SIST EN 50527-2-1:2017

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

This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016,
Annex A, for workers with implanted pacemakers. It offers different approaches for doing the risk
assessment. The most suitable one will be used. If the worker has other Active Implantable Medical Devices
(AIMDs) implanted additionally, they need 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 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 ISO 14117:2012, Clause 5.

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

La présente Norme européenne fournit la procédure d'évaluation spécifique exigée dans l’Annexe A de l'EN 50527 1:2016, pour les travailleurs porteurs de stimulateurs cardiaques implantés. Elle propose différentes approches pour réaliser l’appréciation du risque. Celle qui convient le mieux est utilisée. Si le travailleur a en plus d’autres dispositifs médicaux implantables actifs implantés, il est nécessaire de les évaluer individuellement.
Le but de cette évaluation spécifique est de déterminer pour des travailleurs porteurs de stimulateurs cardiaques implantés le risque provenant de l'exposition aux champs électromagnétiques sur le lieu de travail. L'évaluation comprend la probabilité d'effets cliniquement significatifs et tient compte à la fois de l'exposition transitoire et de l’exposition de longue durée dans des zones spécifiques du lieu de travail.
NOTE 1 La présente norme ne concerne pas les risques vis-à-vis des courants de contact.
Les techniques décrites dans les différentes approches peuvent aussi être utilisées pour l’évaluation des zones accessibles au public.
La plage de fréquences à observer comprend les fréquences entre 0 Hz et 3 GHz. Au-dessus de 3 GHz, aucune interférence ne se produit avec le stimulateur cardiaque lorsque les limites d'exposition ne sont pas dépassées.
NOTE 2 La justification de la limitation de la plage d'observation à 3 GHz peut être consultée à l'Article 5 de l'ISO 14117:2012.

Postopek ocenjevanja izpostavljenosti delavcev z aktivnimi medicinskimi vsadki elektromagnetnim poljem - 2-1. del: Specifično ocenjevanje delavcev s srčnimi spodbujevalniki

Ta evropski standard določa postopek za specifično ocenjevanje v skladu s standardom EN 50527-1:2016, dodatek A, za delavce z vsajenimi srčnimi spodbujevalniki. Ponuja različne pristope za izvedbo ocenjevanja tveganja, uporabiti pa je treba najprimernejšega. Če delavec dodatno uporablja druge aktivne medicinske vsadke, mora biti ocenjen ločeno.
Namen specifičnega ocenjevanja je določiti tveganje za delavce z vsajenimi srčnimi spodbujevalniki zaradi izpostavljenosti elektromagnetnim poljem na delovnem mestu. Ocena vključuje verjetnost klinično pomembnih vplivov in upošteva tako prehodno kot dolgotrajno izpostavljenost v določenih območjih delovnega mesta.
OPOMBA 1: Ta standard ne obravnava tveganj zaradi kontaktnih tokov.
Tehnike, opisane v okviru različnih pristopov, se lahko uporabijo tudi za ocenjevanje javno
dostopnih območij.
Upoštevani frekvenčni razpon je od 0 Hz do 3 GHz. Nad vrednostjo 3 GHz ne pride do motenj delovanja srčnega spodbujevalnika, če mejne vrednosti za izpostavljenost niso presežene.
OPOMBA 2: Utemeljitev za omejevanje razpona na 3 GHz lahko najdete v standardu ISO 14117:2012, točka 5.

General Information

• Status: Published
• Public Enquiry End Date: 30-Jun-2015
• Publication Date: 13-Mar-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 13.100 - Occupational safety. Industrial hygiene
• ICS: 17.240 - Radiation measurements
• Technical Committee: INIR - Electromagnetic fields in human enviornment
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Mar-2017
• Due Date: 11-May-2017
• Completion Date: 14-Mar-2017
• Directive: 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 agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
• Directive: 2013/35/EU - Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (20th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) and repealing Directive 2004/40/EC
• Mandate: M/351 - Standardisation mandate addressed to CEN, CENELEC and ETSI to develop harmonized standards for the assessment, measurement and calculation of worker's exposure to static magnetic and varying electric, magnetic and electromagnetic fields with frequencies from 0Hz to 300 GHz
• Ref Project: EN 50527-2-1:2016 - 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

Relations

• Replaces: SIST EN 50527-2-1:2011 - 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
• Effective Date: 06-Dec-2016
• Replaces: SIST EN 50527-2-1:2011 - 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
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 50527-2-1:2017
01-april-2017
1DGRPHãþD
SIST EN 50527-2-1:2011
3RVWRSHNRFHQMHYDQMDL]SRVWDYOMHQRVWLGHODYFHY]DNWLYQLPLPHGLFLQVNLPLYVDGNL
HOHNWURPDJQHWQLPSROMHPGHO6SHFLILþQRRFHQMHYDQMHGHODYFHYVVUþQLPL
VSRGEXMHYDOQLNL
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 50527-2-1:2016
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
SIST EN 50527-2-1:2017 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 50527-2-1:2017

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SIST EN 50527-2-1:2017


EUROPEAN STANDARD EN 50527-2-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2016
ICS 11.040.40; 17.240 Supersedes EN 50527-2-1:2011
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 des travailleurs Verfahren zur Beurteilung der Exposition von
porteurs de dispositifs médicaux implantables actifs aux Arbeitnehmern mit aktiven implantierbaren medizinischen
champs électromagnétiques - Partie 2-1: Spécification Geräten (AIMD) gegenüber elektromagnetischen Feldern -
d'évaluation pour les travailleurs avec un simulateur Teil 2-1: Besondere Beurteilung für Arbeitnehmer mit
cardiaque Herzschrittmachern
This European Standard was approved by CENELEC on 2016-07-04. 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, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 50527-2-1:2016 E

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SIST EN 50527-2-1:2017
EN 50527-2-1:2016 (E)
Contents Page
European foreword . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
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 . 15
4.3.1 General . 15
4.3.2 Non-clinical investigation by in vitro testing . 16
4.3.3 Non-clinical investigation by comparative study . 17
5 Documentation . 20
Annex A (normative) Pacemaker specific replacement of EN 50527-1:2016, Table 1 . 21
Annex B (informative) Clinical investigation methods . 27
B.1 External ECG monitoring . 27
B.2 Assessment of pacemaker compatibility using stored data and diagnostic features . 27
B.3 Real time event monitoring by telemetry . 27
Annex C (informative) in vitro testing/measurements . 29
C.1 Introduction . 29
C.2 EM phantom . 29
C.2.1 General . 29
C.2.2 EM phantom design . 29
C.3 Basic procedure for cardiac pacemaker in vitro testing . 30
C.4 References . 31
C.5 Literature . 32
Annex D (informative) Modelling . 33
D.1 General . 33
D.2 Analytical techniques . 33
D.3 Numerical techniques . 33
D.4 Field modelling or calculations . 33
D.5 Modelling the human body and implant . 34
D.6 References . 34
Annex E (informative) Derived worst case conversions for frequencies below 450 MHz . 35
E.1 Introduction . 35
E.2 Functionality of implanted pacemaker leads . 35
E.3 Conversion based on known field strength. 36
E.3.1 General . 36
E.3.2 Low frequency range (below 5 MHz) . 36
E.3.3 Pure magnetic field (16 Hz to 5 MHz) . 37
E.3.4 Pure electric field (16 Hz to 150 kHz) . 39
E.3.5 Field with electric component (16 Hz to 150 kHz) . 42
E.3.6 Field with electric and magnetic component (150 kHz to 5 MHz) . 43
E.3.7 Range between low and high frequency ranges (5 MHz to 30 MHz) . 44
2

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SIST EN 50527-2-1:2017
EN 50527-2-1:2016 (E)
E.3.8 High frequency range (above 30 MHz) . 44
E.4 Conversion based on known compliance with basic restrictions. 46
E.4.1 General . 46
E.4.2 Short survey on the direct effects of human exposure (induced current density) . 46
E.4.3 Short survey on induced voltages on an implanted lead . 48
E.4.4 A simple model to analyse the possible voltages at pacemaker terminations
generated from induced current density equivalent the basic restrictions of Council
Recommendation 1999/519/EC . 48
E.5 References . 50
Annex F (informative) Interference from power-frequency magnetic and electric fields from
transmission, distribution and use of electricity . 52
F.1 Sensitivity of pacemakers to interference . 52
F.2 Immunity requirements . 52
F.3 Voltage induced in the leads by magnetic fields . 53
F.4 Voltage induced in the leads by electric fields . 54
F.5 Values of 50 Hz magnetic and electric field that may cause interference . 56
F.6 Factors that affect the immunity from interference . 57
F.6.1 Reasons for improved immunity . 57
F.6.2 Adjustment for pacemaker sensitivity . 58
F.7 Application to exposure situations . 59
F.7.1 Public exposures . 59
F.7.2 Beneath high voltage power lines . 59
F.7.3 Occupational settings. 60
F.7.4 Temporary exposure above the interference levels . 61
F.8 References . 61
Annex G (informative) Determination of the pacemaker immunity and guidelines provided by
pacemaker manufacturers – Determination method . 62
G.1 Introduction . 62
G.2 EMC and pacemakers – General guidelines . 62
G.3 Induced voltages, fields and zones . 65
G.3.1 Induced voltage test levels . 65
G.3.2 Magnetic field amplitudes producing test limits . 65
G.3.3 Induced voltage zones . 67
G.3.4 Magnetic field zones . 67
G.4 References . 68
G.5 Literature . 69
Bibliography . 70

Figures
Figure 1 — Overview of the assessment process . 9
Figure 2 — Pacemaker 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 . 31
Figure E.1 — Typical implantations of cardiac pacemakers (abdominal implantation with
prolonged lead is used in clinical environment only) . 36
Figure E.2 — Effective induction area of an open wire loop inside a conductive medium . 37
Figure E.3 — Schematic representation of bipolar pickup of interference in an infinitely extended
homogeneous conducting medium . 39
Figure E.4 — Induced voltage on the implanted lead in a pure E field . 41
Figure E.5 — Schematic graphs of the same voltage on the lead for different layouts . 43
Figure E.6 — Eddy-current inside a conductive medium induced by varying magnetic flux . 47
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SIST EN 50527-2-1:2017
EN 50527-2-1:2016 (E)
Figure E.7 — Voltage induced on a lead inside conductive body tissue . 48
Figure E.8 — Voltages on an implanted lead . 50
Figure F.1 — How the immunity ratio affects magnetic field that may result in interference . 58
Figure F.2 — How the immunity ratio affects electric field that may result in interference . 59
Figure G.1 — Induced voltage test levels . 65
Figure G.2 — Magnetic field amplitudes, for frequencies below 5 000 kHz, producing test limits in
unipolar configurations . 66
Figure G.3 — Induced voltage zones for unipolar configurations . 67
Figure G.4 — Magnetic field zones, for frequencies below 5 000 kHz and for unipolar
configurations . 68

Tables
Table A.1 — Compliant workplaces and equipment with exceptions . 21
Table F.1 — Amplitude of the immunity test signal applied . 53
Table F.2 — Values of 50 Hz electric and magnetic field (r.m.s.) that might, under unfavourable
circumstances, cause interference in a pacemaker . 56
Table F.3 — Summary of typical maximum field values beneath high-voltage overhead lines at
1 m above ground . 60

4

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SIST EN 50527-2-1:2017
EN 50527-2-1:2016 (E)
European foreword
This document (EN 50527-2-1:2016) 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 implemented (dop) 2017-07-04
at national level by publication of an identical national
standard or by endorsement
• latest date by which the national standards conflicting with (dow) 2019-07-04
this document have to be withdrawn
This document supersedes EN 50527-2-1:2011.
This document has been prepared under a mandate given to CENELEC by the European Commission and
the European Free Trade Association, and supports essential requirements of EU Directive(s).
EN 50527 is currently composed with the following parts:
— EN 50527-1, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing
active implantable medical devices — Part 1: General;
— EN 50527-2-1, 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;
— prEN 50527-2-2, 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
1)
implantable cardioverter defibrillators .
———————
1) Currently at drafting stage.
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SIST EN 50527-2-1:2017
EN 50527-2-1:2016 (E)
1 Scope
This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016,
Annex A, for workers with implanted pacemakers. It offers different approaches for doing the risk
assessment. The most suitable one will be used. If the worker has other Active Implantable Medical Devices
(AIMDs) implanted additionally, they need 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 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 ISO 14117:2012, Clause 5.
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.
2)
EN 45502-2-1:2003 , Active implantable medical devices — Part 2-1: Particular requirements for active
implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 50413, Basic standard on measurement and calculation procedures for human exposure to electric,
magnetic and electromagnetic fields (0 Hz - 300 GHz)
EN 50527-1:2016, Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices — Part 1: General
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 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 with or without lead(s)
———————
2) The EMC requirements within EN 45502–2-1 have been incorporated with updates into ISO 14117 and their use is recommended
here.
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SIST EN 50527-2-1:2017
EN 50527-2-1:2016 (E)
Note 1 to entry: 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
pacemaker-employee
worker with an implanted pacemaker
Note 1 to entry: For this worker, EN 50527–1 has revealed that a specific assessment following EN 50527–1:2016,
Annex A needs to be done. If this worker bears additionally other AIMD, they need to be assessed separately.
3.7
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
3.8
Holter monitor
Holter ECG monitor
device that continuously records the heart's rhythms
Note 1 to entry: The monitor is usually worn for 24 h – 48 h during normal activity.
Note 2 to entry: The above definition was adopted from NIH (US. 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).
3.9
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
behaviour for which conditions are provided in EN 50527-1:2016, 4.1.3
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EN 50527-2-1:2016 (E)
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 45502-2-1 and ISO 14117, 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 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:
1) 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
2) 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 4.1.2 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 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.
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EN 50527-2-1:2016 (E)
For equipment included in and used per Table A.1
Legend
 History
Un-
Influenced No History
 influenced Further risk assessment is
Behaviour available
1
Behaviour not necessary
Yes
2 3 2
Warning
Specific risk assessment for
from
the pacemaker-Employee is
2
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
3
that this history is sufficient
to exclude clinically
Specific risk assessment for the pacemaker-Employee is
significant interaction
required
Figure 1 — Overview of the assessment process
9

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