 kHz and for unipolar configurations 63

Tables
Table A.1 – Compliant workplaces and equipment with exceptions 20
Table F.1 – Amplitude of the immunity test signal applied 50
Table F.2 – Values of 50 Hz electric and magnetic field (r.m.s.) that might, under unfavourable
circumstances, cause interference in a pacemaker 54
Table F.3 – Summary of typical maximum field values beneath high-voltage overhead lines 57

– 5 – EN 50527-2-1:2011
1 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.
2 References
2.1 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN 50527-1:2010, Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices – Part 1: General
EN 45502-2-1:2003, Active implantable medical devices – Part 2-1: Particular requirements for active
implantable medical devices intended to treat bradyarrythmia (cardiac pacemakers)
EN 62226-3-1:2007, Exposure to electric or magnetic fields in the low and intermediate frequency range –
Methods for calculating the current density and internal electric field induced in the human body – Part 3-1:
Exposure to electric fields – Analytical and 2D numerical models (IEC 62226-3-1:2007)
2.2 Regulatory references
1999/519/EC: Council Recommendation of 12 July 1999 on the limitation of exposure of the general public to
electromagnetic fields (0 Hz to 300 GHz), Official Journal L 199, 30/07/1999, p. 59 – 70
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
th
agents (electromagnetic fields) (18 individual Directive within the meaning of Article 16(1) of Directive
89/391/EEC), Official Journal L 159, 30/07/2004, p. 1–26

3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 50527-1:2010 and the following
apply.
3.1
implantable pulse generator
IPG
part of the active implantable medical device, including the power supply and electronic circuit, that produces
an electrical output
NOTE For purposes of EN 50527-2-1, the term implantable pulse generator describes any active implantable medical device that
incorporates functions intended to treat cardiac arrhythmias.
3.2
pacemaker
active implantable medical device intended to treat bradyarrhythmias , comprising an implantable pulse
generator and lead(s)
NOTE CRT-P devices (Cardiac resynchronization therapy pacemaker) by their nature behave similar and are covered by this standard.
CRT-P devices are sometimes also called multi-channel pacemakers.
3.3
electrode
electrically conducting part (usually the termination of a lead) which is designed to form an interface with
body tissue or body fluid
3.4
unipolar lead
lead with one electrode
3.5
bipolar lead
lead with two electrodes that are electrically isolated from each other
3.6
reference levels
reference levels for general public exposure to electric, magnetic and electromagnetic fields as specified in
Council Recommendation 1999/519/EC
3.7
pacemaker-Employee
worker with an implanted pacemaker
NOTE For this worker, EN 50527-1 has revealed that a specific assessment following Annex A of EN 50527-1:2010 has to be done.
If this worker bears additionally other AIMD, they have to be assessed separately.
3.8
transient exposure
exposure to electromagnetic fields that is acceptable for pacemaker-Employee because it fulfils the following
requirements:
- the exposure is not constant: it comes to an end or reduces to non influential levels
- the exposure does not damage the pacemaker
- the exposure only leads to acceptable response of the pacemaker based on the advice from the
responsible physician (for example by general guidance or by a specific warning) and/or described in
the documentation accompanying the pacemaker
NOTE Such exposure may be caused by the electromagnetic field being temporary or by the exposed person moving within, or
through, an electromagnetic field. The duration of transient exposure varies widely and can only be determined as the result of the risk
assessment, based on the expected response of the pacemaker to the exposure and the physician’s advice on the acceptability of the
response
– 7 – EN 50527-2-1:2011
3.9
assessment team
team consisting of
- employer and if applicable, his occupational health and safety experts and/or occupational physician,
- pacemaker-Employee and his responsible physician,
- (technical and medical) experts as necessary, e.g. manufacturer of the pacemaker
3.10
Holter monitor
Holter ECG monitor
device that continuously records the heart's rhythms
NOTE 1 The monitor is usually worn for 24 h – 48 h during normal activity.
NOTE 2 The above definition was adopted from NIH (U.S. National Institute of Health). The Holter monitor is named for
Dr. Norman J. Holter, who invented telemetric cardiac monitoring in 1949. Clinical use started in the early 1960s. Numerous medical
publications can be found referring to “Holter”, “Holter monitoring” or often also called “Holter ECG monitoring” (see e.g. PubMed at
http://www.ncbi.nlm.nih.gov/pubmed).
3.11
EM phantom
physical model containing tissue-equivalent material used to simulate the body in an experimental dose
measurement (from World Health Organisation)
NOTE EM phantoms are sometimes also referred to as torso simulator or phantom.
4 Specific assessment
4.1 Description of the assessment process
The risk assessment is based on the approach that, according to EN 45502-2-1, pacemakers are expected
to work uninfluenced as long as the General Public Reference levels of Council Recommendation
1999/519/EC are not exceeded (except for static magnetic fields and for pulsed high frequency
electromagnetic fields) (see also Clause F.7).
Further risk assessment is not necessary if a history of uninfluenced behaviour at the workplace exists and a
responsible physician has confirmed that this history is sufficient to exclude severe (clinically significant)
interaction.
A specific risk assessment for the pacemaker-Employee is required when there is history of influenced
behaviour or one of the following three conditions is fulfilled:
(a) there is equipment present in the workplace that is neither included in, nor used in accordance with
Table A.1;
(b) all equipment at the workplace is listed in Table A.1 (see Annex A) and is used accordingly, but the
pacemaker-Employee has received warning(s) from the responsible physician that the pacemaker may
be susceptible to electromagnetic interference (EMI), thereby increasing the risk at the workplace.
There are two types of warnings that may be given:
i. patient specific warnings provided by the responsible physician to the pacemaker-Employee due to
sensitivity settings in effect that may cause changes in pacemaker behaviour in the presence of
electromagnetic fields (EMF) that are below the reference levels; or
ii. general warnings supplied by the pacemaker manufacturer in accompanying documentation about
recognized behaviour changes of the pacemaker when it is subjected to EMF generated by specific
types of equipment;
(c) there is equipment present in the workplace that is neither included in, nor used in accordance with
Table A.1 and for which the pacemaker-Employee does have a history of uninfluenced behaviour while
in its presence, but the pacemaker-Employee has received a specific warning as described above.
In order to minimize the burden placed on the employer and pacemaker-Employee, the assessment should
begin with the investigation steps shown in Figure 1. The steps to be taken are based upon whether the
specific assessment is the result of an equipment issue or a patient warning issue.
When only condition (a) exists, then 4.1.1 shall apply. When only condition (b) exists, then 4.1.2 shall apply.
When condition (c) exists, then both 4.1.1 and 4.1.2 shall apply.
NOTE When a pacemaker is tested according to EN 45502-2-1, the manufacturer is required to provide a warning to the implanting
physician in the accompanying technical information as to any sensitivity settings available in the device that if used, afford the device
with a reduced immunity to certain types of EMI. A specific warning would only be given to the patient receiving the implant if they were
discharged with one of these settings in effect, or if at follow-up, a change to one of these settings was made for clinical reasons.

– 9 – EN 50527-2-1:2011
Start
**Note:
Pacemaker Specific
See exception for situation of simultaneous
Assessment
equipment and patient warning
(Equipment
(Patient warning
consideration)
consideration)
Non-table 1 Equipment or
Y N
Table 1 use deviations?**
*Note:
Includes all field
Consult with
generating sources
Collect physician /
relevant data for employee:
equipment* Obtain warning
details
(Warning concerning settings)
Sufficient data exists
Is warning about
Y
N
to exclude significant
specific equipment?
interference?
Consult with
N Y
physician about
settings
Sufficient data exists
Is the equipment present
N Y
to restrict work?
in the workplace?
Y N
Can
warned settings be Y
N
avoided?
Change
settings
Work with possible restrictions Work allowed
(case 1) (case 2)
Document the results
Continue Inform employee about:
End
with Additional - Areas for continuous stay
Pacemaker Specific
Investigation - Areas of transient exposure
Assessment
(Fig. 2) - Areas of non-Access
Remind employee of guidelines given with the AIMD

Figure 1 – Pacemaker specific assessment process

4.1.1 Equipment consideration
Information relevant to the equipment or other field generating sources under consideration shall be
collected to answer sufficiently the following two questions:
• can it be determined that clinically significant interference with the pacemaker will not occur as a result of
expected exposure to the equipment under consideration? If so, no further assessment is required and
documentation of the result can proceed, as required in Clause 5;
• can it be determined that the pacemaker-Employee can return to the workplace only with restrictions
placed on the work tasks or areas of access? If so, no further assessment is required and documentation
of the work restrictions can proceed as required in Clause 5.
When neither of these questions can be answered positively, additional investigation, hereafter referred to as
“Case 1”, is required as specified in 4.1.3.
NOTE The intent of this clause is to find and utilize information that may already exist and that allows to conclude the assessment
without further, more costly and time consuming effort. It is recommended that experts who are likely to have such information be
contacted. Examples of such experts are the pacemaker manufacturer, equipment manufacturer, employer’s technical department,
consultants, or others skilled in EMI effects with implanted pacemakers.
4.1.2 Patient warning consideration
The responsible physician and pacemaker-Employee shall be consulted to determine the type of and details
for any EMI warnings applicable to the pacemaker.
If the warning is about behaviour of the pacemaker due to interference from particular types of equipment
(see 4.1 (b) (ii)) then it shall first be determined whether that equipment is actually present in the workplace:
• if the equipment is not present, the pacemaker-Employee is allowed to work without restrictions and the
pacemaker specific assessment can be concluded and documented as required in Clause 5.
• if the equipment subject to the warning is present, the steps given in 4.1.1 shall be taken.
If the warning is due to settings of the pacemaker in effect that may cause reduced immunity (see 4.1 (b) (i))
to EMI that is at or below the reference levels, the responsible physician shall be consulted to determine
whether the settings can be changed to avoid settings that are associated with the warning, thereby restoring
standard immunity levels:
• if it is determined that such a change of settings can be made, the pacemaker-Employee shall be advised
to arrange, through consultation with the responsible physician, for these changes of settings to be made
prior to returning to work. When the change of setting has been completed, the pacemaker-Employee is
allowed to work without restrictions. The results shall be documented as required in Clause 5 and the
assessment is concluded.
• if the settings cannot be changed, then additional investigation, hereafter referred to as “Case 2” is
required as discussed in 4.1.3.
4.1.3 Cases for additional investigation
When the investigation steps shown in Figure 1 have been followed but fail to mitigate or to dismiss risk to
the pacemaker-Employee from the effects of workplace EMI, then an additional investigation shall be
performed as shown in Figure 2 and described in 4.1.4. The goal of the investigation is to determine the
likelihood of a clinically significant response of the pacemaker to the EMI at the workplace that is the result of
the following.
• Case 1: Equipment is used at the workplace that is:
o neither listed in, nor used in accordance with, Table A.1, and for which there is no information
available that allows a pre-determination of safe or restricted work for the pacemaker-Employee, or

– 11 – EN 50527-2-1:2011
o capable of emitting fields that may induce pacemaker lead voltages exceeding the immunity levels
established by conformity with the pacemaker product standard, EN 45502-2-1,
o known by the pacemaker manufacturer to potentially cause interference with the pacemaker and there
is no applicable safe use guideline available from other sources.
• Case 2: The responsible physician has prescribed settings of the pacemaker that make it susceptible to
EMI even from equipment listed in Table A.1.
If one of these cases is valid, an additional investigation as shown in Figure 2 and described in 4.1.4 shall be
performed.
Figure 2 – Additional investigation process

– 13 – EN 50527-2-1:2011
4.1.4 Choice of investigative method
There are two alternative types of investigative methods that may be used:
• clinical (or in vivo) methods directly involving the pacemaker-Employee who is monitored for interference
effects; or
• non-clinical methods based upon a choice of either in vitro or comparative study.
If a chosen method provides insufficient information for the risk assessment, further investigation is
necessary.
4.1.4.1 Considerations in choosing a clinical method
Prior to choosing to use a clinical method (for examples, see Annex B), the foreseeable exposure levels shall
be known and the responsible physician should be consulted to determine if it is contraindicated. If it is
contraindicated, a non-clinical method shall be chosen.
Pacemaker-Employees who are pacemaker dependent, or who may otherwise suffer harm from the effects
of even temporary EMI are examples of those who may be contraindicated.
A clinical method can only be started with consent of the pacemaker-Employee according to national
regulation. When considering the use of a clinical method, a second consideration is the choice of site at
which it should be performed. Generally, the preferred site is the pacemaker-Employee’s workplace, but this
may not be feasible for a number of reasons. Consideration should be given to whether one of the methods
described in Annex A can be performed while the pacemaker-Employee is moving through the workplace or
performing the anticipated job function. Limiting factors may include
• harsh or dirty environments,
• confined spaces,
• inability to provide coincident monitoring by clinical personnel or manufacturer representatives, and their
equipment, possibly due to the specific location or the non-availability of personnel or equipment,
• workplaces consisting of different locations separated geographically or those which are not accessible to
clinicians and / or pacemaker manufacturer representatives,
• workplace situations and equipment that may offer an EMF environment that varies significantly from day
to day such that the exposure provided during a single test may not represent the likely worst case, or
even typical, exposure values for that pacemaker-Employee.
If it is determined that a clinical investigation at the workplace is not feasible, the assessment team may
consider the possibility that the method could be applied in a laboratory setting. At a minimum, the following
two limiting factors should be considered:
• the additional investigation is Case 2, where it is not known which equipment in the workplace may be the
cause of hazardous EMI to the pacemaker-Employee. In such cases it is impractical to bring all possible
workplace equipment to the laboratory for testing;
• the additional investigation is Case 1, involving specific equipment of unknown EMI characteristics, where
the equipment cannot be taken to a laboratory due to considerations of any kind.
If a determination is made to perform a clinical investigation, then one of the methods in Annex B may be
chosen and carried out as described in 4.2.

4.1.4.2 Considerations in choosing a non-clinical method
Alternatively, a non-clinical method may be chosen for the additional investigation, for instance when
• the workplace EMF environment is known to fluctuate significantly from day to day, thereby rendering
additional uncertainty in a single instance of clinical testing,
• the range of field levels associated with the workplace or specific equipment may already be known. In
this case a comparative approach as outlined in 4.3.3 may be readily attempted,
• the clinical approach is impracticable for any of the other reasons given in 4.1.4.1.
If a determination is made to perform a non-clinical method, one of the two methods discussed in 4.3 shall be
chosen.
4.2 Clinical investigation
Once it has been decided to perform a clinical investigation and found to be feasible, it should be carried out
in accordance with national regulation, else with the requirements of EN ISO 14155-1 and EN ISO 14155-2.
NOTE 1 These standards define procedures for the conduct and performance of clinical investigations of medical devices.
This investigation may be performed either in the pacemaker-Employee’s workplace or in a laboratory
setting, as determined in 4.1.4.1.
The assessment team may choose one of the methods described in Annex B. The choice and rationale shall
be documented according to Clause 5.
If the pacemaker-Employee’s situation is Case 1, involving specific equipment, the assessment team should
decide whether to perform the investigation in a provocative or non-provocative manner. The choice shall be
documented and a test plan prepared, reviewed and approved by the assessment team:
• a non-provocative test subjects the pacemaker-Employee to all exposure situations associated with the
equipment that are anticipated to be present during the normal execution of their duties. Such a test
should include closest expected distances and orientations relative to the equipment, as well as a
duration of exposure sufficient to determine whether clinically significant EMI effects should have
occurred.
• a provocative test subjects the pacemaker-Employee to exposure situations that include decreased
distances or longer exposure durations than are anticipated during normal execution of their job duties.
These exposures shall be planned and executed to protect the safety of the pacemaker-Employee.
The advantage of this approach is that it may reveal a boundary of safe exposure and/or a duration of
transient exposure. In this case, the residual risk is reduced since the safe exposure conditions are more
fully known.
NOTE 2 Where available, information about the known range of field levels compared with the actual levels during the tests can
reduce the residual risk.
NOTE 3 If the pacemaker-Employee’s situation is Case 2, a provocative clinical test may not be recommended when exposure to
many items of equipment or areas of access in the workplace would be required.
4.3 Non-clinical investigation
There are two methods for the non-clinical investigation:
• in vitro testing, involving the use of a pacemaker device and lead inserted into an EM phantom suitable
for e.g. the frequency range under consideration that is then exposed to the EMF at the workplace;
• comparative study, involving characterization of the EMF at the workplace and a prediction of the effects
on the employee’s pacemaker through analysis and comparison with pacemaker immunity levels.

– 15 – EN 50527-2-1:2011
The following factors may be considered when making the choice of which method of non-clinical
investigation to use:
• in vitro testing shall be performed using an IPG and leads of the same make and model as those
implanted in the pacemaker-Employee. If the in vitro method is chosen, it should be performed in
accordance with the requirements of 4.3.1;
• a comparative study requires the determination of induced voltages and pacemaker immunity. If the
Comparative study method is chosen, it should be performed in accordance with the requirements of
4.3.2 and shown in Figure 3.
4.3.1 Non-clinical investigation by in vitro testing
4.3.1.1 Determination of in vitro testing feasibility
The following requirements are necessary to perform an in vitro test:
• the workplace environment is such that an EM phantom, device programmer, and test personnel can be
accommodated for the duration of anticipated testing;
• a fully functional pacemaker and leads of the same make and model as that implanted in the pacemaker-
Employee can be obtained from the manufacturer or the physician;
• a device programmer compatible with the pacemaker-Employee’s pacemaker is available and capable of
device interrogation with up-to-date programming software;
• the approximate lead layout as implanted in the pacemaker-Employee is known and available.
NOTE General information may be available from in vitro studies about the behaviour of a variety of pacemaker types and settings in
specific types of electromagnetic fields. These may contain useful information about the exposure under consideration. It may be
possible to use these results to make conservative judgements about particular exposure situations. Care should be taken as the
specific implantation of the pacemaker-Employee is not necessarily included in the studies.
4.3.1.2 Requirements for in vitro testing
The pre-requisites given in 4.3.1.1 shall be met. The pacemaker and leads shall be arranged within an
EM phantom so as to approximate the layout of the lead known for the pacemaker-Employee. The
pacemaker shall be programmed with the same parameters and have the same operating software as that
existing for the pacemaker-Employee.
A test plan shall be prepared that defines the following:
• the exposure situations (orientation, distance and duration) to be used for the testing, whether it is to
evaluate EMI with specific equipment or within workplace areas;
• methods and configurations for testing to detect effects, such as pacing inhibition, rate tracking, or
asynchronous pacing;
• criteria for results observation, recording, and interpretation, including a definition of which effects should
be considered clinically significant for the pacemaker-Employee in question;
• provisions for monitoring the IPG behaviour in the presence of the fields. Since the level of applied fields
may be higher than those specified in the product test standard EN 45502-2-1, care shall be exercised to
prevent irreversible damage to the IPG that would invalidate test results.
For tests with specific equipment, provocative testing is recommended as the risk to the pacemaker-
Employee is not a factor. Safety of the personnel conducting the testing shall still be considered. It is also
recommended that such tests be planned in such a way that the field levels and potential for effects are
increased during the assessment up to the point at which it becomes provocative. This will minimize the
chance of device damage.
The test plan shall be reviewed and approved by assessment team and, where necessary, input obtained
from the pacemaker manufacturer.
An example for performing an in vitro test is given in Annex C.
4.3.2 Non-clinical investigation by comparative study
This method of investigation is described in Figure 3 and is based on the comparison of the induced voltages
on the leads with the voltage immunity at the connectors of the pacemaker.

– 17 – EN 50527-2-1:2011
Start
Comparison
Survey on Survey on
field sources implant and
at workplace its settings
Note: Determination of
immunity and induced voltages
Determine
may be performed sequentially
field parameters
or in parallel
at workplace
by
data from
equipment
manufacturers
Fields
or
Field levels
below reference levels
measurement
Y
all over the workplace
at workplace
or
and not Case 2?
modelling and
calculation
N
or:
Determine
Determine
voltage immunity
induced voltages
at the connectors
on the leads
by
by
data from
measurement
implant
with a portable
manufacturer
body simulator
or
or
modelling of field
measured data
at the workplace
and of the thorax
or
with implanted
EN 45502-2-1
leads
(if applicable)
Compare
induced voltages
Induced voltages on the implanted leads Voltage immunity at the connectors
to
voltage immunity
Induced voltages
Risk Assessment
below voltage immunity
for work areas
N Y
all over the workplace
and effects
?
Work with possible restrictions Work allowed
Document the results
Inform employee about:
End
- Areas for continuous stay
Pacemaker Specific
- Areas of transient exposure
Assessment
- Areas of non-Access
Remind employee of guidelines given with the AIMD

Figure 3 – Comparison process
4.3.2.1 Determination of the induced voltages on the leads
One method is to determine directly the induced voltages by measurement using an EM phantom or by
modelling the field and the thorax with implanted leads included (see example in Annexes C and D).
Another method is to determine the EMF levels and associated induced lead voltages, either throughout the
pacemaker-Employee’s anticipated work areas (Case 2), or that which is associated with specific equipment
(Case 1). In either case, the fields shall be determined through measurement, modelling (see example in
Annex D) or use of pre-existing information for the equipment of concern.
General information on measurement is given in EN 50413. For magnetic induction measurements, a circular
measurement coil with an area of 225 cm will result in realistic values whereas the use of a standard
2 2
100 cm coil and averaging over an area of 225 cm may result in higher values. The distance between the
measuring coil and the surface of the emitting source shall be realistic taking into account that the implanted
lead is buried in the body so that direct contact with the source is not possible.
• for Case 2 situations, the fields shall be determined by performing a workplace survey of all non-
Table A.1 equipment that the pacemaker-Employee may reasonably be expected to encounter or work
with. The scope of the equipment to be measured, modelled or otherwise assessed may be reduced by
application of prior knowledge;
• if the field levels are determined to be below the reference levels and the situation is not Case 2, the
pacemaker-Employee can work without restrictions. The finding shall be documented as required in
Clause 5 and the assessment is concluded;
• if the situation is Case 2 or the fields are found to exceed the reference levels, the next step is to
determine the induced voltages on the leads, either by calculations with worst case conversions (see
examples in Annex E (all frequencies) and Annex F (specifically for power frequencies)) or with specific
conversions derived from a body simulator or by modelling of thorax and leads (see example in
Annexes C and D).
4.3.2.2 Determination of the voltage immunity
The voltage immunity at the connectors of the IPG may be obtained
1. using data obtained:
a. from the pacemaker manufacturer, or
b. from existing mea
...