EN 60601-2-44-2009 en Medical electrical equipment - Part 2-44 Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (In.pdf

1、Medical electrical equipmentBS EN 60601-2-44:2009+A1:2012Part 2-44: Particular requirements for the basic safetyand essential performance of X-ray equipment forcomputed tomographyBS EN 60601-2-44:2009+A2:20162-44: Particular requirements for the basic safety d essential performance of X-ray equipmen

2、t for puted tomography (IEC 60601-2-44:2009)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARDNORME EUROPENNE EUROPISCHE NORMCENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komite

3、e fr Elektrotechnische NormungCentral Secretariat:Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELECmembers.Ref. No. EN 60601-2-44:2009 EICS 11.040.50 Supersedes EN 60601-2-44:2009English versionMedical electrical

4、equipment -Part 2-44: Particular requirementsfor the basic safetyand essential performanceof X-ray equipment for computed tomography(IEC 60601-2-44:2009)Appareils electromdicaux -Partie 2-44: Exigences particulirespour la scurit de base et les performances essentiellesdes quipements rayonnement Xde

5、tomodensitomtrie(CEI 60601-2-44:2009)Medizinische elektrische Gerte -Teil 2-44: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Rntgeneinrichtungen fr die Computertomographie(IEC 60601-2-44:2009)This European Standard was approved by CENELEC on 2009-05-0

6、1. CENELEC members are bound to complywith 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 obtaine

7、d onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any otherlanguage made by translation under the responsibility of a CENELEC member into its own language and notifiedto the Central Se

8、cretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, the

9、 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.October 2011October 2012EN 60601-2-44:2009+A1BS EN 60601-2-44:2009+A2:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 60601-2-44:2009+A2:2

10、016. It is identical to IEC 60601-2-44:2009, incorporating amendment 1:2012 and amendment 2:2016. It supersedes BS EN 60601-2-44:2009+A1:2012 which will be withdrawn on 5 May 2019.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating change

11、s 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/62/2, Diagnostic imaging equipment.A lis

12、t 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 Institution 2016. Published by BSI Standar

13、ds Limited 2016ISBN 978 0 580 90493 6ICS 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 July 2009Amendments/corrigenda issued since publicationDate

14、Text affected31 March 2012 Implementation of CENELEC amendment A11:2012: Annex ZZ replaced30 June 2013 Implementation of IEC amendment 1:2012 with CENELEC endorsement A1:201231 July 2016 Implementation of IEC amendment 2:2016 with CENELEC endorsement A2:2016. Annex ZA amendedEUROPEAN STANDARD NORME

15、EUROPENNE EUROPISCHE NORMCENELEC European Committee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCentral Secretariat:Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by a

16、ny means reserved worldwide for CENELECmembers.Ref. No. EN 60601-2-44:2009 EICS 11.040.50 Supersedes EN 60601-2-44:2009English versionMedical electricalequipment - Part 2-44: Particular requirementsfor the basic safetyand essential performanceof X-ray equipment for computed tomography(IEC 60601-2-44

17、:2009)Appareils electromdicaux -Partie 2-44: Exigences particulires pour la scurit de base et les performances essentielles des quipements rayonnement Xde tomodensitomtrie(CEI 60601-2-44:2009)Medizinische elektrische Gerte -Teil 2-44: Besondere Festlegungen fr die Sicherheit einschlielich der wesent

18、lichen Leistungsmerkmale von Rntgeneinrichtungen fr die Computertomographie(IEC 60601-2-44:2009)This European Standard was approved by CENELEC on 2009-05-01. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard

19、the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, G

20、erman). A version in any otherlanguage made by translation under the responsibility of a CENELEC member into its own language and notifiedto the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria

21、, Cyprus, theCzech 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.October 2011October 2012EN

22、 60601-2-44:2009+A1EN 60601-2-44:2009+A2June 2016Foreword The text of document 62B/727/FDIS, future edition 3 of IEC 60601-2-44, prepared by SC 62B, Diagnosticimaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to theIEC-CENELEC parallel vote and was approved by

23、CENELEC asEN 60601-2-44 on 2009-05-01.This European Standardsupersedes EN 60601-2-44:2001 + A1:2003.EN 60601-2-44:2009 constitutes a technical revision primarily related to RADIATION protection and control.The following dates were fixed: latest date by which the EN has to be implemented at national

24、level by publication of an identicalnational standard or by endorsement (dop) 2010-02-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2012-05-01This European Standardhas been prepared under a mandate given to CENELEC by the EuropeanCommission and the

25、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: roman type. Test specifications: italic type. Informative material appearing outside of tables,such as n

26、otes, examples and references: in smaller type. Normative text oftables 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 the seventeen n

27、umbered divisions within the table of contents,inclusive of allsubdivisions (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 ofClause 7).References to clauses within this standard are preceded by the

28、term “Clause” followed by the clausenumber. 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 combinationof the conditions is true.The verbal forms used in this standard confor

29、m 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 thisstandard; “should” means that compliance with a requirement or a test is recommende

30、d but is not mandatory forcompliance with this standard; “may”is used to describe a permissible way to achieve compliance with a requirement or test. Annexes ZA and ZZ have been added by CENELEC._BS EN 60601-2-44:2009+A11:2011 EN 60601-2-44:2009+A11:2011 (E) 2 BS EN 60601-2-44:2009+A1:2012EN 60601-2

31、-44:2009+A1:2012 (E) 2 Endorsement noticeThe textofthe International Standard IEC 60601-2-44:2009 was approved by CENELEC asa 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 NOTE Harm

32、onized as EN 60601-2-7:1998 (not modified).IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified).IEC 60613 NOTE Harmonized as EN 60613:1990 (not modified)._Foreword to amendment A11 This document (EN 60601-2-44:2009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medi

33、cal practice”. The following dates are fixed: null latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-10-01 null latest date by which the national standards conflicting with this document have to be

34、 withdrawn (dow) 2014-10-01 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. BS EN 60601-2-44:2009+A11:2011 EN 60601-2-44:2009+A11:2011

35、 (E) 3 Endorsement noticeThe textofthe International Standard IEC 60601-2-44:2009 was approved by CENELEC asa 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 NOTE Harmonized as EN 606

36、01-2-7:1998 (not modified).IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified).IEC 60613 NOTE Harmonized as EN 60613:1990 (not modified)._Foreword to amendment A11 This document (EN 60601-2-44:2009/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice”. T

37、he following dates are fixed: null latest date by which this document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-10-01null latest date by which the national standards conflicting with this document have to be withdrawn (dow)

38、2014-10-01Attention 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. BS EN 60601-2-44:2009+A11:2011 EN 60601-2-44:2009+A11:2011 (E) 3 BS EN 60601

39、-2-44:2009+A1:2012EN 60601-2-44:2009+A1:2012 (E) 3 EN 60601-2-44:2009/A1:2012 - 2 - Foreword The text of document 62B/869/FDIS, future amendment 1 to edition 3 of IEC 60601-2-44, prepared by SC 62B “Diagnostic imaging equipment“ of IEC TC 62 “Electrical equipment in medical practice“ was submitted t

40、o the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-44:2009/A1:2012. The following dates are fixed: null latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2013-07-04 null latest date by

41、 which the national standards conflicting with the document have to be withdrawn (dow) 2015-10-04 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 pat

42、ent 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 of EU Directive(s). Endorsement notice The text of the International Standard IEC 60601-2-44:2009/A1:2012 was approved

43、by CENELEC as a European Standard without any modification. EN 60601-2-44:2009/A1:2012 - 2 - Foreword The text of document 62B/869/FDIS, future amendment 1 to edition 3 of IEC 60601-2-44, prepared by SC 62B “Diagnostic imaging equipment“ of IEC TC 62 “Electrical equipment in medical practice“ was su

44、bmitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-44:2009/A1:2012. The following dates are fixed: null latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2013-07-04 null lates

45、t date by which the national standards conflicting with the document have to be withdrawn (dow) 2015-10-04 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

46、 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 of EU Directive(s). Endorsement notice The text of the International Standard IEC 60601-2-44:2009/A1:2012 was

47、approved by CENELEC as a European Standard without any modification. Foreword to amendment A1BS EN 60601-2-44:2009+A2:2016EN 60601-2-44:2009+A2:2016 (E)Foreword The text of document 62B/727/FDIS, future edition 3 of IEC 60601-2-44, prepared by SC 62B, Diagnosticimaging equipment, of IEC TC 62, Elect

48、rical equipment in medical practice, was submitted to theIEC-CENELEC parallel vote and was approved by CENELEC asEN 60601-2-44 on 2009-05-01.This European Standardsupersedes EN 60601-2-44:2001 + A1:2003.EN 60601-2-44:2009 constitutes a technical revision primarily related to RADIATION protection and

49、 control.The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identicalnational standard or by endorsement (dop) 2010-02-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2012-05-01This European Standardhas been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and covers essential requirements of EC Directive MD