EN 50527-2-3:2021
(Main)Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators
This document provides the procedure for the specific assessment required in EN 50527 1:2016, Annex A, for workers with implanted neurostimulator systems (NS), specifically of the type used for spinal cord stimulation (SCS). It is recognized that implantable neurostimulators have been developed for a wide variety of clinical applications, however the SCS devices within the scope of this document represent the largest segment of the implantable neurostimulator applications thus far. 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. The purpose of the specific assessment is to determine the risk for workers with implanted SCS devices arising from exposure to electromagnetic fields (EMF) at the workplace. The assessment includes the likelihood of clinically significant effects. NOTE 2 This document does not address risks from contact currents, or the effects upon any associated non-implantable devices (e.g. Patient Programmers). The techniques described in the different approaches can 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 document is expected to occur. NOTE 3 The rationale for limiting the observation range to 3 GHz can be found in ISO 14708 3 [1]. NOTE 4 Further information concerning the functions of neurostimulator systems can be found at https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Cord-Stimulation.
Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Geräten gegenüber elektromagnetischen Feldern - Teil 2-3: Besondere Beurteilung für Arbeitnehmer mit implantierbaren Neurostimulatoren
Procédure pour l'évaluation de l'exposition des travailleurs porteurs de dispositifs médicaux implantables actifs aux champs électromagnétiques - Partie 2-3 : Evaluation spécifique aux travailleurs porteurs de neurostimulateurs implantés
Le présent document fournit la procédure d’évaluation spécifique exigée dans l’Annexe A de l’EN 50527 1:2016, pour les travailleurs porteurs de systèmes neurostimulateurs (SN) implantés, spécifiquement du type utilisé pour la stimulation médullaire (SM). Il est admis que des neurostimulateurs implantables ont été développés pour un grand nombre d’applications cliniques; toutefois, les dispositifs de SM qui relèvent du domaine d’application du présent document représentent jusqu’à présent le plus grand segment des applications de neurostimulateurs implantables. NOTE 1 Si le travailleur porte, en plus, d’autres dispositifs médicaux implantables actifs (DMIA) implantés, ceux-ci sont évalués de manière individuelle conformément à l’EN 50527 1 ou à d’autres normes particulières de la série EN 50527. Cette évaluation spécifique a pour objet de déterminer, pour des travailleurs porteurs de dispositifs de SM implantés, le risque qui provient de l’exposition aux champs électromagnétiques (EMF – electromagnetic fields) sur le lieu de travail. L’évaluation comprend la probabilité d’effets cliniquement significatifs. NOTE 2 Le présent document ne traite pas des risques vis-à-vis des courants de contact ni des effets sur tout dispositif non implantable associé (par exemple, un dispositif de programmation du patient). 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 le spectre entre 0 Hz et 3 GHz. Au-dessus de 3 GHz, aucune interférence n’est réputée se produire avec les dispositifs qui relèvent du domaine d’application du présent document. NOTE 3 La justification de la limitation de la plage d’observation à 3 GHz peut être consultée dans l’ISO 14708 3 [1]. NOTE 4 Des informations complémentaires relatives aux fonctions des systèmes neurostimulateurs peuvent être consultées à l’adresse https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Cord-Stimulation.
Postopek ocenjevanja izpostavljenosti delavcev z aktivnimi medicinskimi vsadki elektromagnetnim poljem - 2-3. del: Specifično ocenjevanje delavcev z vsadljivimi nevrostimulatorji
Ta evropski standard podaja postopek specifičnega ocenjevanja v skladu z dodatkom A standarda EN 50527 1:2015 za delavce z vsajenimi nevrostimulatorji (npr. v hrbtenjači, globoko v možganih, v mrežnici in mehurju). 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
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2022
Postopek ocenjevanja izpostavljenosti delavcev z aktivnimi medicinskimi vsadki
elektromagnetnim poljem - 2-3. del: Specifično ocenjevanje delavcev z vsadljivimi
nevrostimulatorji
Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices - Part 2-3: Specific assessment for workers
with implantable neurostimulators
Ta slovenski standard je istoveten z: EN 50527-2-3:2021
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 50527-2-3
NORME EUROPÉENNE
EUROPÄISCHE NORM October 2021
ICS 17.240; 11.040.40
English Version
Procedure for the assessment of the exposure to
electromagnetic fields of workers bearing active implantable
medical devices - Part 2-3: Specific assessment for workers with
implantable neurostimulators
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 2-3 : Evaluation Geräten gegenüber elektromagnetischen Feldern - Teil 2-3:
spécifique aux travailleurs porteurs de neurostimulateurs Besondere Beurteilung für Arbeitnehmer mit
implantés implantierbaren Neurostimulatoren
This European Standard was approved by CENELEC on 2021-08-09. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, 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
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 50527-2-3:2021 E
Contents Page
European foreword . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Specific assessment . 9
4.1 Overview of specific assessments . 9
4.1.1 Relation to OH&S Management Systems. 9
4.1.2 Description of the assessment process . 9
4.2 Specific assessment phase 0: Exclusion based on history and physician warnings . 12
4.3 Specific assessment phase 1: Consideration of equipment and SCS therapy type . 13
4.4 Specific assessment phase 2a – workplace EMF compared to Action Levels . 15
4.5 Overview of specific assessment phases 2b and 2c . 17
4.6 Methodology for assessment of unintended nerve stimulation and tissue damage risk . 18
4.6.1 General . 18
4.6.2 Overview of the assessment method given in Annexes D and E . 18
4.6.3 Selection of device parameters for assessment . 19
4.6.4 Assessment levels for electric and magnetic fields . 19
4.6.5 NSR and TDR calculation results for unipolar and bipolar configurations . 23
4.6.6 Phase 2a risk assessment summary . 26
4.7 Specific Assessment phase 2b – workplace EMF compared to NSR / TDR EMF threshold
levels 27
4.7.1 Phase 2b general approach . 27
4.7.2 EMF threshold zones . 27
4.7.3 Conversion of EMF values . 29
4.7.4 Phase 2b assessment procedure . 29
4.8 Specific assessment phase 2c – adjustments for known lead characteristics . 39
4.8.1 Phase 2c general approach . 39
4.8.2 Phase 2c assessment procedure . 41
5 Documentation . 42
Annex A (normative) Device specific replacement of EN 50527-1:2016, Table 1 . 43
Annex B (informative) Rationale . 47
B.1 Introduction . 47
B.2 Rationale for specific clauses of this document . 47
Annex C (informative) Nerve Stimulation for SCS . 48
C.1 Neurostimulation techniques . 48
C.2 Spinal Cord Stimulation . 48
Annex D (informative) Selection of Conductivity Values for SCS Modelling . 54
D.1 The use of conductivity in the standard . 54
D.2 Conductivity literature . 54
D.3 Selection of values for tissue Types . 59
D.4 Summary . 65
Annex E (informative) Modelling Nerve Stimulation for SCS. 66
E.1 Introduction . 66
E.2 Internal electric field threshold for nerve stimulation . 80
E.3 Avoiding damage to tissue . 82
E.4 Assessment of voltages and currents induced in leads . 86
E.5 Assessment of nerve stimulation from external fields . 93
E.6 Assessment of tissue damage from external fields . 97
E.7 Overall assessment . 100
Annex F (informative) Electrode factor for non-isotropic tissue . 101
F.1 Application to isotropic tissue . 101
F.2 Application to non-isotropic tissue . 103
Bibliography . 105
Figures
Figure 1 — Overview of the assessment process . 11
Figure 2 — Summary of assessment exclusion criteria . 12
Figure 3 — Specific assessment phase 1 . 14
Figure 4 — Specific assessment phase 2a — Initial assessment of risk of unintended nerve stimulation or
tissue damage . 17
Figure 5 — Magnetic field assessment levels as selected (also Figure E.14) . 21
Figure 6 — Electric field assessment levels as selected (also Figure E.16) . 22
Figure 7 — Values of NSR for assessed electric field exposures . 23
Figure 8 — Values of TDR for assessed electric field exposures . 24
Figure 9 — Values of NSR for assessed magnetic field exposures . 25
Figure 10 — Values of TDR for assessed magnetic field exposures . 26
Figure 11 — Maximum E-field for cylindrical-type bipolar lead stimulation . 31
Figure 12 — Maximum E-field for paddle-type bipolar lead stimulation . 32
Figure 13 — Maximum B-field for bipolar single lead stimulation . 33
Figure 14 — Maximum B-field for bipolar two lead stimulation . 34
Figure 15 — Maximum E-field for unipolar lead stimulation . 35
Figure 16 — Maximum E-field for unipolar lead stimulation (1 MHz to 100 MHz) . 36
Figure 17 — Maximum B-field for unipolar lead stimulation . 37
Figure 18 — Maximum B-field for unipolar lead stimulation (100 MHz to 5 GHz). 38
Figure 19 — Specific assessment phase 2c —Re-assessment of tissue damage risk using known lead
characteristics . 40
Figure C.1 — Typical implantations of spinal cord stimulation devices . 49
Figure C.2 — Leads and electrodes for spinal cord stimulation — Paddle leads have flat electrodes and
percutaneous leads have cylindrical electrodes . 50
Figure C.3 — Cross section of spine showing the different regions . 52
Figure D.1 — Conductivity values from 1996 modelled data . 55
Figure D.2 — Conductivities for cerebrospinal tissues (2007 data) . 57
Figure D.3 — Conductivities for cerebrospinal tissues (1996 and 2009 data) . 58
Figure D.4 — Conductivity for fat (not infiltrated, average infiltrated, fully infiltrated) . 60
Figure D.5 — Cross section of spine showing the different regions . 62
Figure D.6 — Layers of tissue adjacent to spinal cord . 63
Figure D.7 — Variation of directional conductivities and their ratio with frequency and the anisotropy factor 64
Figure D.8 — Values of frequency dependent parameters related to conductivity as used in Annex E . 65
Figure E.1 — Simplified linear circuit model for isolated patch of excitable membrane. Fro
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