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

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1、BS EN 50527-1:2016Procedure for the assessmentof the exposure toelectromagnetic fields ofworkers bearing activeimplantable medical devicesPart 1: GeneralBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 50527-1:2016 BRITISH STANDARDNational forewordThis British S

2、tandard is the UK implementation of EN 50527-1:2016. It supersedes BS EN 50527-1:2010 which will be withdrawn on 4 July 2019.The UK participation in its preparation was entrusted to Technical Committee GEL/106, Human exposure to low frequency and high frequency electromagnetic radiation.A list of or

3、ganizations 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 Standards Institution 2017.Published by BSI Standards Limited

4、2017ISBN 978 0 580 89770 2 ICS 11.040.40; 13.100; 13.280 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 on 31 January 2017.Amendments/corrigenda issued since publi

5、cationDate T e x t a f f e c t e dBS EN 50527-1:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50527-1 December 2016 ICS 11.040.40; 13.100; 13.280 Supersedes EN 50527-1:2010 English Version Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active imp

6、lantable medical devices - Part 1: General Procdure pour lvaluation de lexposition des travailleurs porteurs de dispositifs mdicaux implantables actifs aux champs lectromagntiques - Partie 1 : Gnralits Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinisch

7、en Gerten (AIMD) gegenber elektromagnetischen Feldern - Teil 1: Allgemeine Festlegungen This European 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 sta

8、tus 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, Frenc

9、h, 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,

10、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, Portugal, Romania, Slovakia, Slovenia, Spain, Sw

11、eden, 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: Avenue Marnix 17, B-1000 Brussels 2016 CENELEC All rights of explo

12、itation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 50527-1:2016 E BS EN 50527-1:2016EN 50527-1:2016 (E) 2 Contents Page European foreword . 4 1 Scope 6 2 Normative references 7 3 Terms and definitions . 7 4 Risk assessment . 8 4.1 Risk assessment procedure 8 4.1

13、.1 Introduction 8 4.1.2 Workplace equipment 9 4.1.3 Previously uninfluenced behaviour 9 4.1.4 Specific warnings . 10 4.2 Documentation and information for the AIMD-Employee 11 4.3 Maintaining the risk assessment . 12 5 Equipment at workplaces . 12 5.1 General approach 12 5.2 Equipment with recommend

14、ations restricting use 13 5.2.1 General recommendations 13 5.2.2 Compliant workplaces and exceptions 13 6 Special cases . 17 7 AIMD-Employees with more than one AIMD . 17 8 Documentation 17 Annex A (normative) Specific risk assessment . 18 A.1 General 18 A.2 Non-clinical approach 18 A.2.1 Assessment

15、 of the exposure situation . 18 A.2.2 Assessment of the AIMD immunity 18 A.2.3 Assessment of the compatibility 18 A.2.4 Assessment of the risk of incompatibility . 19 A.3 Clinical approach . 19 A.4 Documentation of the specific assessment . 19 Annex B (informative) Documenting the risk assessment .

16、20 B.1 Introduction 20 B.2 Workplace compliance documentation form . 20 B.2.1 General 20 B.2.2 Assessment . 21 B.2.3 Conclusion . 21 B.3 Previously uninfluenced behaviour . 22 B.3.1 General information . 22 B.3.2 Assessment . 22 B.3.3 Conclusion . 23 B.4 Documenting the detailed risk assessment 23 B

17、S EN 50527-1:2016 EN 50527-1:2016 (E) 3 B.4.1 General information . 23 B.4.2 Assessment . 23 B.4.3 Exposure situation (see A.2.1) . 24 B.4.4 Compliance demonstration 24 Annex C (informative) Specific electromagnetic environments . 25 C.1 Railways 25 C.2 Workplace power transmission and distribution

18、25 C.2.1 General 25 C.2.2 Field levels in public exposure situations. 25 C.2.3 Sensitivity of AIMDs to 50 Hz fields . 26 C.2.4 Risk assessment in occupational situations 26 C.3 Broadcasting . 26 Annex D (informative) Theoretical considerations 27 D.1 Introduction 27 D.2 Brief summary of exposure lim

19、its for persons without implant 27 D.3 General considerations about electromagnetic fields . 28 D.4 General considerations about AIMDs . 29 D.4.1 General 29 D.4.2 Devices with sensing leads 29 D.4.3 Devices with stimulating leads . 29 D.4.4 Devices without leads 29 D.4.5 Devices using RF or inductiv

20、e coupling . 29 D.4.6 Considerations for minimizing transient exposure . 30 D.5 Description of electromagnetic interference effects 30 D.6 Model to assess the possibility of induction of AIMD response 30 D.7 Possibility of induced AIMD response . 31 D.8 Possible AIMD responses to interference . 32 B

21、ibliography 34 Figures Figure 1 Structure of the EN 50527 family of standards 6 Figure 2 Risk assessment process 11 Figure D.1 Field strength Distance ratio . 28 Figure D.2 Near field far field transition for sources smaller than half wavelength in size 28 Figure D.3 Entire model to assess the possi

22、bility of induction of AIMD response 30 Figure D.4 Simplified model to assess the possibility of AIMD response in special cases 31 Tables Table 1 Compliant workplaces and equipment with exceptions 13 Table C.1 Summary of maximum field values beneath high-voltage overhead lines at 1 m above ground .

23、26 BS EN 50527-1:2016EN 50527-1:2016 (E) 4 European foreword This document (EN 50527-1:2016) 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 implementedat national level by publication of

24、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 50527-1:2010. Attention is drawn to the possibility that some of the elements of this document ma

25、y be the subject of patent rights. CENELEC and/or CEN 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, and supports essential requirements

26、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 workers bearing active implantable medical devices Part 1: General; EN 50527-2-1, Procedure for the assessment of the exposure to electro

27、magnetic fields of workers bearing active implantable medical devices Part 2-1: Specific assessment for workers with cardiac pacemakers; prEN 50527-2-2, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 2-2: Specific ass

28、essment for workers with implantable cardioverter defibrillators1). EN 50527-1:2016 includes the following significant technical changes with respect to EN 50527-1:2010: updates to recognize the Occupational Exposure Directive 2013/35/EU; inclusion of EN 50527-2-2 within the family of standards for

29、AIMD-Employee assessment; former Clause 2 (Relationship to other standards) was removed, subsequent renumbering of all laterclauses; update of normative references to the “state of the art”, including the removal of EN 50499; clarification of the defined term “transient exposure”; numerous editorial

30、 changes to improve readability and clarity; correction of minor technical issues related to the general and specific assessment procedures; update to the Bibliography. 1) Currently at drafting stage.BS EN 50527-1:2016 EN 50527-1:2016 (E) 5 The human exposure to electromagnetic fields (EMF) is regul

31、ated 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 in their obligation

32、to govern public health and safety. For Occupational Exposure Directive 2013/35/EU 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 occupational exposure limits

33、of the ICNIRP guidelines. Common to the European Recommendation and Directive 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

34、nervous system or induced voltages across membranes are the limiting factors whereas in the higher frequency area tissue heating by absorption needs to be limited. The Occupational Exposure Directive 2013/35/EU in Article 4.5 additionally obliges the employer to investigate during the risk assessmen

35、t process indirect effects like interference 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 sur

36、rounding the implant, or the behaviour of the device may be interfered with (for examples see D.8 in Annex D of this standard). 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 implantati

37、on. The clinical relevance of interference may depend on the duration 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

38、consists of a simplified risk analysis, followed where necessary, by a more extensive risk assessment. 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 f

39、oreseeable environmental conditions such as magnetic fields, external electromagnetic interference effects, and electrostatic discharge. EN 50499 originally introduced a concept of identifying equipment not likely to cause exposure to EMF above the limit values. This standard follows this approach b

40、ut some of the identified equipment for general purpose assessment needs 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

41、 may be interfered with even by short pulses. BS EN 50527-1:2016EN 50527-1:2016 (E) 6 1 Scope This European Standard provides a procedure to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a workplace

42、. It describes how a general risk assessment should be performed and determines 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 risk of human exposure to EMF considered is only du

43、e 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 standards it can be determin

44、ed whether preventive measures/actions need to be taken to comply with the provisions of Directive 2013/35/EU. The work situation covered is considered to be under normal working conditions including normal operation, maintenance, cleaning and other situations being part of the normal work. The freq

45、uencies covered are from 0 Hz to 300 GHz. The European Parliament and Council Directive 2013/35/EU 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 this transposition in order to ide

46、ntify 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 3 Performance requirements with respect to active implantable medical devices are excluded from the Scope of t

47、his standard. These are defined in the relevant particular standards for active implantable medical devices. The risk assessment described in this standard is only required if an AIMD-Employee is present. Active Implantable Medical Devices (AIMDs) are regulated by Directive 90/385/EEC and the amendm

48、ents to it. NOTE 4 Product standards EN 455021 and of the EN 455022-X series describe the product requirements for different kinds of AIMDs. Different kinds of AIMDs are e.g. pacemaker (EN 4550221), implantable cardioverter defibrillators (EN 4550222), cochlear implants (EN 4550223), implantable neu

49、rostimulators (ISO 14708-3), implantable infusion pumps (ISO 14708-4). In situations where the risk assessment following this standard does not lead to a conclusion, complementary provisions for the assessment of workers exposure for different kinds of AIMDs are given in particular standards for these specific AIMDs (see Figure 1). Figure 1 Structure of the EN 50527 family of standards EN 50527-1 General part covering indirect effects caused by interference with all kinds of AIMD and generic items fo