BS EN 60601-2-45-2011 Medical electrical equipment Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotac.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipmentPart 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic device

2、sBS EN 60601-2-45:2011Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/08/2011 07:21, Uncontrolled Copy, (c) BSINational forewordThis British Standard is the UK implementation of EN 60601-2-45:2011. It is identical to IEC 60601-2-45:2011. It supersedes BS EN 60601-2-45:2001 which is withdra

3、wn.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication do

4、es not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2011ISBN 978 0 580 60121 7 ICS 11.040.50Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authorit

5、y of the Standards Policy and Strategy Committee on 31 May 2011.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60601-2-45:2011Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/08/2011 07:21, Uncontrolled Copy, (c) BSIEUROPEAN STANDARD EN 60601-2-45 NORME

6、EUROPENNE EUROPISCHE NORM March 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 exploitation in an

7、y form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-45:2011 E ICS 11.040.50 Supersedes EN 60601-2-45:2001English version Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment an

8、d mammographic stereotactic devices (IEC 60601-2-45:2011) Appareils lectromdicaux - Partie 2-45: Exigences particulires pour la scurit de base et les performances essentielles des appareils de mammographie rayonnement X et des appareils mammographiques strotaxiques (CEI 60601-2-45:2011) Medizinische

9、 elektrische Gerte - Teil 2-45: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Rntgen-Mammographiegerten und mammographischen Stereotaxie-Einrichtungen (IEC 60601-2-45:2011) This European Standard was approved by CENELEC on 2011-03-17. CENELEC members a

10、re 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 national standards may be obtained on application to

11、 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 language and notified to the Central Secretariat has th

12、e 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, Italy, Latvia, Lithuania, Luxembourg, Malta, the Net

13、herlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 60601-2-45:2011Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/08/2011 07:21, Uncontrolled Copy, (c) BSIEN 60601-2-45:2011 - 2 - Foreword The text of document 62B/817/F

14、DIS, future edition 3 of IEC 60601-2-45, 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 60601-2-45 on 2011-03-17. Attention is drawn to the possibility that som

15、e 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 such patent rights. This European Standard supersedes EN 60601-2-45:2001. EN 60601-2-45:2011 has been aligned to EN 60601-1:2006 and to EN 60601-1-3:2008 +

16、 corrigendum March 2010. Further modifications have been made with respect to the current technology of MAMMOGRAPHIC X-RAY EQUIPMENT. 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

17、 (dop) 2011-12-17 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2014-03-17 In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tabl

18、es, 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 CAPITALS. In referring to the structure of this standard, the term “clause” means one of

19、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 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard

20、 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 a statement is true if any combination of the conditions is true. The verbal forms u

21、sed 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 mandatory for compliance with this standard; “should” means that compliance with a requir

22、ement 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 60601-2-45:2011Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/08/2011 07:21, Uncontrolled Copy, (c) BS

23、I- 3 - EN 60601-2-45:2011 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. This European Standard has been prepared under a mandate given to CENELEC by the European Comm

24、ission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/423/EEC). See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-45:2011 was approved by CENELEC as a European Standar

25、d without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601-2-7:1998 NOTE Harmonized as EN 60601-2-7:1998 (not modified). IEC 60601-2-28:2010 NOTE Harmonized as EN 60601-2-28:2010 (not modified). IEC 60601-2-32:19

26、94 NOTE Harmonized as EN 60601-2-32:1994 (not modified). IEC 60664-1:2007 NOTE Harmonized as EN 60664-1:2007 (not modified). ISO 4090:2001 NOTE Harmonized as EN ISO 4090:2004 (not modified). ISO 12052 NOTE Harmonized as EN ISO 12052 (not modified). _ BS EN 60601-2-45:2011Licensed Copy: Wang Bin, ISO

27、/EXCHANGE CHINA STANDARDS, 12/08/2011 07:21, Uncontrolled Copy, (c) BSIEN 60601-2-45:2011 - 4 - Annex ZA (normative) Normative references to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this docu

28、ment. 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 modifications, indicated by (mod), the relevant EN/HD applies. Anne

29、x ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replace IEC 60601-1-2 and IEC 60601-1-3 by: IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic c

30、ompatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 2010 IEC 60601-1-3 2008 Medical electrical 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

31、2008 2010 Add: IEC 60336 2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots EN 60336 2005 IEC 60613 2010 Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis EN 60613 2010 IEC/TR 60788 2004 Medical electri

32、cal equipment - Glossary of defined terms - - IEC 61223-3-2 2007 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment EN 61223-3-2 2008 IEC 62220-1-2 2007 Medical electrical equipment - Characteristics of dig

33、ital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors use in mammography EN 62220-1-2 2007 ISO 9236-3 1999 Photography - Sensitometry of screen/film systems for medical radiography - Part 3: Determination of sensitometric curve shape, speed and average

34、gradient for mammography - - BS EN 60601-2-45:2011Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/08/2011 07:21, Uncontrolled Copy, (c) BSI- 5 - EN 60601-2-45:2011 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a ma

35、ndate 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 with the specified

36、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. BS EN 60601-2-45:2011Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/08/2011 07:21, Uncontrolled Copy, (c) BSI

37、 2 60601-2-45 IEC:2011 CONTENTS INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references . 9 201.3 Terms and definitions. 10 201.4 General requirements 11 201.5 General requirements for testing of ME EQUIPMENT . 12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS

38、12 201.7 ME EQUIPMENT identification, marking and documents 12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 19 201.10 Protection against unwanted and excessive radiation HAZARDS 21 201.11 Protection agai

39、nst excessive temperatures and other HAZARDS 22 201.12 Accuracy of controls and instruments and protection against hazardous outputs . . 22 201.13 Hazardous situations and fault conditions 22 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 22 201.15 Construction of ME EQUIPMENT . . 22 201.16 M

40、E SYSTEMS . 22 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 23 202 Electromagnetic compatibility Requirements and tests . 23 203 Radiation protection in diagnostic X-ray equipment . . 23 Annex AA (informative) Particular guidance and rationale 46 Bibliography . 48 Index of def

41、ined terms used in this particular standard. 49 Table 201.101 Distributed ESSENTIAL PERFORMANCE requirements 11 Table 203.101 Minimum values of TOTAL FILTRATION and factors for determining the minimum AIR KERMA RATE 38 BS EN 60601-2-45:2011Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 12/08

42、/2011 07:21, Uncontrolled Copy, (c) BSI 6 60601-2-45 IEC:2011 INTRODUCTION The third edition of this particular standard has been prepared to provide a complete set of safety requirements for MAMMOGRAPHIC X-RAY EQUIPMENT, based on IEC 60601-1:2005 (3rdedition) and its collaterals. This particular st

43、andard addresses the system level of MAMMOGRAPHIC X-RAY EQUIPMENT, which consists of a combination of an X-RAY GENERATOR, associated equipment and ACCESSORIES. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered

44、 to provide for a practical degree of safety in the operation of MAMMOGRAPHIC X-RAY EQUIPMENT. Like the previous edition of this Part 2-45, the present third edition includes requirements on HIGH-VOLTAGE GENERATORS for mammography. BS EN 60601-2-45:2011Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STA

45、NDARDS, 12/08/2011 07:21, Uncontrolled Copy, (c) BSI60601-2-45 IEC:2011 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 201.1 Scope, object and related standards Cla

46、use 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 MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT. NOTE 1 This inclu

47、des MAMMOGRAPHIC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or integrated storage phosphor subsystems. Excluded from the scope of this document are: reconstructive tomography modes of operation; diagnostic consoles; picture archiving and communication systems (PACS); non-integrat

48、ed storage phosphor readers; hard copy cameras; films, screens and cassettes; computer aided detection (CAD); devices for performing core biopsy and other biopsy instruments; modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography); If a clause

49、or subclause is specifically intended to be applicable to ME 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 ME EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3rdedition scheme for MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES. 201.1.2 Object Replacement: The object of