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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
i
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