SIST EN 50527-2-1:2011
(Main)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
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 Annex A of EN 50527-1:2010 for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other AIMDs implanted additionally, they have to be assessed separately. The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace.
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
Postopek ocenjevanja izpostavljenosti delavcev z aktivnimi medicinskimi vsadki elektromagnetnim poljem - 2-1. del: Specifično ocenjevanje pri delavcih s srčnimi spodbujevalniki
Ta evropski standard določa postopek specifičnega ocenjevanja, zahtevanega v dodatku A in EN 50527-1:2010 za delavce z vsajenimi spodbujevalniki. Ponuja različne pristope za izvedbo ocene tveganja. Uporabiti se mora najprimernejši. Če ima delavec poleg tega vsajene druge aktivne medicinske pripomočke za vsaditev, morajo biti ocenjeni ločeno. Namen specifičnega ocenjevanja je določiti tveganja za delavce z vsajenimi spodbujevalniki, ki izhaja iz izpostavljenosti elektromagnentim poljem na delovnem mestu. Ocenjevanje vključuje verjetnost klinično pomembnih učinkov in upošteva prehodno in dolgotrajno izpostavljenost na nekaterih področjih delovnega mesta.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 50527-2-1:2011
01-julij-2011
3RVWRSHNRFHQMHYDQMDL]SRVWDYOMHQRVWLGHODYFHY]DNWLYQLPLPHGLFLQVNLPLYVDGNL
HOHNWURPDJQHWQLPSROMHPGHO 6SHFLILþQRRFHQMHYDQMHSULGHODYFLKVVUþQLPL
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 50527-2-1:2011
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
13.100 Varnost pri delu. Industrijska Occupational safety.
higiena Industrial hygiene
17.240 Merjenje sevanja Radiation measurements
SIST EN 50527-2-1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 50527-2-1:2011
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SIST EN 50527-2-1:2011
EUROPEAN STANDARD
EN 50527-2-1
NORME EUROPÉENNE
May 2011
EUROPÄISCHE NORM
ICS 11.040.40; 17.240
English version
Procedure for the assessment of the exposure to electromagnetic fields of
workers bearing active implantable medical devices -
Part 2-1: Specific assessment for workers with cardiac pacemakers
Procédure pour l’évaluation de l’exposition Verfahren zur Beurteilung der Exposition
des travailleurs porteurs de dispositifs von Arbeitnehmern mit aktiven
médicaux implantables actifs aux champs implantierbaren medizinischen Geräten
électromagnétiques - (AIMD) gegenüber elektromagnetischen
Partie 2-1: Spécification d’évaluation pour Feldern -
les travailleurs avec un simulateur Teil 2-1: Besondere Beurteilung für
cardiaque Arbeitnehmer mit Herzschrittmachern
This European Standard was approved by CENELEC on 2011-05-02. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 50527-2-1:2011 E
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SIST EN 50527-2-1:2011
EN 50527-2-1:2011 – 2 –
Foreword
This European Standard was prepared by the Technical Committee CENELEC TC 106X, Electromagnetic
fields in the human environment.
The text of the draft was submitted to the formal vote and was approved by CENELEC as EN 50527-2-1 on
2011-05-02.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement
(dop) 2012-05-02
– latest date by which the national standards conflicting
with the EN have to be withdrawn
(dow) 2014-05-02
This European Standard has been prepared under Mandate M/351 given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of EC Directive
2004/40/EC.
__________
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Contents
1 Scope . 5
2 References . 5
2.1 Normative references . 5
2.2 Regulatory references . 5
3 Terms and definitions . 6
4 Specific assessment . 7
4.1 Description of the assessment process . 7
4.2 Clinical investigation . 14
4.3 Non-clinical investigation . 14
5 Documentation . 19
Annex A (normative) Pacemaker specific replacement of EN 50527-1:2010, Table 1 . 20
Annex B (informative) Clinical investigation methods . 25
B.1 External ECG monitoring . 25
B.2 Assessment of pacemaker compatibility using stored data and diagnostic features . 25
B.3 Real time event monitoring by telemetry . 26
Annex C (informative) In vitro testing/measurements . 27
C.1 Introduction . 27
C.2 EM phantom . 27
C.3 Basic procedure for cardiac pacemaker in vitro testing . 28
C.4 References . 30
C.5 Literature . 30
Annex D (informative) Numerical modelling . 31
D.1 General . 31
D.2 Analytical techniques . 31
D.3 Numerical techniques . 31
D.4 Field modelling or calculations . 31
D.5 Modelling the human body and implant . 32
D.6 References . 32
Annex E (informative) Derived worst case conversions . 33
E.1 Introduction . 33
E.2 Functionality of implanted pacemaker leads . 33
E.3 Conversion based on known field strength. 34
E.4 Conversion based on known compliance with basic restrictions. 43
E.5 References . 47
Annex F (informative) Interference from power-frequency magnetic and electric fields from
transmission, distribution and use of electricity . 49
F.1 Sensitivity of pacemakers to interference . 49
F.2 Immunity requirements . 49
F.3 Voltage induced in the leads by magnetic fields . 50
F.4 Voltage induced in the leads by electric fields . 51
F.5 Values of 50 Hz magnetic and electric field that may cause interference . 54
F.6 Factors that affect the immunity from interference . 54
F.7 Application to exposure situations . 56
F.8 References . 58
Annex G (informative) Determination of the pacemaker immunity and guidelines provided by
pacemaker manufacturers – Determination method . 59
G.1 Introduction . 59
G.2 EMC and pacemakers – General guidelines . 59
G.3 Induced voltages, fields and zones . 62
G.4 References . 64
G.5 Literature . 64
Bibliography . 65
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EN 50527-2-1:2011 – 4 –
Figures
Figure 1 – Pacemaker specific assessment process 9
Figure 2 – Additional investigation process 12
Figure 3 – Comparison process 17
Figure C.1 – Example of in vitro procedure for EM interference at low frequency using plane electrodes and
ECG and data recording 29
Figure E.1 – Typical implantations of cardiac pacemakers (abdominal implantation with prolonged lead is
used in clinical environment only) 34
Figure E.2 – Effective induction area of an open wire loop inside a conductive medium 35
Figure E.3 – Schematic representation of bipolar pickup of interference in an infinitely extended
homogeneous conducting medium 36
Figure E.4 – Induced voltage on the implanted lead in a pure E field 38
Figure E.5 – Schematic graphs of the same voltage on the lead for different layouts 41
Figure E.6 – Eddy-current inside a conductive medium induced by varying magnetic flux 44
Figure E.7 – Voltage induced on a lead inside conductive body tissue 45
Figure E.8 – Voltages on an implanted lead 47
Figure F.1 – How the immunity ratio affects magnetic field that may result in interference 56
Figure F.2 – How the immunity ratio affects electric field that may result in interference 56
Figure G.1 – Induced voltage test levels 62
Figure G.2 – Magnetic field amplitudes, for frequencies below 5 000 kHz, producing test limits in unipolar
configurations 62
Figure G.3 – Induced voltage zones for unipolar configurations 63
Figure G.4 – Magnetic field zones, for frequencies below 5 000 kHz and for unipolar configurations 63
Tables
Table A.1 – Compliant workplaces and equipment with exceptions 20
Table F.1 – Amplitude of the immunity test signal applied 50
Table F.2 – Values of 50 Hz electric and magnetic field (r.m.s.) that might, under unfavourable
circumstances, cause interference in a pacemaker 54
Table F.3 – Summary of typical maximum field values beneath high-voltage overhead lines 57
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1 Scope
This European Standard provides the procedure for the specific assessment required in Annex A of
EN 50527-1:2010 for workers with implanted pacemakers. It offers different approaches for doing the risk
assessment. The most suitable one shall be used. If the worker has other AIMDs implanted additionally, they
have to be assessed separately.
The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers
arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of
clinically significant effects and takes account of both transient and long-term exposure within specific areas
of the workplace.
NOTE 1 This standard does not address risks to workers bearing a pacemaker from contact currents.
The techniques described in the different approaches may also be used for the assessment of publicly
accessible areas.
The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the
pacemaker occurs when the exposure limits are not exceeded.
NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in Clause 5 of ANSI/AAMI PC69:2007.
2 References
2.1 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN 50527-1:2010, Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices – Part 1: General
EN 45502-2-1:2003, Active implantable medical devices – Part 2-1: Particular requirements for active
implantable medical devices intended to treat bradyarrythmia (cardiac pacemakers)
EN 62226-3-1:2007, Exposure to electric or magnetic fields in the low and intermediate frequency range –
Methods for calculating the current density and internal electric field induced in the human body – Part 3-1:
Exposure to electric fields – Analytical and 2D numerical models (IEC 62226-3-1:2007)
2.2 Regulatory references
1999/519/EC: Council Recommendation of 12 July 1999 on the limitation of exposure of the general public to
electromagnetic fields (0 Hz to 300 GHz), Official Journal L 199, 30/07/1999, p. 59 – 70
2004/40/EC: Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004 on the
minimum health and safety requirements regarding the exposure of workers to the risks arising from physical
th
agents (electromagnetic fields) (18 individual Directive within the meaning of Article 16(1) of Directive
89/391/EEC), Official Journal L 159, 30/07/2004, p. 1–26
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EN 50527-2-1:2011 – 6 –
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 50527-1:2010 and the following
apply.
3.1
implantable pulse generator
IPG
part of the active implantable medical device, including the power supply and electronic circuit, that produces
an electrical output
NOTE For purposes of EN 50527-2-1, the term implantable pulse generator describes any active implantable medical device that
incorporates functions intended to treat cardiac arrhythmias.
3.2
pacemaker
active implantable medical device intended to treat bradyarrhythmias , comprising an implantable pulse
generator and lead(s)
NOTE CRT-P devices (Cardiac resynchronization therapy pacemaker) by their nature behave similar and are covered by this standard.
CRT-P devices are sometimes also called multi-channel pacemakers.
3.3
electrode
electrically conducting part (usually the termination of a lead) which is designed to form an interface with
body tissue or body fluid
3.4
unipolar lead
lead with one electrode
3.5
bipolar lead
lead with two electrodes that are electrically isolated from each other
3.6
reference levels
reference levels for general public exposure to electric, magnetic and electromagnetic fields as specified in
Council Recommendation 1999/519/EC
3.7
pacemaker-Employee
worker with an implanted pacemaker
NOTE For this worker, EN 50527-1 has revealed that a specific assessment following Annex A of EN 50527-1:2010 has to be done.
If this worker bears additionally other AIMD, they have to be assessed separately.
3.8
transient exposure
exposure to electromagnetic fields that is acceptable for pacemaker-Employee because it fulfils the following
requirements:
- the exposure is not constant: it comes to an end or reduces to non influential levels
- the exposure does not damage the pacemaker
- the exposure only leads to acceptable response of the pacemaker based on the advice from the
responsible physician (for example by general guidance or by a specific warning) and/or described in
the documentation accompanying the pacemaker
NOTE Such exposure may be caused by the electromagnetic field being temporary or by the exposed person moving within, or
through, an electromagnetic field. The duration of transient exposure varies widely and can only be determined as the result of the risk
assessment, based on the expected response of the pacemaker to the exposure and the physician’s advice on the acceptability of the
response
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3.9
assessment team
team consisting of
- employer and if applicable, his occupational health and safety experts and/or occupational physician,
- pacemaker-Employee and his responsible physician,
- (technical and medical) experts as necessary, e.g. manufacturer of the pacemaker
3.10
Holter monitor
Holter ECG monitor
device that continuously records the heart's rhythms
NOTE 1 The monitor is usually worn for 24 h – 48 h during normal activity.
NOTE 2 The above definition was adopted from NIH (U.S. National Institute of Health). The Holter monitor is named for
Dr. Norman J. Holter, who invented telemetric cardiac monitoring in 1949. Clinical use started in the early 1960s. Numerous medical
publications can be found referring to “Holter”, “Holter monitoring” or often also called “Holter ECG monitoring” (see e.g. PubMed at
http://www.ncbi.nlm.nih.gov/pubmed).
3.11
EM phantom
physical model containing tissue-equivalent material used to simulate the body in an experimental dose
measurement (from World Health Organisation)
NOTE EM phantoms are sometimes also referred to as torso simulator or phantom.
4 Specific assessment
4.1 Description of the assessment process
The risk assessment is based on the approach that, according to EN 45502-2-1, pacemakers are expected
to work uninfluenced as long as the General Public Reference levels of Council Recommendation
1999/519/EC are not exceeded (except for static magnetic fields and for pulsed high frequency
electromagnetic fields) (see also Clause F.7).
Further risk assessment is not necessary if a history of uninfluenced behaviour at the workplace exists and a
responsible physician has confirmed that this history is sufficient to exclude severe (clinically significant)
interaction.
A specific risk assessment for the pacemaker-Employee is required when there is history of influenced
behaviour or one of the following three conditions is fulfilled:
(a) there is equipment present in the workplace that is neither included in, nor used in accordance with
Table A.1;
(b) all equipment at the workplace is listed in Table A.1 (see Annex A) and is used accordingly, but the
pacemaker-Employee has received warning(s) from the responsible physician that the pacemaker may
be susceptible to electromagnetic interference (EMI), thereby increasing the risk at the workplace.
There are two types of warnings that may be given:
i. patient specific warnings provided by the responsible physician to the pacemaker-Employee due to
sensitivity settings in effect that may cause changes in pacemaker behaviour in the presence of
electromagnetic fields (EMF) that are below the reference levels; or
ii. general warnings supplied by the pacemaker manufacturer in accompanying documentation about
recognized behaviour changes of the pacemaker when it is subjected to EMF generated by specific
types of equipment;
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EN 50527-2-1:2011 – 8 –
(c) there is equipment present in the workplace that is neither included in, nor used in accordance with
Table A.1 and for which the pacemaker-Employee does have a history of uninfluenced behaviour while
in its presence, but the pacemaker-Employee has received a specific warning as described above.
In order to minimize the burden placed on the employer and pacemaker-Employee, the assessment should
begin with the investigation steps shown in Figure 1. The steps to be taken are based upon whether the
specific assessment is the result of an equipment issue or a patient warning issue.
When only condition (a) exists, then 4.1.1 shall apply. When only condition (b) exists, then 4.1.2 shall apply.
When condition (c) exists, then both 4.1.1 and 4.1.2 shall apply.
NOTE When a pacemaker is tested according to EN 45502-2-1, the manufacturer is required to provide a warning to the implanting
physician in the accompanying technical information as to any sensitivity settings available in the device that if used, afford the device
with a reduced immunity to certain types of EMI. A specific warning would only be given to the patient receiving the implant if they were
discharged with one of these settings in effect, or if at follow-up, a change to one of these settings was made for clinical reasons.
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Start
**Note:
Pacemaker Specific
See exception for situation of simultaneous
Assessment
equipment and patient warning
(Equipment
(Patient warning
consideration)
consideration)
Non-table 1 Equipment or
Y N
Table 1 use deviations?**
*Note:
Includes all field
Consult with
generating sources
Collect physician /
relevant data for employee:
equipment* Obtain warning
details
(Warning concerning settings)
Sufficient data exists
Is warning about
Y
N
to exclude significant
specific equipment?
interference?
Consult with
N Y
physician about
settings
Sufficient data exists
Is the equipment present
N Y
to restrict work?
in the workplace?
Y N
Can
warned settings be Y
N
avoided?
Change
settings
Work with possible restrictions Work allowed
(case 1) (case 2)
Document the results
Continue Inform employee about:
End
with Additional - Areas for continuous stay
Pacemaker Specific
Investigation - Areas of transient exposure
Assessment
(Fig. 2) - Areas of non-Access
Remind employee of guidelines given with the AIMD
Figure 1 – Pacemaker specific assessment process
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EN 50527-2-1:2011 – 10 –
4.1.1 Equipment consideration
Information relevant to the equipment or other field generating sources under consideration shall be
collected to answer sufficiently the following two questions:
• can it be determined that clinically significant interference with the pacemaker will not occur as a result of
expected exposure to the equipment under consideration? If so, no further assessment is required and
documentation of the result can proceed, as required in Clause 5;
• can it be determined that the pacemaker-Employee can return to the workplace only with restrictions
placed on the work tasks or areas of access? If so, no further assessment is required and documentation
of the work restrictions can proceed as required in Clause 5.
When neither of these questions can be answered positively, additional investigation, hereafter referred to as
“Case 1”, is required as specified in 4.1.3.
NOTE The intent of this clause is to find and utilize information that may already exist and that allows to conclude the assessment
without further, more costly and time consuming effort. It is recommended that experts who are likely to have such information be
contacted. Examples of such experts are the pacemaker manufacturer, equipment manufacturer, employer’s technical department,
consultants, or others skilled in EMI effects with implanted pacemakers.
4.1.2 Patient warning consideration
The responsible physician and pacemaker-Employee shall be consulted to determine the type of and details
for any EMI warnings applicable to the pacemaker.
If the warning is about behaviour of the pacemaker due to interference from particular types of equipment
(see 4.1 (b) (ii)) then it shall first be determined whether that equipment is actually present in the workplace:
• if the equipment is not present, the pacemaker-Employee is allowed to work without restrictions and the
pacemaker specific assessment can be concluded and documented as required in Clause 5.
• if the equipment subject to the warning is present, the steps given in 4.1.1 shall be taken.
If the warning is due to settings of the pacemaker in effect that may cause reduced immunity (see 4.1 (b) (i))
to EMI that is at or below the reference levels, the responsible physician shall be consulted to determine
whether the settings can be changed to avoid settings that are associated with the warning, thereby restoring
standard immunity levels:
• if it is determined that such a change of settings can be made, the pacemaker-Employee shall be advised
to arrange, through consultation with the responsible physician, for these changes of settings to be made
prior to returning to work. When the change of setting has been completed, the pacemaker-Employee is
allowed to work without restrictions. The results shall be documented as required in Clause 5 and the
assessment is concluded.
• if the settings cannot be changed, then additional investigation, hereafter referred to as “Case 2” is
required as discussed in 4.1.3.
4.1.3 Cases for additional investigation
When the investigation steps shown in Figure 1 have been followed but fail to mitigate or to dismiss risk to
the pacemaker-Employee from the effects of workplace EMI, then an additional investigation shall be
performed as shown in Figure 2 and described in 4.1.4. The goal of the investigation is to determine the
likelihood of a clinically significant response of the pacemaker to the EMI at the workplace that is the result of
the following.
• Case 1: Equipment is used at the workplace that is:
o neither listed in, nor used in accordance with, Table A.1, and for which there is no information
available that allows a pre-determination of safe or restricted work for the pacemaker-Employee, or
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o capable of emitting fields that may induce pacemaker lead voltages exceeding the immunity levels
established by conformity with the pacemaker product standard, EN 45502-2-1,
o known by the pacemaker manufacturer to potentially cause interference with the pacemaker and there
is no applicable safe use guideline available from other sources.
• Case 2: The responsible physician has prescribed settings of the pacemaker that make it susceptible to
EMI even from equipment listed in Table A.1.
If one of these cases is valid, an additional investigation as shown in Figure 2 and described in 4.1.4 shall be
per
...
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