EN 50527-2-1-2011 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、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 50527-2-1:2011Procedure for the assessmentof the exposure toelectromagnetic fields ofworkers bearing activeimplantable medical devices -Part 2-1: Specific assessment for wo

2、rkerswith cardiac pacemakersBS EN 50527-2-1:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN50527-2-1:2011.The UK participation in its preparation was entrusted to TechnicalCommittee GEL/106, Human exposure to low frequency and highfrequency electromagnetic

3、radiation.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 71590 7ICS 11.040.40; 13.280; 17

4、.240Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2011.Amendments issued since publicationDate Text affectedBS EN 50527-2-1:2011EUROPEAN STANDARD EN 5052

5、7-2-1 NORME EUROPENNE EUROPISCHE NORM May 2011 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2011 CENELEC - All rights of exploita

6、tion in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 50527-2-1:2011 E 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 2-1: Specific assessment fo

7、r workers with cardiac pacemakers Procdure pour lvaluation de lexposition des travailleurs porteurs de dispositifs mdicaux implantables actifs aux champs lectromagntiques - Partie 2-1: Spcification dvaluation pour les travailleurs avec un simulateur cardiaque Verfahren zur Beurteilung der Exposition

8、 von Arbeitnehmern mit aktiven implantierbaren medizinischen Gerten (AIMD) gegenber elektromagnetischen Feldern - Teil 2-1: Besondere Beurteilung fr Arbeitnehmer mit Herzschrittmachern This European Standard was approved by CENELEC on 2011-05-02. CENELEC members are bound to comply with the CEN/CENE

9、LEC 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 Central Secretariat or to any C

10、ENELEC 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 Central Secretariat has the same status as the official versio

11、ns. 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,

12、Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 50527-2-1:2011EN 50527-2-1:2011 2 Foreword This European Standard was prepared by the Technical Committee CENELEC TC 106X, Electromagnetic fields in the human environment. The text of the draft was submitted to the

13、 formal vote and was approved by CENELEC as EN 50527-2-1 on 2011-05-02. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-05-02 latest date by which the national standards

14、conflicting with the EN have to be withdrawn (dow) 2014-05-02 This European Standard has been prepared under Mandate M/351 given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 2004/40/EC. _ BS EN 50527-2-1:2011 3 EN 505

15、27-2-1:2011 Contents 1 Scope . 52 References 52.1 Normative references . 52.2 Regulatory references 53 Terms and definitions 64 Specific assessment 74.1 Description of the assessment process 74.2 Clinical investigation . 144.3 Non-clinical investigation 145 Documentation . 19Annex A (normative) Pace

16、maker specific replacement of EN 50527-1:2010, Table 1 . 20Annex B (informative) Clinical investigation methods 25B.1 External ECG monitoring 25B.2 Assessment of pacemaker compatibility using stored data and diagnostic features . 25B.3 Real time event monitoring by telemetry 26Annex C (informative)

17、In vitro testing/measurements . 27C.1 Introduction . 27C.2 EM phantom . 27C.3 Basic procedure for cardiac pacemaker in vitro testing 28C.4 References . 30C.5 Literature . 30Annex D (informative) Numerical modelling 31D.1 General . 31D.2 Analytical techniques 31D.3 Numerical techniques . 31D.4 Field

18、modelling or calculations . 31D.5 Modelling the human body and implant 32D.6 References . 32Annex E (informative) Derived worst case conversions . 33E.1 Introduction . 33E.2 Functionality of implanted pacemaker leads 33E.3 Conversion based on known field strength. 34E.4 Conversion based on known com

19、pliance with basic restrictions 43E.5 References . 47Annex F (informative) Interference from power-frequency magnetic and electric fields from transmission, distribution and use of electricity . 49F.1 Sensitivity of pacemakers to interference . 49F.2 Immunity requirements . 49F.3 Voltage induced in

20、the leads by magnetic fields 50F.4 Voltage induced in the leads by electric fields 51F.5 Values of 50 Hz magnetic and electric field that may cause interference 54F.6 Factors that affect the immunity from interference . 54F.7 Application to exposure situations 56F.8 References . 58Annex G (informati

21、ve) Determination of the pacemaker immunity and guidelines provided by pacemaker manufacturers Determination method . 59G.1 Introduction . 59G.2 EMC and pacemakers General guidelines 59G.3 Induced voltages, fields and zones 62G.4 References . 64G.5 Literature . 64Bibliography 65BS EN 50527-2-1:2011E

22、N 50527-2-1:2011 4 Figures Figure 1 Pacemaker specific assessment process 9Figure 2 Additional investigation process 12Figure 3 Comparison process 17Figure C.1 Example of in vitro procedure for EM interference at low frequency using plane electrodes and ECG and data recording 29Figure E.1 Typical im

23、plantations of cardiac pacemakers (abdominal implantation with prolonged lead is used in clinical environment only) 34Figure E.2 Effective induction area of an open wire loop inside a conductive medium 35Figure E.3 Schematic representation of bipolar pickup of interference in an infinitely extended

24、homogeneous conducting medium 36Figure E.4 Induced voltage on the implanted lead in a pure E field 38Figure E.5 Schematic graphs of the same voltage on the lead for different layouts 41Figure E.6 Eddy-current inside a conductive medium induced by varying magnetic flux 44Figure E.7 Voltage induced on

25、 a lead inside conductive body tissue 45Figure E.8 Voltages on an implanted lead 47Figure F.1 How the immunity ratio affects magnetic field that may result in interference 56Figure F.2 How the immunity ratio affects electric field that may result in interference 56Figure G.1 Induced voltage test lev

26、els 62Figure G.2 Magnetic field amplitudes, for frequencies below 5 000 kHz, producing test limits in unipolar configurations 62Figure G.3 Induced voltage zones for unipolar configurations 63Figure G.4 Magnetic field zones, for frequencies below 5 000 kHz and for unipolar configurations 63Tables Tab

27、le A.1 Compliant workplaces and equipment with exceptions 20Table F.1 Amplitude of the immunity test signal applied 50Table F.2 Values of 50 Hz electric and magnetic field (r.m.s.) that might, under unfavourable circumstances, cause interference in a pacemaker 54Table F.3 Summary of typical maximum

28、field values beneath high-voltage overhead lines 57BS EN 50527-2-1:2011 5 EN 50527-2-1:2011 1 Scope This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527-1:2010 for workers with implanted pacemakers. It offers different approaches for doing the ris

29、k assessment. The most suitable one shall be used. If the worker has other AIMDs implanted additionally, they have 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 w

30、orkplace. 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 to workers bearing a pacemaker from contact currents. The techniques descr

31、ibed 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 observat

32、ion range to 3 GHz can be found in Clause 5 of ANSI/AAMI PC69:2007. 2 References 2.1 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the

33、 referenced document (including any amendments) applies. EN 50527-1:2010, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 1: General EN 45502-2-1:2003, Active implantable medical devices Part 2-1: Particular requiremen

34、ts for active implantable medical devices intended to treat bradyarrythmia (cardiac pacemakers) EN 62226-3-1:2007, Exposure to electric or magnetic fields in the low and intermediate frequency range Methods for calculating the current density and internal electric field induced in the human body Par

35、t 3-1: Exposure to electric fields Analytical and 2D numerical models (IEC 62226-3-1:2007) 2.2 Regulatory references 1999/519/EC: Council Recommendation of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz), Official Journal L 199, 30/07/1999

36、, p. 59 70 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) (18thindividual Directive within the meaning o

37、f Article 16(1) of Directive 89/391/EEC), Official Journal L 159, 30/07/2004, p. 126 BS EN 50527-2-1:2011EN 50527-2-1:2011 6 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 50527-1:2010 and the following apply. 3.1 implantable pulse generator IPG part

38、 of the active implantable medical device, including the power supply and electronic circuit, that produces an electrical output NOTE For purposes of EN 50527-2-1, the term implantable pulse generator describes any active implantable medical device that incorporates functions intended to treat cardi

39、ac arrhythmias. 3.2 pacemaker active implantable medical device intended to treat bradyarrhythmias , comprising an implantable pulse generator and lead(s) NOTE CRT-P devices (Cardiac resynchronization therapy pacemaker) by their nature behave similar and are covered by this standard. CRT-P devices a

40、re sometimes also called multi-channel pacemakers. 3.3 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 electri

41、cally isolated from each other 3.6 reference levels reference levels for general public exposure to electric, magnetic and electromagnetic fields as specified in Council Recommendation 1999/519/EC 3.7 pacemaker-Employee worker with an implanted pacemaker NOTE For this worker, EN 50527-1 has revealed

42、 that a specific assessment following Annex A of EN 50527-1:2010 has to be done. If this worker bears additionally other AIMD, they have to be assessed separately. 3.8 transient exposure exposure to electromagnetic fields that is acceptable for pacemaker-Employee because it fulfils the following req

43、uirements: - the exposure is not constant: it comes to an end or reduces to non influential levels - the exposure does not damage the pacemaker - the exposure only leads to acceptable response of the pacemaker based on the advice from the responsible physician (for example by general guidance or by

44、a specific warning) and/or described in the documentation accompanying the pacemaker NOTE Such exposure may be caused by the electromagnetic field being temporary or by the exposed person moving within, or through, an electromagnetic field. The duration of transient exposure varies widely and can on

45、ly be determined as the result of the risk assessment, based on the expected response of the pacemaker to the exposure and the physicians advice on the acceptability of the response BS EN 50527-2-1:2011 7 EN 50527-2-1:2011 3.9 assessment team team consisting of - employer and if applicable, his occu

46、pational 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 3.10 Holter monitor Holter ECG monitor device that continuously records the hearts rhythms NOTE 1 T

47、he monitor is usually worn for 24 h 48 h during normal activity. NOTE 2 The above definition was adopted from NIH (U.S. National Institute of Health). The Holter monitor is named for Dr. Norman J. Holter, who invented telemetric cardiac monitoring in 1949. Clinical use started in the early 1960s. Nu

48、merous medical publications can be found referring to “Holter”, “Holter monitoring” or often also called “Holter ECG monitoring” (see e.g. PubMed at http:/www.ncbi.nlm.nih.gov/pubmed). 3.11 EM phantom physical model containing tissue-equivalent material used to simulate the body in an experimental dose measurement (from World Health Organisation) NOTE EM phantoms are sometimes also referred to as torso simulator or phantom. 4 Specific assessment 4.1 Description of the assessment process The risk assessment is based on the approach that, accord