EN 60613-2010 en Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis《医疗诊断用X射线管组件的电气和负载特性》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationElectrical and loading characteristics of X-ray tubeassemblies for medical diagnosisBS EN 60613:2010National forewordThis British Standard is the UK implementation of EN 60613:20

2、10. It is identical to IEC 60613:2010. It supersedes BS 6058:1989 which will be withdrawn on 1 April 2013.The UK participation in its preparation was entrusted by Technical CommitteeCH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2,Diagnostic imaging equipment.A list of organi

3、zations 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 2010ISBN 978 0 580 54178 0ICS 11.040.50Compliance with a British Standard ca

4、nnot confer immunity fromlegal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 31 May 2010.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN 60613:2010EUROPEAN STANDARD EN 60613 NORME EUROPENNE EUR

5、OPISCHE NORM April 2010 CENELEC European Committee for Electrotechnical 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

6、 any means reserved worldwide for CENELEC members. Ref. No. EN 60613:2010 E ICS 11.040.50 Supersedes EN 60613:1990English version Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis (IEC 60613:2010) Caractristiques lectriques et de charge des gaines quipes pour diag

7、nostic mdical (CEI 60613:2010) Elektrische und Belastungs-Kennwerte von Rntgenstrahlern fr die medizinische Diagnostik (IEC 60613:2010) This European Standard was approved by CENELEC on 2010-04-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the cond

8、itions 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 the Central Secretariat or to any CENELEC member. This European Standard exists in t

9、hree 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 the same status as the official versions. CENELEC members are the national electrotechn

10、ical 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 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switz

11、erland and the United Kingdom. BS EN 60613:2010EN 60613:2010 - 2 - Foreword The text of document 62B/774/FDIS, future edition 3 of IEC 60613, 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 w

12、as approved by CENELEC as EN 60613 on 2010-04-01. This standard supersedes EN 60613:1990. It constitutes a technical revision. EN 60613:2010 has been adapted to apply to the present technology. Attention is drawn to the possibility that some of the elements of this document may be the subject of pat

13、ent rights. CEN and CENELEC shall not be held responsible for identifying any or all 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) 2011-01-01 latest date

14、 by which the national standards conflicting with the EN have to be withdrawn (dow) 2013-04-01 Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60613:2010 was approved by CENELEC as a European Standard without any modification. _ BS EN 60613:2010- 3

15、 - EN 60613:2010 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 undated referen

16、ces, 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. Publication Year Title EN/HD Year IEC 60601-1 2005 Medical electrical equipment - P

17、art 1: General requirements for basic safety and essential performance EN 60601-1 2006 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 20

18、08 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - BS EN 60613:2010 2 60613 IEC:2010 CONTENTS 1 Scope.5 2 Normative references .5 3 Terms and definitions .5 4 Presentation of the electrical characteristic 8 4.1 X-RAY TUBE VOLTAGE 8 4.2 NOMINAL X-RAY TUBE VOLTAGE 8 4.3

19、X-RAY TUBE CURRENT8 4.4 CATHODE EMISSION CHARACTERISTIC8 4.5 ENVELOPE characteristics.9 4.5.1 ENVELOPE CURRENT 9 4.5.2 ENVELOPE VOLTAGE 9 5 LOADING of an X-RAY TUBE.9 5.1 LOADING TIME .9 5.1.1 Units9 5.1.2 Measurement.9 5.2 CYCLE TIME 9 6 Input power 9 6.1 ANODE INPUT POWER.9 6.2 NOMINAL ANODE INPUT

20、 POWER .9 6.3 NOMINAL RADIOGRAPHIC ANODE INPUT POWER .10 6.4 NOMINAL CT ANODE INPUT POWER10 6.5 X-RAY TUBE ASSEMBLY INPUT POWER 10 6.6 NOMINAL CONTINUOUS INPUT POWER.10 6.7 CONTINUOUS ANODE INPUT POWER .10 6.8 CT SCAN POWER INDEX (CTSPI).10 6.9 NOMINAL CT SCAN POWER INDEX (NOMINAL CTSPI) .10 7 RADIO

21、GRAPHIC RATINGS10 7.1 General .10 7.2 SINGLE LOAD RATING .10 7.3 SERIAL LOAD RATING .10 8 Presentation of data .11 Annex A (informative) Rationale and historical background12 Annex B (informative) Measurement of the X-RAY TUBE CURRENT17 Bibliography18 Index of defined terms 19 Figure A.1 Example: SI

22、NGLE LOAD RATING chart showing CTSPI calculation area for scan time interval of 1 s to 25 s 14 Figure A.2 Example: SINGLE LOAD RATING curves for two different CT tubes, both having the same value of NOMINAL CT ANODE INPUT POWER 15 Figure B.1 Electrical schematic of X-RAY TUBE CURRENT measurement .17

23、 BS EN 60613:201060613 IEC:2010 5 ELECTRICAL AND LOADING CHARACTERISTICS OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS 1 Scope This International Standard applies to X-RAY TUBE ASSEMBLIES either with a rotating ANODE X-RAY TUBE or a stationary ANODE X-RAY TUBE, intended for use in medical diagnosis

24、. For an X-RAY TUBE HEAD, its X-RAY TUBE ASSEMBLY aspects are also within the scope. This International Standard covers performance-related definitions and conditions of electrical and LOADING characteristics of X-RAY TUBE ASSEMBLIES in relation to their behaviour during and after energization and,

25、where appropriate, methods of presentation and measurement of these characteristics. This International Standard is therefore relevant for the MANUFACTURER and the RESPONSIBLE ORGANIZATION. NOTE “Measurement“ in this standard is always related to practical use. Consequently, “measurement“ is meant t

26、o consume only a negligible part of the life of the X-RAY TUBE ASSEMBLY. 2 Normative references The following referenced 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 reference

27、d document (including any amendments) applies. IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-3:2008, Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral

28、Standard: Radiation protection in diagnostic X-ray equipment IEC/TR 60788:2004, Medical electrical equipment Glossary of defined terms (available only in English) 3 Terms and definitions For the purposes of this document, the terms and definitions given in IEC/TR 60788:2004, IEC 60601-1:2005 and IEC

29、 60601-1-3:2008 and the following apply. 3.1 X-RAY TUBE VOLTAGE potential difference applied to an X-RAY TUBE between the ANODE and the CATHODE. Usually X-RAY TUBE VOLTAGE is expressed by its peak value in kilovolts (kV) IEC 60601-1-3:2008, 3.88 3.2 NOMINAL X-RAY TUBE VOLTAGE highest permitted X-RAY

30、 TUBE VOLTAGE for SPECIFIC operating conditions IEC 60601-1-3:2008, 3.42 BS EN 60613:2010 6 60613 IEC:2010 NOTE 1 For different operating conditions of the X-RAY TUBE, for example continuous operation, intermittent operation, short-time operation, different types of X-RAY TUBE HOUSINGS, there may be

31、 different values of the above NOMINAL X-RAY TUBE VOLTAGE. NOTE 2 Additionally, values may be given for the highest permitted potential difference between ANODE and earth and between CATHODE and earth. 3.3 X-RAY TUBE CURRENT electric current of the ELECTRON beam incident on the TARGET of an X-RAY TU

32、BE. Usually, the X-RAY TUBE CURRENT is expressed by its mean value in milliamperes (mA) IEC 60601-1-3:2008, 3.85 NOTE See Annex B for further considerations. 3.4 CATHODE EMISSION CHARACTERISTIC dependence of the X-RAY TUBE CURRENT on variables, for example FILAMENT CURRENT, X-RAY TUBE VOLTAGE 3.5 EN

33、VELOPE vacuum-wall of the X-RAY TUBE 3.6 ENVELOPE CURRENT electric current, flowing via a conducting part of an ENVELOPE 3.7 ENVELOPE VOLTAGE potential difference between an X-RAY TUBE-conducting ENVELOPE part and earth 3.8 LOADING in an X-RAY GENERATOR, act of supplying electrical energy to the ANO

34、DE of an X-RAY TUBE IEC 60601-1-3:2008, 3.34 3.9 X-RAY TUBE LOAD electrical energy supplied to an X-RAY TUBE expressed by a combination of values of LOADING FACTORS 3.10 LOADING FACTOR factor influencing by its value the X-RAY TUBE LOAD, for example X-RAY TUBE CURRENT, LOADING TIME, CONTINUOUS ANODE

35、 INPUT POWER, X-RAY TUBE VOLTAGE and PERCENTAGE RIPPLE IEC 60601-1-3:2008, 3.35 3.11 LOADING TIME time determined according to a SPECIFIC method, during which the ANODE INPUT POWER is applied to the X-RAY TUBE IEC 60601-1-3:2008, 3.37 BS EN 60613:201060613 IEC:2010 7 3.12 CYCLE TIME for a series of

36、single LOADINGS: time interval from the beginning of a LOADING to the beginning of the next, identical LOADING for a series of serial LOADINGS: time interval from the beginning of a serial LOADING to the beginning of the next, identical serial LOADING 3.13 ANODE INPUT POWER power applied to the ANOD

37、E of an X-RAY TUBE to produce X-RADIATION 3.14 NOMINAL ANODE INPUT POWER highest constant ANODE INPUT POWER that can be applied for a single X-RAY TUBE LOAD in a SPECIFIC LOADING TIME and under SPECIFIED conditions 3.15 NOMINAL RADIOGRAPHIC ANODE INPUT POWER NOMINAL ANODE INPUT POWER which can be ap

38、plied for a single X-RAY TUBE LOAD with a LOADING TIME of 0,1 s and a CYCLE TIME of 1,0 min, for an indefinite number of cycles NOTE 1 In this application, RADIOSCOPY is not applied. NOTE 2 With this definition mammographic and dental X-ray are included, see A.3.3 in Annex A. 3.16 NOMINAL CT ANODE I

39、NPUT POWER NOMINAL ANODE INPUT POWER which can be applied for a single X-RAY TUBE LOAD with a LOADING TIME of 4 s and a CYCLE TIME of 10 min, for an indefinite number of cycles 3.17 X-RAY TUBE ASSEMBLY INPUT POWER mean power applied to an X-RAY TUBE ASSEMBLY for all purposes before, during and after

40、 LOADING, including power applied to the stator of a rotating ANODE X-RAY TUBE, to the filament and to any other device included in the X-RAY TUBE ASSEMBLY 3.18 NOMINAL CONTINUOUS INPUT POWER SPECIFIED highest X-RAY TUBE ASSEMBLY INPUT POWER, which can be applied to an X-RAY TUBE ASSEMBLY continuous

41、ly 3.19 CONTINUOUS ANODE INPUT POWER SPECIFIED highest ANODE INPUT POWER, which can be applied to the ANODE continuously NOTE 1 CONTINUOUS ANODE INPUT POWER may be determined by subtracting all power other than the ELECTRON beam power, such as filament heating, ANODE drive, from the NOMINAL CONTINUO

42、US INPUT POWER. NOTE 2 If not SPECIFIED otherwise, CONTINUOUS ANODE INPUT POWER is the referenced LOADING FACTOR for determining the LEAKAGE RADIATION. 3.20 CT SCAN POWER INDEX CTSPI characteristic of an X-RAY TUBE ASSEMBLY intended for use in COMPUTED TOMOGRAPHY for a SPECIFIED range of LOADING TIM

43、ES for single LOADINGS, for a given CYCLE TIME, as follows () tt d)(1minmaxmaxmin=ttPttCTSPI BS EN 60613:2010 8 60613 IEC:2010 where tmaxis the upper limit of the LOADING TIME in seconds, tminis the lower limit of the LOADING TIME in seconds, and P(t) is the function representing the SINGLE LOAD RAT

44、ING in kilowatts NOTE The CTSPI represents the effective power for PATIENT throughput in CT scanning. 3.21 NOMINAL CT SCAN POWER INDEX NOMINAL CTSPI CTSPI, calculated for a lower limit of the LOADING TIME of 1 s, an upper of the LOADING TIME of 25 s and a CYCLE TIME of 10 min 3.22 RADIOGRAPHIC RATIN

45、GS for the operation of an X-RAY TUBE, SPECIFIED combinations of conditions and LOADING FACTORS, under which the SPECIFIED limits of loadability of the X-RAY TUBE are attained 3.23 SINGLE LOAD RATING highest permitted X-RAY TUBE LOAD given by a relationship between constant ANODE INPUT POWER and LOA

46、DING TIME for one LOADING under SPECIFIED conditions 3.24 SERIAL LOAD RATING highest permitted X-RAY TUBE LOAD given by the relationship between ANODE INPUT POWER and LOADING TIME for the total of a SPECIFIED series of individual X-RAY TUBE LOADS with SPECIFIED LOADING FACTORS under SPECIFIED condit

47、ions 4 Presentation of the electrical characteristic 4.1 X-RAY TUBE VOLTAGE The X-RAY TUBE VOLTAGE shall be given as the peak value, in kilovolts. 4.2 NOMINAL X-RAY TUBE VOLTAGE The NOMINAL X-RAY TUBE VOLTAGE shall be given as the peak value, in kilovolts. 4.3 X-RAY TUBE CURRENT The X-RAY TUBE CURRE

48、NT shall be given as the average value in milliamperes. 4.4 CATHODE EMISSION CHARACTERISTIC CATHODE EMISSION CHARACTERISTICS are given as a family of curves in which the X-RAY TUBE CURRENT is shown as a function of the FILAMENT CURRENT and, if appropriate, of further characteristics of the CATHODE,

49、each curve corresponding to an X-RAY TUBE VOLTAGE while specifying its waveform, and other factors as appropriate. If appropriate, the relationship between FILAMENT CURRENT and filament voltage shall be indicated and also its dependence on other characteristics of the CATHODE. BS EN 60613:201060613 IEC:2010 9 4.5 ENVELOPE characteristics 4.5.1 ENVELOPE CURRENT If the ENVELOPE CURRENT is to be stated, it shall be given as the percentage value of X-RAY TUBE CURRENT under SPECIFI