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

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
• Publication Date: 01-Dec-2016
• Withdrawal Date: 03-Jul-2019
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 17.240 - Radiation measurements
• Technical Committee: CLC/TC 106X - Electromagnetic fields in the human environment
• Drafting Committee: CLC/TC 106X/WG 15 - Emf and implants
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 02-Dec-2016
• Due Date: 18-Oct-2017
• Completion Date: 02-Dec-2016
• 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: 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

Relations

• Replaces: 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
• Revised: 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: 20-Aug-2014

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2017
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SIST EN 50527-2-1:2011
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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
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 zone
...