EN 61674-2013 en Medical electrical equipment - Dosimeters with ionization chambers and or semiconductor detectors as used in X-ray diagnostic imaging.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipment Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imagingBS EN 61674:2013National forewordThis British S

2、tandard is the UK implementation of EN 61674:2013. It is identical to IEC 61674:2013. It supersedes BS EN 61674:1998, which will bewithdrawn on 3 January 2016.The UK participation in its preparation was entrusted by Technical CommitteeCH/62, Electrical Equipment in Medical Practice, to Subcommittee

3、CH/62/3,Equipment for radiotherapy, nuclear medicine and radiation dosimetry.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

4、application. The British Standards Institution 2013.Published by BSI Standards Limited 2013 ISBN 978 0 580 70786 5 ICS 11.040.50; 17.240Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and

5、 Strategy Committee on 30 April 2013.Amendments issued since publicationDate Text affectedBRITISH STANDARDBS EN 61674:2013EUROPEAN STANDARD EN 61674 NORME EUROPENNE EUROPISCHE NORM February 2013 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotec

6、hnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61674:2013 E ICS 11.040.50 Supersedes EN 61674:1997 + A1:2002 Engl

7、ish version Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging (IEC 61674:2012) Appareils lectromdicaux - Dosimtres chambres dionisation et/ou dtecteurs semi-conducteurs utiliss en imagerie de diagnostic rayonnement X

8、 (CEI 61674:2012) Medizinische elektrische Gerte - Dosimeter mit Ionisationskammern und/oder Halbleiterdetektoren fr den Einsatz an diagnostischen Rntgeneinrichtungen (IEC 61674:2012) This European Standard was approved by CENELEC on 2013-01-03. CENELEC members are bound to comply with the CEN/CENEL

9、EC 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 the CEN-CENELEC Management Centre or

10、 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 CEN-CENELEC Management Centre has the same status as

11、the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxe

12、mbourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 61674:2013EN 61674:2013 - 2 - Foreword The text of document 62C/551/FDIS, future edition 2 of IEC 61674, prepared by IEC TC 62 “Electrical equipment

13、 in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61674:2013. 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) 2013-10-03

14、latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2016-01-03 This document supersedes EN 61674:1997 + A1:2002. 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 s

15、hall not be held responsible for identifying any or all such patent rights. 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 notes, examples and references: in s

16、maller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF EN 60601-1, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. 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

17、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 requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a perm

18、issible way to achieve compliance with a requirement or test. Endorsement notice The text of the International Standard IEC 61674:2012 was approved by CENELEC as a European Standard without any modification. BS EN 61674:2013- 3 - EN 61674:2013 Annex ZA (normative) Normative references to internation

19、al publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the

20、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 60050 Series International Electrotechnical Vocabulary - - IEC 60417 Data-ba

21、se Graphical symbols for use on equipment - - IEC 60601-1 + corr. December + corr. December 2005 2006 2007 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 + corr. March + A11 2006 2010 2011 IEC 60601-1-3 2008 Medical electrical equipm

22、ent - 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 2008 2010 IEC 60731 2011 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy EN

23、60731 2012 IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 61000-4 Series Electromagnetic compatibility (EMC) - Part 4: Testing and measurement techniques EN 61000-4 Series IEC 61000-4-2 - Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement tech

24、niques - Electrostatic discharge immunity test EN 61000-4-2 - IEC 61000-4-3 - Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test EN 61000-4-3 - IEC 61000-4-4 - Electromagnetic compatibility (EMC) - Part

25、4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test EN 61000-4-4 - IEC 61000-4-6 - Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields EN 61000-4-6 - BS EN 61674

26、:2013EN 61674:2013 - 4 - IEC 61000-4-11 - Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests EN 61000-4-11 - IEC 61187 - Electrical and electronic measuring equipment - Documentation EN 61187 -

27、 IEC 61267 2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics EN 61267 2006 ISO/IEC Guide 98-3 2008 Uncertainty of measurement - Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) - - ISO/IEC Guide 99 2007 Internationa

28、l vocabulary of metrology - Basic and general concepts and associated terms (VIM) - - ISO 3534-1 2006 Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability - - BS EN 61674:2013 2 61674 IEC:2012 CONTENTS INTRODUCTION . 6 1 Scope and object 7 1.1 Scope 7

29、 1.2 Object . 7 2 Normative references . 7 3 Terms and definitions . 8 4 General requirements . 15 4.1 Performance requirements 15 4.2 REFERENCE VALUES and STANDARD TEST VALUES 15 4.3 General test conditions 16 4.3.1 STANDARD TEST CONDITIONS 16 4.3.2 Statistical fluctuations 17 4.3.3 STABILIZATION T

30、IME . 17 4.3.4 Adjustments during test . 17 4.3.5 Batteries 17 4.4 Constructional requirements as related to performance . 18 4.4.1 Components 18 4.4.2 Display 18 4.4.3 Indication of battery condition 18 4.4.4 Indication of polarizing voltage failure 18 4.4.5 Over-ranging . 18 4.4.6 MEASURING ASSEMB

31、LIES with multiple DETECTOR ASSEMBLIES . 19 4.4.7 Radioactive STABILITY CHECK DEVICE . 19 4.5 UNCERTAINTY of measurement . 20 5 Limits of PERFORMANCE CHARACTERISTICS 20 5.1 Linearity 20 5.2 Repeatability . 20 5.2.1 General . 20 5.2.2 Repeatability in the ATTENUATED BEAM 20 5.2.3 Repeatability in the

32、 UNATTENUATED BEAM 21 5.3 RESOLUTION of reading 21 5.4 STABILIZATION TIME . 21 5.5 Effect of pulsed radiation on AIR KERMA and AIR KERMA LENGTH PRODUCT measurements . 22 5.6 Reset on AIR KERMA and AIR KERMA LENGTH PRODUCT ranges 22 5.7 Effects of LEAKAGE CURRENT . 22 5.7.1 AIR KERMA RATE measurement

33、s 22 5.7.2 AIR KERMA and AIR KERMA LENGTH PRODUCT measurements . 22 5.8 Stability . 23 5.8.1 Long term stability . 23 5.8.2 Accumulated dose stability 23 5.9 Measurements with a radioactive STABILITY CHECK DEVICE 23 6 LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES 24 6.1 General . 24 6.2 En

34、ergy dependence of RESPONSE 24 BS EN 61674:201361674 IEC:2012 3 6.3 AIR KERMA RATE dependence of AIR KERMA and AIR KERMA LENGTH PRODUCT measurements . 25 6.3.1 MEASURING ASSEMBLY . 25 6.3.2 IONIZATION CHAMBER Recombination losses . 26 6.4 Dependence of DETECTOR RESPONSE on angle of incidence of radi

35、ation . 26 6.4.1 Non-CT detectors 26 6.4.2 CT DETECTORS . 26 6.5 Operating voltage 27 6.5.1 Mains-operated DOSIMETERS 27 6.5.2 Battery-operated DOSIMETERS 27 6.5.3 Mains rechargeable, battery-operated DOSIMETERS 27 6.6 Air pressure . 28 6.7 Air pressure EQUILIBRATION TIME of the RADIATION DETECTOR .

36、 28 6.8 Temperature and humidity . 28 6.9 Electromagnetic compatibility 29 6.9.1 ELECTROSTATIC DISCHARGE . 29 6.9.2 Radiated electromagnetic fields . 29 6.9.3 CONDUCTED DISTURBANCES induced by bursts and radio frequencies 30 6.9.4 Voltage dips, short interruptions and voltage VARIATIONS . 30 6.10 Fi

37、eld size . 30 6.11 EFFECTIVE LENGTH and spatial uniformity of RESPONSE of CT DOSIMETERS . 30 7 Marking 31 7.1 DETECTOR ASSEMBLY 31 7.2 MEASURING ASSEMBLY 31 7.3 Radioactive STABILITY CHECK DEVICE . 31 8 ACCOMPANYING DOCUMENTS . 31 Annex A (informative) COMBINED STANDARD UNCERTAINTY for dosimeter per

38、formance 33 Index of defined terms 34 Table 1 REFERENCE and STANDARD TEST CONDITIONS . 16 Table 2 Number of readings required to detect true differences (95 % confidence level) between two sets of instrument readings . 17 Table 3 Maximum values for the COEFFICIENT OF VARIATION, vmax, for measurement

39、s in the attenuated beam . 21 Table 4 Maximum values for the COEFFICIENT OF VARIATION, vmax, for measurements in the unattenuated beam . 21 Table 5 LIMITS OF VARIATION for the effects of INFLUENCE QUANTITIES . 24 Table 6 Climatic conditions 28 Table A.1 Estimation of COMBINED STANDARD UNCERTAINTY fo

40、r dosimeter performance 33 BS EN 61674:2013 6 61674 IEC:2012 INTRODUCTION Diagnostic radiology is the largest contributor to man-made IONIZING RADIATION to which the public is exposed. The reduction in the exposure received by PATIENTS undergoing medical radiological examinations or procedures has t

41、herefore become a central issue in recent years. The PATIENT dose will be minimized when the X-ray producing equipment is correctly adjusted for image quality and radiation output. These adjustments require that the routine measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT and/or AIR KERMA RATE be

42、made accurately. The equipment covered by this standard plays an essential part in achieving the required accuracy. The DOSIMETERS used for adjustment and control measurements must be of satisfactory quality and must therefore fulfil the special requirements laid down in this standard. BS EN 61674:2

43、01361674 IEC:2012 7 MEDICAL ELECTRICAL EQUIPMENT DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING 1 Scope and object 1.1 Scope This International Standard specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIME

44、TERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in RADIOGRAPHY, including mammography, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-radiation with generating potentials not greater than 150 kV. This International Standard

45、is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging. 1.2 Object The object of this standard is: a) to establish requirements for a satisfactory level of performance for DIAGNOSTIC DOSIMETERS, and b) to stan

46、dardize the methods for the determination of compliance with this level of performance. This standard is not concerned with the safety aspects of DOSIMETERS. The DIAGNOSTIC DOSIMETERS covered by this standard are not intended for use in the PATIENT ENVIRONMENT and, therefore, the requirements for el

47、ectrical safety applying to them are contained in IEC 61010-1. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the

48、 latest edition of the referenced document (including any amendments) applies. IEC 60050 (all parts), International Electrotechnical Vocabulary (available at ) IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-3:2008, M

49、edical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral standard: Radiation protection in diagnostic X-ray equipment IEC 60417, Graphical symbols for use on equipment (Available at: IEC 60731:2011, Medical electrical equipment Dosimeters with ionization chambers as used in radiotherapy BS EN 61674:2013 8 61674 IEC:2012 IEC 60788:2004, Medical electrical equipment Glossary of defined terms IEC 61000-4 (all parts) Electroma