EN 50527-2-2-2018 en Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2 Specific assessment for.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devicesPart 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)BS EN 5052722:

2、2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50527-2-2 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

3、 defibrillators (ICDs) Procdure pour lvaluation de lexposition des travailleurs porteurs de dispositifs mdicaux implantables actifs aux champs lectromagntiques - Partie 2-2 : Evaluation spcifique aux travailleurs porteurs de dfibrillateurs automatiques implantables Verfahren zur Beurteilung der Expo

4、sition von Arbeitnehmern mit aktiven implantierbaren medizinischen Gerten gegenber elektromagnetischen Feldern - Teil 2-2: Besondere Beurteilung fr Arbeitnehmer mit Cardioverter-Defibrillatoren (ICDs) This European Standard was approved by CENELEC on 2018-04-03. CENELEC members are bound to comply w

5、ith 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 Man

6、agement 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 th

7、e 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

8、, 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 Comit Europen de Normalisation Electrotechnique Europisches Komitee fr El

9、ektrotechnische 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 National forewordThis British Standard is the UK implementation of EN

10、 5052722:2018.The UK participation in its preparation was entrusted to Technical Committee GEL/106, Human exposure to low frequency 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

11、 purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 98384 9ICS 17.240; 11.040.40Compliance with a British Standard cannot confer immunity from l

12、egal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 5052722:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50527-2-2 May

13、 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) Procdure pour lvaluation de lexposition des tra

14、vailleurs porteurs de dispositifs mdicaux implantables actifs aux champs lectromagntiques - Partie 2-2 : Evaluation spcifique aux travailleurs porteurs de dfibrillateurs automatiques implantables Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Ger

15、ten gegenber elektromagnetischen Feldern - Teil 2-2: Besondere Beurteilung fr Arbeitnehmer mit Cardioverter-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 condition

16、s 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

17、 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 nation

18、al 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, Portu

19、gal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Rue de la Scien

20、ce 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 BS EN 5052722:2018EN 50527-2-2:2018 (E) 2 Contents Page European foreword 5 1 Scope . 6 2 Normative references . 6 3 Terms and definitions

21、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 invest

22、igation 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

23、 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

24、 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 .

25、 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 fie

26、lds 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 Applica

27、tion 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 BS EN 5052722:2018EN 505

28、27-2-2:2018 (E) 3 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 anal

29、yse 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

30、.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

31、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 Speci

32、fic 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

33、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 resu

34、lt 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 interference 41 Figure E.7 Showing how the tip to ring spacing affects the electric

35、 field that can result in interference 42 Figure E.8 Eddy-current inside a conductive medium induced by varying magnetic flux . 45 Figure E.9 Voltage induced on a lead inside conductive body tissue 46 Figure E.10 Voltages on an implanted lead 47 Figure G.1 Induced voltage test levels . 55 Figure G.2

36、 Magnetic field amplitudes, for frequencies below 10 000 kHz, producing test limits in bipolar configurations . 56 Figure G.3 Induced voltage zones for bipolar configurations 57 Figure G.4 Induced voltage zones for bipolar configurations 58 BS EN 5052722:2018EN 50527-2-2:2018 (E) 4 Figure G.5 Magnet

37、ic field zones, for frequencies below 10 000 kHz for bipolar configurations 59 Tables Table A.1 Compliant workplaces and equipment with exceptions . 21 Table E.1 Values of 50 Hz electric and magnetic field (r.m.s.) that might, under unfavourable circumstances, cause interference with devices 38 Tabl

38、e E.2 Summary of typical maximum field values beneath high-voltage overhead lines and corresponding voltage induced in the device . 43 Table E.3 a) Voltage induced in bipolar leads by the health effects ELV where f is in Hz . 44 Table E.3 b) Voltage induced in bipolar leads by the sensory effects EL

39、V, where f is in Hz. It is defined only up to 400 Hz . 44 BS EN 5052722:2018EN 50527-2-2:2018 (E) 5 European foreword This document (EN 50527-2-2:2018) has been prepared by CLC/TC 106X “Electromagnetic fields in the human environment”. The following dates are fixed: latest date by which this documen

40、t has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2019-04-03 latest date by which the national standards conflicting with this document have to be withdrawn (dow) 2021-04-03 Attention is drawn to the possibility that some of the elemen

41、ts of this document may be the subject of patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association. BS EN 5052722:2018EN 5052

42、7-2-2:2018 (E) 6 1 Scope This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy devices with associated defibrillation functions (CRT-D). Only

43、devices of this type equipped with leads implanted transvenously are considered. It offers different approaches for doing the risk assessment. NOTE 1 If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they are assessed separately according to EN 505271 or othe

44、r particular standards within the EN 50527 series. NOTE 2 The risks to patients due to interference with pacing functions associated with CRT-D devices are assessed using EN 505272-1. The purpose of the specific assessment is to determine the risk for workers with implanted ICDs and CRT-Ds arising f

45、rom exposure to electromagnetic fields (EMF) 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 3 This standard does not address risks from contact currents

46、. 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 devices within the scope of this Particular Standard is expected to occur when the e

47、xposure limits are not exceeded. NOTE 4 The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5. NOTE 5 Further information concerning the functions of Pacemakers, CRT-D, and ICD devices can be found in Ellenbogen and Kaszala, 2014. 2 Normative references T

48、he following documents, in 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

49、-2-2:2008, Active implantable medical devices Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) EN 50527-1:2016, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 1: General EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice (ISO 14155) ISO 14117: