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

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1、BSI Standards PublicationMedical electrical equipmentPart 2-45: Particular requirements for thebasic safety and essential performance ofmammographic X-ray equipment andmammographic stereotactic devicesBS EN 60601-2-45:2011+A1:2015BS EN 60601-2-45:2011+A1:2015 BRITISH STANDARDNational forewordThis Br

2、itish Standard is the UK implementation of EN 60601-2-45:2011+A1:2015. It is identical to IEC 60601-2-45:2011, incorporating amendment 1:2015. It supersedes BS EN 60601-2-45:2011 which will be withdrawn on 23 July 2018.The start and finish of text introduced or altered by amendment is indicated in t

3、he text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by .The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/6

4、2/2, 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 British Standards Ins

5、titution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 79944 0ICS 11.040.50Compliance 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 May 2011.Amendments/c

6、orrigenda issued since publicationDate Text affected31 October 2015 Implementation of IEC amendment 1:2015 with CENELEC endorsement A1:2015. Annex ZA updatedEUROPEAN STANDARD EN 60601-2-45 NORME EUROPENNE EUROPISCHE NORM March 2011 CENELEC European Committee for Electrotechnical Standardization Comi

7、t Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-45:2011 E ICS 11.040.

8、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 and mammographic stereotactic devices (IEC 60601-2-45:2011) Appareils lectromdicaux - Partie 2-45: Exigence

9、s 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 elektrische Gerte - Teil 2-45: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen L

10、eistungsmerkmale 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 are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving th

11、is 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 the Central Secretariat or to any CENELEC member. This European Standard exists in three official versio

12、ns (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 the same status as the official versions. CENELEC members are the national electrotechnical committees of A

13、ustria, Belgium, Bulgaria, Croatia, 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 Unite

14、d Kingdom. BS EN 60601-2-45:2011EN 60601-2-45:2011+A1September 2015BS EN 60601-2-45:2011+A1:2015EN 60601-2-45:2011 - 2 - Foreword The text of document 62B/817/FDIS, future edition 3 of IEC 60601-2-45, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical pra

15、ctice, 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 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

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

17、llowing 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) 2011-12-17 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2014-03-17 In this standard

18、, the following print types are used: Requirements and definitions: roman 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 O

19、F 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 the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g., Clause 7 includes subclauses 7.1, 7.2, e

20、tc.); “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 are preceded by the term “clause” followed by the clause number. References to subclauses within this particular standard are by number onl

21、y. 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 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 auxilia

22、ry verb: “shall” means that compliance with a requirement or a test is mandatory 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 achiev

23、e compliance with a requirement or test. BS EN 60601-2-45:2011- 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 p

24、repared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/423/EEC). See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC

25、60601-2-45:2011 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: IEC 60601-2-7:1998 NOTE Harmonized as EN 60601-2-7:1998 (not modified). IEC 60601-2-28:2010 NOTE Harmo

26、nized as EN 60601-2-28:2010 (not modified). IEC 60601-2-32:1994 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 m

27、odified). _ BS EN 60601-2-45:2011- 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

28、 to CENELEC by the European Commission 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

29、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: 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 (

30、not modified). IEC 60601-2-32:1994 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:

31、2011BS EN 60601-2-45:2011+A1:2015EN 60601-2-45:2011+A1:2015 2 EN 60601-2-45:2011/A1:2015 2 European foreword The text of document 62B/917/CDV, future IEC 60601-2-45:2011/A1, prepared by SC 62B “Diagnostic imaging equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the

32、 IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-45:2011/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-04-23 latest date by which the nati

33、onal standards conflicting with the document have to be withdrawn (dow) 2018-07-23 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. Thi

34、s document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-45:2011. Endorseme

35、nt notice The text of the International Standard IEC 60601-2-45:2011/A1:2015 was approved by CENELEC as a European Standard without any modification. In the Bibliography of EN 60601-2-45:2011, the following note has to be added for the standard indicated: IEC 61223-3-2:2007 NOTE Harmonized as EN 612

36、23-3-2:2008 (not modified). - 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 C

37、ENELEC by the European Commission 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 CE

38、NELEC as a European Standard 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 m

39、odified). IEC 60601-2-32:1994 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 60601-2-45:2011-

40、 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 Commis

41、sion 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 Standard

42、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 60601-2-32:1994

43、 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 60601-2-45:2011BS EN 60601-2-45:2011+A1:2015E

44、N 60601-2-45:2011+A1:2015 3 EN 60601-2-45:2011/A1:2015 2 European foreword The text of document 62B/917/CDV, future IEC 60601-2-45:2011/A1, 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 app

45、roved by CENELEC as EN 60601-2-45:2011/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-04-23 latest date by which the national standards conflicting with th

46、e document have to be withdrawn (dow) 2018-07-23 Attention is drawn to the possibility that some of the elements of this document may 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

47、 a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-45:2011. Endorsement notice The text of the Internat

48、ional Standard IEC 60601-2-45:2011/A1:2015 was approved by CENELEC as a European Standard without any modification. In the Bibliography of EN 60601-2-45:2011, the following note has to be added for the standard indicated: IEC 61223-3-2:2007 NOTE Harmonized as EN 61223-3-2:2008 (not modified). Forewo

49、rd to amendment A1- 5 - EN 60601-2-45:2011 Annex 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 Annex I of the EC Directive 93/42/EEC. Compliance with this standard provides one means of c