EN 60601-2-43-2010 en Medical electrical equipment - Part 2-43 Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional proceduresBS EN 60601-2-43:2010Incorporating corrigendum July 2014BS EN 60601-2-43:2010National forewordThis British Standard is th

2、e UK implementation of EN 60601-2-43:2010, incorporating corrigendum July 2014. It is identical to IEC 60601-2-43:2010. It supersedes BS EN 60601-2-43:2001, which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice

3、, to Subcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this subcommittee 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

4、 British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 87754 4ICS 11.040.50; 37.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Commi

5、ttee on 31 July 2010.Amendments/corrigenda issued since publicationDate Text affected31 October 2014 Implementation of CENELEC corrigendum July 2014: Supersession details amendedBRITISH STANDARDEUROPEAN STANDARD EN 60601-2-43 NORME EUROPENNE EUROPISCHE NORM June 2010 CENELEC European Committee for E

6、lectrotechnical 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 CENELEC members. Ref.

7、No. EN 60601-2-43:2010 E ICS 11.040.50; 37.040.25 English version Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010) Appareils lectromdicaux - Partie 2-43: Exigences parti

8、culires pour la scurit de base et les performances essentielles des appareils rayonnement X lors dinterventions (CEI 60601-2-43:2010) Medizinische elektrische Gerte - Teil 2-43: Besondere Festlegungen fr die Sicherheit von Rntgeneinrichtungen fr interventionelle Verfahren (IEC 60601-2-43:2010) This

9、European Standard was approved by CENELEC on 2010-06-01. 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 refer

10、ences concerning such national 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 m

11、ember into its own language 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, Hunga

12、ry, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Incorporating corrigendam July 2014 EN 60601-2-43:2010 - 2 - Foreword The text of document 62B/779/FDIS, futur

13、e edition 2 of IEC 60601-2-43, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-43 on 2010-06-01. This European Standard supersedes EN 60601-2-43:2000 . T

14、his particular standard has been revised to provide a complete set of safety requirements for X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, based on EN 60601-1:2006 and relevant collaterals. EN 60601-2-43:2010 is extended to become a system standard for X-RAY EQUIPMENT design

15、ed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration. 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 held responsible for identifying any or all

16、 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) 2011-03-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow)

17、2013-06-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The te

18、xt of the International Standard IEC 60601-2-43:2010 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated: 2 IEC 60601-2-44 NOTE Harmonized as EN 60601-2-44. _ BS EN 60601-2-4

19、3:2010- 3 - EN 60601-2-43:2010 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For u

20、ndated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Y

21、ear Title EN/HD Year Amendment: IEC 60601-1-2 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 2010 IEC 60601-1-3 2008 Medical el

22、ectrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 + corr. March 2008 2010 Addition: IEC 60580 - Medical electrical equipment - Dose area product meters EN 60580 - IEC 6

23、0601-2-54 2009 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopyEN 60601-2-54 2009 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 62220-1 2003 Medical

24、electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency EN 62220-1 2004 BS EN 60601-2-43:2010EN 60601-2-43:2010 - 4 - Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been

25、 prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity

26、 with the specified essential requirements of the Directives concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. BS EN 60601-2-43:2010 2 60601-2-43 IEC:2010 CONTENTS INTRODUCTION.6 201.1 Scope, object and related

27、 standards .7 201.2 Normative references 9 201.3 Terms and definitions9 201.4 General requirements10 201.5 General requirements for testing of ME EQUIPMENT.11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 12 201.7 ME EQUIPMENT identification, marking and documents12 201.8 Protection against el

28、ectrical HAZARDS from ME EQUIPMENT16 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS16 201.10 Protection against unwanted and excessive radiation HAZARDS17 201.11 Protection against excessive temperatures and other HAZARDS17 201.12 Accuracy of controls and instruments and

29、protection against hazardous outputs19 201.13 HAZARDOUS SITUATIONS and fault conditions.22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .22 201.15 Construction of ME EQUIPMENT .22 201.16 ME SYSTEMS 23 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .23 202 Electromagneti

30、c compatibility Requirements and tests .23 203 Radiation protection in diagnostic X-ray equipment .24 Annexes .34 Annex AA (informative) Particular guidance and rationale35 Annex BB (normative) Distribution maps of STRAY RADIATION43 Annex CC (informative) Mapping between this Edition 2 of IEC 60601-

31、2-43 and Edition 1 .47 Bibliography49 Index of defined terms used in this particular standard51 Figure BB.1 Example of isokerma map at 100 cm height in lateral configuration 45 Figure BB.2 Example of isokerma map at 100 cm height in vertical configuration.46 Table 201.101 Additional list of potentia

32、l ESSENTIAL PERFORMANCE to be considered by MANUFACTURER in the RISK MANAGEMENT analysis10 Table 201.102 Other subclauses requiring statements in ACCOMPANYING DOCUMENTS .15 Table AA.1 Examples of prolonged RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for which deterministic effects of IRRADIATIO

33、N are possible 35 Table AA.2 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES for which deterministic effects are unlikely .36 BS EN 60601-2-43:2010 6 60601-2-43 IEC:2010 INTRODUCTION X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES may subject PATIENTS and OPERATORS

34、to higher levels of RADIATION than those which normally prevail during diagnostic X-ray imaging procedures. One consequence for the PATIENT may be the occurrence of deterministic injury when procedures involve the delivery of substantial amounts of RADIATION to localized areas. Another consequence c

35、an be an increased RISK of stochastic effects, such as cancer. These health concerns apply also to the OPERATOR. In addition, for this particular type of equipment, there is a need for availability of critical functions with minimal periods of loss. Interventional procedures of the type envisaged ar

36、e well established in clinical fields such as: invasive cardiology; interventional RADIOLOGY; interventional neuroradiology. These procedures also include many newly developing and emerging applications in a wide range of medical and surgical specialities. NOTE Attention is drawn to the existence of

37、 legislation in some countries concerning RADIOLOGICAL PROTECTION, which may not align with the provisions of this standard. BS EN 60601-2-43:201060601-2-43 IEC:2010 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment fo

38、r interventional procedures 201.1 Scope, object and related standards Clause 1 of the general standard1)applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be sui

39、table for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular: equipment for RADIOTHERAPY; equipment for COMPUTED TOMOGRAPHY; ACCESSORIES intended to be introduced into the PATIENT; mammographic X-RAY EQUIPMENT;

40、 dental X-RAY EQUIPMENT. NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA. NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTER

41、VENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements. NOTE 3 INTERVENTIONAL X-RAY EQ

42、UIPMENT when used in cross-sectional imaging mode (sometimes described as CT-like mode or cone-beam CT) is covered by this particular standard and not by IEC 60601-2-44 22. Additional requirements for operation in CT-like mode or cone-beam CT were not considered in the present standard. INTERVENTION

43、AL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard. If a clause or subclause is specifically intended to be

44、 applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 4 See also 4.2 of the general

45、 standard. 1)The general standard is IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance. 2)Figures in square brackets refer to the Bibliography. BS EN 60601-2-43:2010 8 60601-2-43 IEC:2010 201.1.2 Object Replacement: The object of t

46、his particular standard is: to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the design and manufacture of X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, as defined in 201.3.203. to specify information which is to be provided with such INTERVENTI

47、ONAL X-RAY EQUIPMENT for the assistance of the RESPONSIBLE ORGANIZATION and OPERATOR in managing the RADIATION RISK and equipment failure RISK arising from these procedures which could affect PATIENTS or staff. 201.1.3 Collateral standards Addition: This particular standard refers to those applicabl

48、e collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clause 202 and Clause 203 respectively. IEC 60601-1-8 and IEC 60601-1-10 do not apply. All other published collateral standard

49、s in the IEC 60601-1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 6060