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)

This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527 1:2015 for workers with implanted cardioverter defibrillators. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they have to be assessed separately.

Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Geräten gegenüber elektromagnetischen Feldern - Teil 2-2: Besondere Beurteilung für Arbeitnehmer mit Cardioverter-Defibrillatoren (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

Postopek ocenjevanja izpostavljenosti delavcev z aktivnimi medicinskimi vsadki elektromagnetnim poljem - 2-2. del: Specifično ocenjevanje delavcev s kardioverter-defibrilatorjem (ICD)

Ta evropski standard podaja postopek za specifično ocenjevanje v skladu z dodatkom A standarda EN 50527 1:2015 za delavce z vsajenimi kardioverter-defibrilatorji. Ponuja različne pristope za izvedbo ocenjevanja tveganja, uporabiti pa je treba najprimernejšega. Če delavec dodatno uporablja druge aktivne medicinske vsadke (AIMD), mora biti ocenjen ločeno.

General Information

Status
Published
Public Enquiry End Date
20-Sep-2017
Publication Date
20-Aug-2018
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
27-Jul-2018
Due Date
01-Oct-2018
Completion Date
21-Aug-2018

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SLOVENSKI STANDARD
SIST EN 50527-2-2:2018
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
SIST EN 50527-2-2:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 50527-2-2:2018
---------------------- Page: 2 ----------------------
SIST EN 50527-2-2:2018
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
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SIST EN 50527-2-2:2018
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

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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (E)

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

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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (E)

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

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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (E)
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.
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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (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 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
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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (E)
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
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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (E)
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.

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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (E)

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 ?
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
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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (E)
Figure 2 — Specific assessment process
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SIST EN 50527-2-2:2018
EN 50527-2-2:2018 (E)
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 con
...

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