SIST EN 50527-2-2:2018

SLOVENSKI STANDARD
01-oktober-2018
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Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices - Part 2-2: Specific assessment for workers
with cardioverter defibrillators (ICDs)
Procédure pour l'évaluation de l'exposition des travailleurs porteurs de dispositifs
médicaux implantables actifs aux champs électromagnétiques - Partie 2-2 : Evaluation
spécifique aux travailleurs porteurs de défibrillateurs automatiques implantables
Ta slovenski standard je istoveten z: EN 50527-2-2:2018
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 50527-2-2

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2018
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 2-2: Specific assessment for workers with
cardioverter defibrillators (ICDs)
Procédure pour l'évaluation de l'exposition des travailleurs Verfahren zur Beurteilung der Exposition von
porteurs de dispositifs médicaux implantables actifs aux Arbeitnehmern mit aktiven implantierbaren medizinischen
champs électromagnétiques - Partie 2-2 : Evaluation Geräten gegenüber elektromagnetischen Feldern - Teil 2-2:
spécifique aux travailleurs porteurs de défibrillateurs Besondere Beurteilung für Arbeitnehmer mit Cardioverter-
automatiques implantables Defibrillatoren (ICDs)
This European Standard was approved by CENELEC on 2018-04-03. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 50527-2-2:2018 E
Contents Page
European foreword . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Specific assessment . 8
4.1 Description of the assessment process. 8
4.1.1 General . 8
4.1.2 Equipment consideration . 11
4.1.3 Patient warning consideration . 11
4.1.4 Cases for additional investigation . 11
4.1.5 Choice of investigative method . 14
4.2 Clinical investigation . 15
4.3 Non-clinical investigation . 16
4.3.1 General . 16
4.3.2 Non-clinical investigation by in vitro testing . 16
4.3.3 Non-clinical investigation by comparative study . 19
5 Documentation . 20
Annex A (normative) Device specific replacement of EN 50527-1:2016, Table 1 . 21
Annex B (informative) Clinical investigation methods . 27
B.1 Assessment of device compatibility using stored data and diagnostic features . 27
B.2 Real time event monitoring by telemetry . 27
Annex C (informative) in vitro testing/measurements . 28
C.1 Introduction . 28
C.2 EM phantom . 28
C.2.1 General . 28
C.2.2 EM phantom design . 28
C.3 Basic procedure for device in vitro testing. 29
Annex D (informative) Modelling — Field modelling or calculations . 31
Annex E (informative) Interference from Low-Frequency Magnetic and Electric Fields (1 Hz to
10 MHz) Including Application to 50 Hz Power-Frequency . 32
E.1 Introduction . 32
E.2 Implanted devices and leads . 32
E.3 Sensitivity of devices to interference . 33
E.4 Immunity requirements . 33
E.5 Voltage induced in the leads by magnetic fields . 34
E.5.1 Induction in a loop . 34
E.5.2 Inductive loop area for bipolar leads . 34
E.5.3 Voltage induced in leads . 36
E.6 Voltage induced in the leads by electric fields . 36
E.7 Values of 50 Hz magnetic and electric field that can cause interference . 38
E.8 Factors that affect the immunity from interference . 38
E.8.1 Reasons for improved immunity . 38
E.8.2 Adjustment for device sensitivity setting . 39
E.8.3 Adjustment for lead tip to ring spacing . 41
E.9 Application to Power Frequency Exposure Situations . 42
E.9.1 Public exposures . 42
E.9.2 Beneath high voltage power lines . 42
E.9.3 Occupational settings . 43
E.9.4 Temporary exposure above the interference levels . 43
E.9.5 Induced voltages at occupational exposure limit values . 44
E.10 Conversion based on known compliance with basic restrictions . 44
E.10.1 General . 44
E.10.2 Relationship between magnetic fields and induced current density . 45
E.10.3 Relationship between magnetic fields and induced voltages on an
implanted lead . 46
E.10.4 A simple model to analyse the possible voltages at device terminations
generated from induced current density equivalent the basic restrictions of
Council Recommendation 1999/519/EC . 46
Annex F (informative) Determination of minimum immunity for radio-frequency fields . 49
F.1 Determination of immunity from the field . 49
F.1.1 General . 49
F.1.2 Intermediate frequencies (5 MHz to 30 MHz) . 49
F.1.3 High frequency (above 30 MHz) . 50
F.2 References . 51
Annex G (informative) Obtaining the device immunity and guidelines provided by device
manufacturers – . 52
G.1 Introduction . 52
G.2 EMC and devices – General guidelines, hazards and harms . 52
G.3 Induced voltages, fields and zones . 55
G.3.1 Induced voltage test levels . 55
G.3.2 Magnetic field amplitudes producing test limits . 55
G.3.3 Induced voltage zones . 57
G.3.4 Magnetic field zones . 58
Bibliography . 60

Figures
Figure 1 — Overview of the assessment process . 9
Figure 2 — Specific assessment process . 10
Figure 3 — Additional investigation process . 13
Figure 4 — Comparison process . 18
Figure C.1 — Example of in vitro procedure for EM interference at low frequency using planar
electrodes, bipolar lead and ECG and data recording . 30
Figure E.1 — Typical implantations of cardiac devices . 32
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
homogeneous conducting medium . 35
Figure E.4 — Showing how the immunity ratio affects magnetic field that can result in interference 40
Figure E.5 — Showing how the immunity ratio affects electric field that can result in interference . 40
Figure E.6 — Showing how the tip to ring spacing affects the magnetic field that can result in
interference . 41
Figure E.7 — Showing how the tip to ring spacing affects the electric field that can result in
interference . 42
Figure E.8 — Eddy-current inside a conductive medium induced by varying magnetic flux . 45
Figure E.9 — Voltage induced on a lead inside conductive body tissue . 46
Figure E.10 — Voltages on an implanted lead . 47
Figure G.1 — Induced voltage test levels . 55
Figure G.2 — Magnetic field amplitudes, for frequencies below 10 000 kHz, producing test limits in
bipolar configurations . 56
Figure G.3 — Induced voltage zones for bipolar configurations. 57
Figure G.4 — Induced voltage zones for bipolar configurations. 58
Figure G.5 — Magnetic field zones, for frequencies below 10 000 kHz for bipolar configurations . 59

Tables
Table A.1 — Compliant workplaces and equipment with exceptions . 21
Table E.1 — Values of 50 Hz electric and magnetic field (r.m.s.) that might, under unfavourable
circumstances, cause interference with devices . 38
Table E.2 — Summary of typical maximum field values beneath high-voltage overhead lines and
corresponding voltage induced in the device . 43
Table E.3 a) — Voltage induced in bipolar leads by the health effects ELV where f is in Hz . 44
Table E.3 b) — Voltage induced in bipolar leads by the sensory effects ELV, where f is in Hz. It is
defined only up to 400 Hz . 44

European foreword
This document (EN 50527-2-2:2018) has been prepared by CLC/TC 106X “Electromagnetic fields in the
human environment”.
The following dates are fixed:
• latest date by which this document has to be (dop) 2019-04-03
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) 2021-04-03
conflicting with this document have to be
withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission and
the European Free Trade Association.
1 Scope
This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016,
Annex A, for workers with implanted cardioverter defibrillators (ICDs) and Cardiac Resynchronization
Therapy devices with associated defibrillation functions (CRT-D). Only devices of this type equipped with
leads implanted transvenously are considered. It offers different approaches for doing the risk assessment.
NOTE 1 If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they are
assessed separately according to EN 50527–1 or other particular standards within the EN 50527 series.
NOTE 2 The risks to patients due to interference with pacing functions associated with CRT-D devices are assessed
using EN 50527–2-1.
The purpose of the specific assessment is to determine the risk for workers with implanted ICDs and CRT-Ds
arising from exposure to electromagnetic fields (EMF) 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 3 This standard does not address risks 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 devices
within the scope of this Particular Standard is expected to occur when the exposure limits are not exceeded.
NOTE 4 The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.
NOTE 5 Further information concerning the functions of Pacemakers, CRT-D, and ICD devices can be found in
Ellenbogen and Kaszala, 2014.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
EN 45502-2-2:2008, Active implantable medical devices — Part 2-2: Particular requirements for active
implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
EN 50527-1:2016, Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices — Part 1: General
EN ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
(ISO 14155)
ISO 14117:2012, Active implantable medical devices — Electromagnetic compatibility — EMC test protocols
for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization
devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 50527-1:2016 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 1 to entry: For the purposes of this Particular Standard, the term IMPLANTABLE PULSE GENERATOR describes
any ACTIVE IMPLANTABLE MEDICAL DEVICE that incorporates functions intended to treat tachyarrhythmias.
3.2
implantable cardioverter defibrillator (ICD)
ACTIVE IMPLANTABLE MEDICAL DEVICE comprising an IMPLANTABLE PULSE GENERATOR and
LEAD(S) that is intended to detect and correct tachycardias and fibrillation by application of
CARDIOVERSION/-DEFIBRILLATION PULSE(S) to the heart
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
bipolar lead
lead with two electrodes that are electrically isolated from each other
3.5
AIMD-Employee
worker with an active implantable medical device
Note 1 to entry: For the purposes of this Particular Standard, the term AIMD-Employee refers to the patient whose
implant is of type ICD or CRT-D.
3.6
assessment team
team consisting of:
— employer and if applicable, his occupational health and safety experts and/or occupational physician,
— AIMD-Employee and his responsible physician,
— (technical and medical) experts as necessary, e.g. manufacturer of the device
3.7
implantable cardiac resynchronization therapy/defibrillator device
CRT-D
active implantable medical device intended to detect and correct tachycardias and fibrillation by application
of cardioversion/defibrillation pulses to the heart, and to provide improved ventricular activation to optimize
cardiac output
3.8
anti-tachycardia pacing
ATP
therapy function associated with CRT-D devices consisting of pacing pulses delivered to the heart to
interrupt a tachyarrhythmia episode and restore normal sinus rhythm
3.9
EM phantom
physical model containing tissue-equivalent material used to simulate the body in an experimental dose
measurement (from World Health Organization)
Note 1 to entry: EM phantoms are sometimes also referred to as torso simulator or phantom.
3.10
uninfluenced behaviour
conditions for uninfluenced behaviour are provided in EN 50527-1:2016, 4.1.3
3.11
device
either the implanted ICD or CRT-D device
4 Specific assessment
4.1 Description of the assessment process
4.1.1 General
The risk assessment is based on the approach that, according to EN 45502-2-2 and ISO 14117, ICDs and
CRT-Ds 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 EMF) (see also F.7).
NOTE Throughout the remainder of this standard, the General Public Reference Levels of Council Recommendation
1999/519/EC are referred to as “reference levels” unless specified otherwise.
The EMC requirements within EN 45502–2-2 have been incorporated with updates into ISO 14117 and their
use is recommended here.
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 AIMD-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
AIMD-Employee has received warning(s) from the responsible physician that their device might be
susceptible to electromagnetic interference (EMI), thereby increasing the risk at the workplace. There
are two types of warnings that can be given:
1) patient-specific warnings provided by the responsible physician to the AIMD-Employee due to
settings in effect that can cause changes in device behaviour in the presence of EMF that are below
the reference levels; or
2) general warnings supplied by the device manufacturer in accompanying documentation about
recognized behaviour changes of the device 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 AIMD-Employee does have a history of uninfluenced behaviour while in its
presence, but the AIMD-Employee has received a specific warning as described above.
In order to minimize the burden placed on the employer and AIMD-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 4.1.2 shall apply. When only condition b) exists, then 4.1.3 shall apply.
When condition c) exists, then both 4.1.2 and 4.1.3 shall apply.
When a device is tested according to EN 45502–2-2, 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.
For equipment included in and used per Table A.1 Legend
Un-
Influenced No History
History influenced
Further risk assessment is
Behaviour available
Behaviour
not necessary
Yes
2 3 2
Warning
Specific risk assessment for
from
the AIMD-Employee is
responsible
required
Physician ?
No
2 1 1
further risk assessment
unnecessary if responsible
physician has confirmed
For Equipment not included in or not used per Table A.1
that this history is sufficient
to exclude clinically
Specific risk assessment for the AIMD-Employee is required
significant interaction
Figure 1 — Overview of the assessment process
Figure 2 — Specific assessment process
4.1.2 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 device 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 AIMD-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 4.1.4.
The intent of this clause is to find and utilize information that might already exist and that allows the
assessment to be completed 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 device
manufacturer, equipment manufacturer, employer’s technical department, consultants, or others skilled in
EMI effects with implanted devices.
4.1.3 Patient warning consideration
The responsible physician and AIMD-Employee shall be consulted to determine the type of and details for
any EMI warnings applicable to the device.
If the warning is about behaviour of the device due to interference from particular types of equipment
(see 4.1.1 b) 2)) then it shall first be determined whether that equipment is actually present in the workplace:
• if the equipment is not present, the AIMD-Employee is allowed to work without restrictions and the
specific assessment can be completed and documented as required in Clause 5.
• if the equipment subject to the warning is present, the steps given in 4.1.2 shall be taken.
If the warning is due to the applied settings of the device that might cause reduced immunity (see 4.1.1 b) 1))
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 AIMD-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 AIMD-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 4.1.4.
4.1.4 Cases for additional investigation
When the investigation steps shown in Figure 2 have been followed but fail to mitigate or to dismiss risk to
the AIMD-Employee from the effects of workplace EMI, then an additional investigation shall be performed
as shown in Figure 3 and described in 4.1.5. The goal of the investigation is to determine the likelihood of a
clinically significant response of the device to the EMI at the workplace that is the result of the following.
a) Case 1: Equipment is used at the workplace that is:
1) 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 AIMD-Employee, or
2) capable of emitting fields that can induce device lead voltages exceeding the immunity levels
established by conformity with the device product standard, EN 45502-2-2,
3) known by the device manufacturer to potentially cause interference with the device and there is no
applicable safe use guideline available from other sources.
Figure 3 — Additional investigation process
b) Case 2: The responsible physician has prescribed settings of the device 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 3 and described in 4.1.5 shall be
performed.
4.1.5 Choice of investigative method
4.1.5.1 General
There are two alternative types of investigative methods that may be used:
• clinical (or in vivo) methods directly involving the AIMD-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.
4.1.5.2 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.
NOTE AIMD-Employees who are implanted with a CRT-D device and who are pacing dependent, or who might
otherwise suffer harm from the effects of even temporary EMI are examples of those who might be contraindicated.
A clinical method can only be started with consent of the AIMD-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 AIMD-Employee’s workplace, but this might not be feasible
for a number of reasons. Consideration should be given to whether one of the methods described in Annex B
can be performed while the AIMD-Employee is moving through the workplace or performing the anticipated
job function. Limiting factors can 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 device manufacturer representatives,
• workplace situations and equipment that might offer an EMF environment that varies significantly from
day to day such that the exposure provided during a single test might not represent the likely worst
case, or even typical, exposure values for that AIMD-Employee.
If it is determined that a clinical investigation at the workplace is not feasible, the assessment team should
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 might be
the cause of hazardous EMI to the AIMD-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.
4.1.5.3 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 might already be known. In
this case a comparative approach as outlined in 4.3.2 can be readily attempted,
• the clinical approach is impracticable for any of the other reasons given in 4.1.5.2.
If a determination is made to use 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 shall be carried out in
accordance with national regulation, else with the requirements of EN ISO 14155. Any clinical investigation
shall be performed under the supervision of medical personnel.
NOTE 1 EN ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical
devices.
This investigation may be performed either in the AIMD-Employee’s workplace or in a laboratory setting, as
determined in 4.1.5.2.
High voltage therapy or ATP therapy shall be disabled prior to beginning clinical investigation, and shall be
re-enabled at the conclusion of the investigation. Prior to commencing the investigation, it shall be
determined whether the device incorporates an auto-revert function that could possibly re-enable therapy
during the investigation. If so, the test plan shall include provisions to ensure the safety of the AIMD-
Employee during the investigation.
The assessment team can choose one of the methods described in Annex B. The choice and rationale shall
be documented according to Clause 5.
If the AIMD-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 AIMD-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 AIMD-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 AIMD-Employee. The advantage
of this approach is that it can reveal a boundary of safe exposure and/or duration of transient exposure.
In this case, the residual risk is reduced since the safe exposure conditions are more fully known.
NOTE 2 When available, information about the known range of field levels compared with the actual levels during the
tests can reduce the residual risk.
If the AIMD-Employee’s situation is Case 2, a provocative clinical test might 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
4.3.1 General
There are two methods for the non-clinical investigation:
• in vitro testing, involving the use of a device and lead inserted into an EM phantom suitable for the
frequency range under consideration that is then exposed to the EMF at the workplace;
• comparative study by the employer or device manufacturer. This involves characterization of the EMF at
the workplace (usually performed by the employer or a third party designate) and a prediction of the
effects on the employee’s device through analysis and comparison with device immunity levels.
The following factors should be considered when making the choice of which method of non-clinical
investigation to use:
• If the in vitro method is chosen, it shall be performed in accordance with the requirements of 4.3.2;
• If the Comparative study method is chosen, it shall be performed in accordance with the requirements of
4.3.3 and shown in Figure 4.
4.3.2 Non-clinical investigation by in vitro testing
4.3.2.1 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 device and lead(s) of the same make and model as that implanted in the AIMD-
Employee (as can be obtained from the device manufacturer or the physician);
• a device programmer compatible with the AIMD-Employee’s device capable of device interrogation, with
up-to-date programming software;
• the approximate lead layout as implanted in the AIMD-Employee is known and available.
General information might be available from in vitro studies about the behaviour of a variety of device types
and settings in specific types of EMF. These can contain useful information about the exposure under
consideration. It might be possible to use these results to make conservative judgements about particular
exposure situations. Care should be taken as the specific implantation of the AIMD-Employee is not
necessarily included in the studies.
4.3.2.2 Requirements for in vitro testing
The pre-requisites given in 4.3.2.1 shall be met. The device and lead(s) shall be arranged within an
EM phantom so as to approximate the layout known for the AIMD-Employee. The device shall be
programmed with the same parameters and have the same operating software as that existing for the AIMD-
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 delivery of anti-tachycardia pacing or
capacitor charging, discharging, intended therapy delivery or inhibition of any of these functions;
• means to generate a simulated cardiac signal representative of ventricular tachycardia or ventricular
fibrillation, and a means to couple to the device being tested.
NOTE 1 It is best practice to disable high voltage or ATP therapy during in vitro testing. Not doing so can expose test
personnel to dangerous shocks. Means exist in device programmers to interrogate the actual state of the device during
EMI exposure rendering actual therapy delivery unnecessary.
NOTE 2 Pacing inhibition, rate tracking, or asynchronous pacing effects associated with CRT-D devices can occur
concurrent with testing of high voltage shock or ATP functions, and these effects are covered extensively in EN 50527–2-
1.
• criteria for results observation, recording, and interpretation, including a definition of which effects
should be considered clinically significant for the AIMD-Employee in question;
• provisions for monitoring the device behaviour in the presence of the fields. Since the level of applied
fields can be higher than those specified in the product test standard EN 45502-2-2, care shall be
exercised to prevent irreversible damage to the device that would invalidate test results.
Provocative testing is recommended as the risk to the AIMD-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 device manufacturer.
An example for performing an in vitro test is given in Annex C.
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