EN 50527-2-1-2016 en Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1 Specific assessment for.pdf

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1、BS EN 50527-2-1:2016Procedure for the assessmentof the exposure toelectromagnetic fields ofworkers bearing activeimplantable medical devicesPart 2-1: Specific assessment for workerswith cardiac pacemakersBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 50527-2-1

2、:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 50527-2-1:2016. It supersedes BS EN 50527-2-1:2011 which will be withdrawn on 4 July 2019.The UK participation in its preparation was entrusted to Technical Committee GEL/106, Human exposure to low frequency

3、and high frequency electromagnetic radiation.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Stand

4、ards Institution 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 89771 9 ICS 11.040.40; 13.280; 17.240 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee o

5、n 31 January 2017.Amendments/corrigenda issued since publicationDate Text affectedBS EN 50527-2-1:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50527-2-1 December 2016 ICS 11.040.40; 17.240 Supersedes EN 50527-2-1:2011 English Version Procedure for the assessment of the exposure to electr

6、omagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers Procdure pour lvaluation de lexposition des travailleurs porteurs de dispositifs mdicaux implantables actifs aux champs lectromagntiques - Partie 2-1: Spcificati

7、on dvaluation pour les travailleurs avec un simulateur cardiaque Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Gerten (AIMD) gegenber elektromagnetischen Feldern - Teil 2-1: Besondere Beurteilung fr Arbeitnehmer mit Herzschrittmachern This Europ

8、ean 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

9、 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 CENE

10、LEC 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

11、 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 Standard

12、ization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr 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

13、:2016 E BS EN 50527-2-1:2016EN 50527-2-1:2016 (E) 2 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 consider

14、ation 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 Documen

15、tation . 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 monitori

16、ng 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 .

17、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 Fu

18、nctionality 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 k

19、Hz) . 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 BS EN 50527-2-1:2016 EN 50527-2-1:2016 (E) 3 E.3.8 High frequency range (above 30 MHz) 44 E.4 Conversion based on known compliance with basic restr

20、ictions 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 densit

21、y 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 I

22、mmunity 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 improve

23、d 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

24、) 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 pro

25、ducing test limits . 65 G.3.3 Induced voltage zones . 67 G.3.4 Magnetic field zones 67 G.4 References . 68 G.5 Literature . 69 Bibliography . 70 Figures Figure 1 Overview of the assessment process . 9 Figure 2 Pacemaker specific assessment process 10 Figure 3 Additional investigation process 13 Figu

26、re 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 31 Figure E.1 Typical implantations of cardiac pacemakers (abdominal implantation with prolonged lead is used in clinical environm

27、ent only) . 36 Figure E.2 Effective induction area of an open wire loop inside a conductive medium 37 Figure E.3 Schematic representation of bipolar pickup of interference in an infinitely extended homogeneous conducting medium 39 Figure E.4 Induced voltage on the implanted lead in a pure E field .

28、41 Figure E.5 Schematic graphs of the same voltage on the lead for different layouts 43 Figure E.6 Eddy-current inside a conductive medium induced by varying magnetic flux 47 BS EN 50527-2-1:2016EN 50527-2-1:2016 (E) 4 Figure E.7 Voltage induced on a lead inside conductive body tissue . 48 Figure E.

29、8 Voltages on an implanted lead . 50 Figure F.1 How the immunity ratio affects magnetic field that may result in interference 58 Figure F.2 How the immunity ratio affects electric field that may result in interference . 59 Figure G.1 Induced voltage test levels 65 Figure G.2 Magnetic field amplitude

30、s, for frequencies below 5 000 kHz, producing test limits in unipolar configurations 66 Figure G.3 Induced voltage zones for unipolar configurations 67 Figure G.4 Magnetic field zones, for frequencies below 5 000 kHz and for unipolar configurations . 68 Tables Table A.1 Compliant workplaces and equi

31、pment with exceptions . 21 Table F.1 Amplitude of the immunity test signal applied 53 Table F.2 Values of 50 Hz electric and magnetic field (r.m.s.) that might, under unfavourable circumstances, cause interference in a pacemaker 56 Table F.3 Summary of typical maximum field values beneath high-volta

32、ge overhead lines at 1 m above ground . 60 BS EN 50527-2-1:2016 EN 50527-2-1:2016 (E) 5 European foreword This document (EN 50527-2-1:2016) 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

33、implementedat national level by publication of an identical nationalstandard or by endorsement(dop) 2017-07-04 latest date by which the national standards conflicting withthis document have to be withdrawn(dow) 2019-07-04 This document supersedes EN 50527-2-1:2011. This document has been prepared un

34、der a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). EN 50527 is currently composed with the following parts: EN 50527-1, Procedure for the assessment of the exposure to electromagnetic fields of wo

35、rkers bearing active implantable medical devices Part 1: General; EN 50527-2-1, 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; prEN 50527-2-2, Procedure fo

36、r the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 2-2: Specific assessment for workers with implantable cardioverter defibrillators1). 1) Currently at drafting stage.BS EN 50527-2-1:2016EN 50527-2-1:2016 (E) 6 1 Scope This European

37、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

38、) 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 effe

39、cts 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 frequen

40、cy 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. 2 Normative references The following documents, i

41、n 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 45502-2-1:20032), Active impla

42、ntable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) EN 50413, Basic standard on measurement and calculation procedures for human exposure to electric, magnetic and electromagnetic fields (0 Hz - 300 GH

43、z) EN 50527-1:2016, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 1: General 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

44、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 EN 5052721, the term implantable pulse generator describes any active implantable medical device t

45、hat incorporates functions intended to treat cardiac arrhythmias. 3.2 pacemaker active implantable medical device intended to treat bradyarrhythmias, comprising an implantable pulse generator with or without lead(s) 2) The EMC requirements within EN 455022-1 have been incorporated with updates into

46、ISO 14117 and their use is recommendedhere.BS EN 50527-2-1:2016 EN 50527-2-1:2016 (E) 7 Note 1 to entry: 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

47、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 pacemaker-employee w

48、orker with an implanted pacemaker Note 1 to entry: For this worker, EN 505271 has revealed that a specific assessment following EN 505271:2016, Annex A needs to be done. If this worker bears additionally other AIMD, they need to be assessed separately. 3.7 assessment team team consisting of: employe

49、r 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 3.8 Holter monitor Holter ECG monitor device that continuously records the hearts rhythms Note 1 to entry: The monitor is usually worn for 24 h 48 h during normal activity. Note 2 to entry: The above definition was adopted from NIH (US. National