BS EN 50527-1-2010 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - General《工作轴承有源植入性医疗器械的电磁场辐射暴露的评定规程.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationProcedure for the assessment of the exposure to electromagnetic fields of workers bearing activeimplantable medical devicesPart 1: GeneralBS EN 50527-1:2010National forewordThis

2、British Standard is the UK implementation of EN 50527-1:2010.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 onrequ

3、est to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2010ISBN 978 0 580 64934 9ICS 11.040.40; 13.100; 13.280Compliance with a British Standard cannot confer immunity fromlegal obligations.T

4、his British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 May 2010.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 50527-1:2010EUROPEAN STANDARD EN 50527-1 NORME EUROPENNE EUROPISCHE NORM April 2010 CENELEC European

5、 Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELE

6、C members. Ref. No. EN 50527-1:2010 E ICS 11.040.40; 13.100; 13.280 English version Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General Procdure pour lvaluation de lexposition des travailleurs porteurs de disp

7、ositifs mdicaux implantables actifs aux champs lectromagntiques - Partie 1 : Gnralits Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Gerten (AIMD) gegenber elektromagnetischen Feldern - Teil 1: Allgemeine Festlegungen This European Standard was a

8、pproved by CENELEC on 2010-02-01. 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 n

9、ational standards may be obtained on application to the Central Secretariat 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 lang

10、uage and notified to the Central Secretariat 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, I

11、taly, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 50527-1:2010EN 50527-1:2010 2 Foreword This European Standard was prepared by the Technical Committee CENELEC TC 106X, Electrom

12、agnetic fields in the human environment. The text of the draft was submitted to the formal vote and was approved by CENELEC as EN 50527-1 on 2010-02-01. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be

13、held responsible for identifying any or all such patent rights. 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) 2011-02-01 latest date by which the national standards conflict

14、ing with the EN have to be withdrawn (dow) 2013-02-01 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. The human exposure to electromagnetic f

15、ields (EMF) is regulated at European level in a twofold way. For the general public, Council Recommendation 1999/519/EC stipulates maximum exposure limits based on the ICNIRP guidelines. Nevertheless, Article 153 of the European treaty grants the member states the right to set stricter limit values

16、in their obligation to govern public health and safety. For occupational exposure directive (2004/40/EC) as individual physical agents directive issued under the occupational health and safety framework directive 89/391/EEC sets the minimum health and safety requirements based on the maximum occupat

17、ional exposure limits of the ICNIRP guidelines. Common to both directives limiting human exposure to EMF and to the ICNIRP guidelines is the fact that their limit values are based on direct effects of EMF exposure to the human body. For the low frequency range the induced current density in the nerv

18、ous system is the limiting factor whereas in the higher frequency area tissue heating by absorption has to be limited. The occupational exposure directive 2004/40/EC in Article 4.5 additionally obliges the employer to investigate during the risk assessment process also indirect effects like interfer

19、ence with medical electronic equipment and devices (including cardiac pacemakers and other implanted devices). Risks to the bearer may be caused by different effects: a conductive implant may directly cause an increase of current density in the body tissue surrounding the implant, or the behaviour o

20、f the device may be interfered with (for examples see D.8). The possibility of interference to the device depends on the EMF exposure level and the electromagnetic performance of the device, its settings and the method of implantation. The clinical relevance of interference may depend on the duratio

21、n of exposure. The main objective of this standard is to describe how a risk assessment for an employee bearing one or more active implantable medical devices (AIMD-Employee) in electromagnetic fields may be performed. A first step consists of a simplified risk analysis, followed where necessary, by

22、 a more extensive risk assessment. BS EN 50527-1:2010 3 EN 50527-1:2010 Directives 90/385/EEC and 2007/47/EC on medical devices requires that AIMDs are designed and manufactured in such a way as to remove or minimize as far as possible risks connected with reasonably foreseeable environmental condit

23、ions such as magnetic fields, external electromagnetic interference effects, and electrostatic discharge. EN 50499 introduces a concept of identifying equipment not likely to cause exposure to EMF above the limit values. This standard follows this approach but some of the identified equipment for ge

24、neral purpose assessment may need further analysis for AIMD-Employee. For higher frequency exposures, human body tissue has a time constant with respect to heating effects and a high immunity to pulsating exposure, whereas the electronic circuitry of an implant may be interfered with even by short p

25、ulses. _ BS EN 50527-1:2010EN 50527-1:2010 4 Contents 1 Scope . 6 2 Relationship to other standards . 6 3 References 7 3.1 Normative references . 7 3.2 Regulatory references 7 4 Terms and definitions 8 5 Risk assessment 9 5.1 Risk assessment procedure . 9 5.2 Documentation and information for the AI

26、MD-Employee 13 5.3 Maintaining the risk assessment 13 6 Equipment at workplaces 13 7 Special cases 18 8 AIMD-Employees with more than one AIMD 18 9 Documentation . 18 Annex A (normative) Specific risk assessment . 19 A.1 General 19 A.2 Non-clinical approach. 19 A.3 Clinical approach 20 A.4 Documenta

27、tion of the specific assessment. 20 Annex B (informative) Documenting the risk assessment . 22 B.1 Introduction 22 B.2 Workplace compliance documentation form 22 B.3 Previously uninfluenced behaviour 24 B.4 Documenting the detailed risk assessment . 25 Annex C (informative) Specific electromagnetic

28、environments. 28 C.1 Railways . 28 C.2 Workplace power transmission and distribution 28 C.3 Broadcasting 30 Annex D (informative) Theoretical considerations 31 D.1 Introduction 31 D.2 Brief summary of exposure limits for persons without implant 31 D.3 General considerations about electromagnetic fie

29、lds 34 D.4 General considerations about AIMDs 35 D.5 Description of electromagnetic interference effects . 36 D.6 Model to assess the possibility of induction of AIMD response . 36 D.7 Possibility of induced AIMD response 37 D.8 Clinical relevance of AIMD response . 38 Bibliography . 39 BS EN 50527-

30、1:2010 5 EN 50527-1:2010 Figures Figure 1 Relationship of standards . 7 Figure 2 Risk assessment process 12 Figure D.1 Reference levels for whole body exposure according to 1999/519/EC 33 Figure D.2 Field strength Distance ratio 34 Figure D.3 Near field far field transition for sources smaller than

31、half wavelength in size 34 Figure D.4 Entire model to assess the possibility of induction of AIMD response . 36 Figure D.5 Simplified model to assess the possibility of AIMD response in special cases 37 Tables Table 1 Compliant workplaces and equipment with exceptions. 14 Table C.1 Summary of maximu

32、m field values beneath high-voltage overhead lines 29 BS EN 50527-1:2010EN 50527-1:2010 6 1 Scope The scope of this European Standard is to provide a procedure in order to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electr

33、omagnetic fields at a workplace. It specifies how to perform a general risk assessment and to determine whether it is necessary to carry out a detailed risk assessment. NOTE 1 This European Standard does not cover indirect effects caused by non active implants. NOTE 2 The the risk of human exposure

34、to EMF considered is only due to malfunctioning of AIMD. Possibilities of AIMD contribution to the risk: e.g. local modification of the distribution of EMF produced by external source or production of own EMF are covered by the respective product standards for the AIMD. Based on specific workplace s

35、tandards it can be determined whether preventive measures/actions must be taken to comply with the provisions of Directive 2004/40/EC. The work situation covered is considered to be under normal working conditions including normal operation, maintenance, cleaning and other situations being part of t

36、he normal work. The frequencies covered are from 0 Hz to 300 GHz. NOTE 3 The European Parliament and Council Directive 2004/40/EC will be transposed into national legislation in all the EU member countries. It is recommended that users of this standard consult the national legislation related to thi

37、s transposition in order to identify the national regulations and requirements. These national regulations and requirements may have additional requirements that are not covered by this standard and take precedence. NOTE 4 Performance requirements with respect to active implantable medical devices a

38、re excluded from the scope of this standard. These are defined in the relevant particular standards for active implantable medical devices. NOTE 5 This standard is written under mandate M/351 and relates to the exposure limits as specified in the Directive 2004/40/EC which is intended to protect wor

39、kers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields (0 Hz to 300 GHz) during their work. However, this and other directives may include additional measures for the protection of specific groups of workers and/or specific workplaces for which

40、the employer is required to investigate other protective measures as a part of the overall risk assessment. 2 Relationship to other standards This European Standard complements the workers exposure assessment standard EN 50499. It provides the general methodology for doing the risk assessment for em

41、ployees bearing an AIMD at the workplace. AIMDs are regulated by Directive 90/385/EEC amended by Directive 2007/47/EC. NOTE Product standards EN 45502-1 and of the EN 45502-2-X series describe the product requirements for different kinds of AIMDs. Different kinds of AIMDs are e.g. pacemaker (EN 4550

42、2-2-1), implantable cardioverter defibrillators (EN 45502-2-2), cochlear implants (EN 45502-2-3), implantable neurostimulators (ISO/PRF 14708-3), implantable infusion pumps (ISO/PRF 14708-4) In situations where the risk assessment following this standard does not lead to a conclusion, complementary

43、provisions for the assessment of workers exposure for different kinds of AIMDs are given in particular standards for these specific AIMDs (see Figure 1). BS EN 50527-1:2010 7 EN 50527-1:2010 Figure 1 Relationship of standards 3 References 3.1 Normative references The following referenced documents a

44、re indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 50499:2008, Procedure for the assessment of the exposure of workers to electromagn

45、etic fields 3.2 Regulatory references Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work, Official Journal L 183, 29/06/1989, p. 1 8 Council Directive 90/385/EEC of 20 June 1990 on the approximation of th

46、e laws of the Member States relating to active implantable medical devices, Official Journal L 189, 20/07/1990, p. 1736 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, 30/07/1

47、999, p. 59 - 70 EN 50499 Determination of workers exposure to electromagnetic fields EN 50527-1 General part covering indirect effects caused by interference with all kinds of AIMD and generic items for subsequent standards for specific AIMD EN 50527-2-1, PacemakerspecificPart: CardiacpacemakersSpec

48、ificworkplace exposure standarde.g. railways(EN 50500)EN 50527-2-2, ICD specificPartEN 50527-2-X, Specificpart Specificworkplace exposure standard e.g. weldingOther standards or requirements may call up the s tandard directly BS EN 50527-1:2010EN 50527-1:2010 8 Directive 2004/40/EC of the European P

49、arliament 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), Official Journal L 159, 30/04/2004, p. 126 Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the