BS EN 60601-2-54-2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy《医用电子设备.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopyBS EN 60601-2-54:20

2、09Incorporating corrigendum April 2010Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSINational forewordThis British Standard is the UK implementation of EN 60601-2-54:2009. It isidentical to IEC 60601-2-54:2009. It supersedes BS EN 60601-2-7:1998 an

3、d BS EN 60601-2-32:1995 which will be withdrawn on 1 August 2012. It partially supersedes BS EN 60601-2-28:1993 which is currently being revised. The UK participation in its preparation was entrusted by Technical CommitteeCH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2,Diagn

4、ostic imaging equipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2010 ISBN 978 0 580 71124 4 ICS 11.0

5、40.50Compliance 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 March 2010.Amendments/corrigenda issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN

6、 60601-2-54:200930 April 2010 Supersession details amendedLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 60601-2-54 NORME EUROPENNE EUROPISCHE NORM September 2009 CENELEC European Committee for Electrotechnical Standardization

7、Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-54:2009 E ICS 1

8、1.040.50 Supersedes EN 60601-2-7:1998, EN 60601-2-28:1993 (partially) and EN 60601-2-32:1994English version Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009) Apparei

9、ls lectromdicaux - Partie 2-54: Exigences particulires pour la scurit de base et les performances essentielles des appareils rayonnement X utiliss pour la radiographie et la radioscopie (CEI 60601-2-54:2009) Medizinische elektrische Gerte - Teil 2-54: Besondere Festlegungen fr die Sicherheit und die

10、 wesentlichen Leistungsmerkmale von Rntgeneinrichtungen fr Radiographie und Radioskopie (IEC 60601-2-54:2009) This European Standard was approved by CENELEC on 2009-08-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Eur

11、opean 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 CENELEC member. This European Standard exists in three official versions (En

12、glish, 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 versions. CENELEC members are the national electrotechnical committees of Austria

13、, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS E

14、N 60601-2-54:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSIEN 60601-2-54:2009 - 2 - Foreword The text of document 62B/735/FDIS, future edition 1 of IEC 60601-2-54, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equi

15、pment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-54 on 2009-08-01. EN 60601-2-54 was developed for use with EN 60601-1:2006. This European Standard supersedes EN 60601-2-7:1998, EN 60601-2-32:1994 and EN 60601-2-28:1993 (partially).

16、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) 2010-05-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-08-01 This Europ

17、ean 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 MDD (93/42/EEC). See Annex ZZ. In this standard, the following print types are used: Requirements and definitions: roma

18、n type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL C

19、APITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2

20、 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so

21、a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is manda

22、tory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. BS EN 60601-2-54:2009Licensed Copy:

23、 Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSI- 3 - EN 60601-2-54:2009 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. Annexes ZA

24、 and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-54:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: 1

25、IEC 60627 NOTE Harmonized as EN 60627:2001 (not modified). 2 IEC 61267 NOTE Harmonized as EN 61267:2006 (not modified). 3 ISO 4090 NOTE Harmonized as EN ISO 4090:2004 (not modified). 10 IEC 60601-2-7 NOTE Harmonized as EN 60601-2-7:1998 (not modified). 11 IEC 60601-2-28 NOTE Harmonized as EN 60601-2

26、-28:1993 (not modified). 12 IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified). 13 IEC 60601-1-8 NOTE Harmonized as EN 60601-1-8:2007 (not modified). 14 IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10:2008 (not modified). 15 IEC 60601-2-43 NOTE Harmonized as EN 60601-2-43:2000 (not

27、modified). _ BS EN 60601-2-54:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSIEN 60601-2-54:2009 - 4 - Annex ZA (normative) Normative references to international publications with their corresponding European publications The following reference

28、d 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 referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modif

29、ications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replace the reference to IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and e

30、ssential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 2007 Replace the reference to IEC 60601-1-3 by: IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Sta

31、ndard: Radiation protection in diagnostic X-ray equipment EN 60601-1-3 2008 Addition: IEC 60336 -1)Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots EN 60336 20052)IEC 60580 2000 Medical electrical equipment - Dose area product meters EN 6058

32、0 2000 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms IEC 60806 -1)Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis EN 60806 20042)IEC 62220-1 2003 Medical electrical equipment - Characteristics of digital X-r

33、ay imaging devices - Part 1: Determination of the detective quantum efficiency EN 62220-1 2004 1)Undated reference. 2)Valid edition at date of issue. BS EN 60601-2-54:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSI- 5 - EN 60601-2-54:2009 Annex

34、 ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been 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

35、Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard.

36、 _ BS EN 60601-2-54:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSI 2 60601-2-54 IEC:2009 CONTENTS INTRODUCTION.6 201.1 Scope, object and related standards .7 201.2 Normative references8 201.3 Terms and definitions9 201.4 General requirements .

37、10 201.5 General requirements for testing of ME EQUIPMENT 11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS11 201.7 ME EQUIPMENT identification, marking and documents .11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT .14 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMEN

38、T and ME SYSTEMS .17 201.10 Protection against unwanted and excessive radiation HAZARDS .21 201.11 Protection against excessive temperatures and other HAZARDS .21 201.12 Accuracy of controls and instruments and protection against hazardous outputs .22 201.13 HAZARDOUS SITUATIONS and fault conditions

39、 22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).22 201.15 Construction of ME EQUIPMENT.22 201.16 ME SYSTEMS 22 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .22 202 Electromagnetic compatibility Requirements and tests .22 203 Radiation protection in diagnostic X-ray e

40、quipment.23 Annexes .58 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS59 Annex AA (informative) Particular guidance and rationale61 Bibliography64 Index of defined terms used in this particular standard65 Figure 203.101 Zone of EXTRA-FOCAL RADIATION

41、 .41 Figure 203.102 Discrepancies in covering the IMAGE RECEPTION AREA.43 Figure 203.103 Discrepancies in visual indication of the X-RAY FIELD .47 Figure 203.104 Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY SOURCE ASSEMBLY below the PATIENT SUPPORT) .55 Figure 203.105 Testing for ST

42、RAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE ASSEMBLY below the PATIENT SUPPORT) 55 Figure 203.106 Testing for STRAY RADIATION (X-RAY BEAM horizontal with X-RAY SOURCE ASSEMBLY above the PATIENT SUPPORT) .56 Figure 203.107 Testing for STRAY RADIATION (X-RAY BEAM vertical with X-RAY SOURCE AS

43、SEMBLY above the PATIENT SUPPORT)57 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 10 Table 203.101 Tests for verifying reproducibility and linearity 29 BS EN 60601-2-54:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSI60601-2-54 IE

44、C:2009 3 Table 203.102 Loadings for testing AUTOMATIC EXPOSURE CONTROLS.31 Table 203.103 ATTENUATION for the measurement of AIR KERMA .33 Table 203.104 ATTENUATION EQUIVALENT of items in the X-RAY BEAM.49 Table 203.105 Application categories 51 Table 203.106 Requirements for PRIMARY PROTECTIVE SHIEL

45、DING 51 Table 203.107 STRAY RADIATION in SIGNIFICANT ZONES OF OCCUPANCY .53 Table 201.C.101 Marking on the outside of ME EQUIPMENT or its parts 59 Table 201.C.102 Subclauses requiring statements in ACCOMPANYING DOCUMENTS.59 BS EN 60601-2-54:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS,

46、09/07/2010 03:14, Uncontrolled Copy, (c) BSI 6 60601-2-54 IEC:2009 INTRODUCTION This particular standard has been prepared to provide, based on IEC 60601-1:2005 (third edition) and its collaterals, a complete set of safety requirements for ME EQUIPMENT for RADIOGRAPHY and RADIOSCOPY. While the previ

47、ously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of X-RAY EQUIPMENT, which consists of a combination of an X-RAY GENERATOR, ASSOCIATED EQUIPMENT and ACCESSORIES. Component functions are addressed as far as ne

48、cessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME EQUIPMENT for RADIOGRAPHY and RADIOSCOPY. Requirements for additional provisions for ME EQUIPMENT for interventional applications are cover

49、ed by IEC 60601-2-43. BS EN 60601-2-54:2009Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 09/07/2010 03:14, Uncontrolled Copy, (c) BSI60601-2-54 IEC:2009 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 201.1 Scope, object and related standards Clause 1 of the general standard1)applies, except