EN 60731-2012 en Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationMedical electrical equipment Dosimeters with ionization chambers as used in radiotherapyBS EN 60731:2012National forewordThis British Standard is the UK implementation of EN 6073

2、1:2012. It is identical to IEC 60731:2011. It supersedes BS EN 60731:1997, which will be withdrawn on 14 March 2015.The UK participation in its preparation was entrusted by Technical Committee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry.A list of organizations repre

3、sented on this committee 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 2012Published by BSI Standards Limited 2012 ISBN 978 0 58

4、0 65707 8 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 Strategy Committee on 31 July 2012.Amendments issued since publicationDate Text affectedBRITISH STANDARD

5、BS EN 60731:2012EUROPEAN STANDARD EN 60731 NORME EUROPENNE EUROPISCHE NORM April 2012 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussel

6、s 2012 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60731:2012 E ICS 11.040.50 Supersedes EN 60731:1997 + A1:2002English version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy (IEC 60

7、731:2011) Appareils lectromdicaux - Dosimtres chambres dionisation utiliss en radiothrapie (CEI 60731:2011) Medizinische elektrische Gerte - Dosimeter mit Ionisationskammern zur Anwendung in der Strahlentherapie (IEC 60731:2011) This European Standard was approved by CENELEC on 2012-03-14. CENELEC m

8、embers are 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 applic

9、ation to the CEN-CENELEC Management Centre 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 CEN-CENE

10、LEC Management Centre has the 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

11、, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 60731:2012EN 60731:2012 - 2 - Foreword The text of document 62C/506/FDIS, future edition 3 of IEC 60731, prepared by SC 62C, “Equipment for ra

12、diotherapy, nuclear medicine and radiation dosimetry“, of IEC TC 62, “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60731:2012. The following dates are fixed: latest date by which the document has to be implemented at national

13、level by publication of an identical national standard or by endorsement (dop) 2012-12-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2015-03-14 This document supersedes EN 60731:1997 + A1:2002. EN 60731:2012 includes the following significant

14、 technical changes with respect to EN 60731:1997 + A1:2002: The technical modifications versus EN 60731:1997 + A1:2002 concerns performance requirements of RADIOTHERAPY DOSIMETERS intended for the measurement of ABSORBED DOSE TO WATER or AIR KERMA in heavy ion RADIATION FIELDS and SCANNING-CLASS DOS

15、IMETERS normally used for relative dose distribution measurements with a SCANNING SYSTEM such as an automatic water PHANTOM. 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 iden

16、tifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 60731:2012 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated: IEC 60051

17、-1:1997 NOTE Harmonized as EN 60051-1:1998 (not modified). BS EN 60731:2012- 3 - EN 60731:2012 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this docum

18、ent and are indispensable for its application. 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 b

19、y (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60417 data base 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

20、 60601-1 + corr. March + A11 2006 2010 2011 IEC 60601-1-2 (mod) 2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 2010 IEC 60601-1

21、-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 2008 2010 IEC 60601-2-8 2010 Medical electrical equipment - Part 2-8: Particular requi

22、rements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV EN 60601-2-8 201X1)IEC/TR 60788 2004 Medical electrical equipment - Glossary of defined terms - - IEC 60976 2007 Medical electrical equipment - Medical electron accelerators - Funct

23、ional performance characteristics EN 60976 2007 IEC 61010-1 + corr. May 2010 2011 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements EN 61010-1 2010 IEC 61187 - Electrical and electronic measuring equipment - Documentation EN 61187

24、 - IEC 61267 2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics EN 61267 2006 IEC 61676 2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology EN 61676 2002

25、 ISO/IEC Guide 98-3 2008 Uncertainty of measurement - Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) - - 1)To be published. BS EN 60731:2012EN 60731:2012 - 4 - Publication Year Title EN/HD Year ISO/IEC Guide 99 2007 International vocabulary of metrology - Basic and general

26、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 60731:2012 2 60731 IEC:2011 CONTENTS INTRODUCTION . 8 1 Scope and object 9 1.1 Scope 9 1.2 Object . 9 2 Normative references . 9 3 T

27、erms and definitions . 10 4 General requirements . 22 4.1 BASIC SAFETY and ESSENTIAL PERFORMANCE 22 4.2 Performance requirements 22 4.3 REFERENCE VALUES and STANDARD TEST VALUES 22 4.4 General test conditions and methods . 23 4.4.1 STANDARD TEST CONDITIONS 23 4.4.2 Test of components . 23 4.4.3 RATE

28、D or EFFECTIVE RANGE of dose (or KERMA) rates 23 4.4.4 UNCERTAINTY OF MEASUREMENT . 24 4.4.5 Adjustments during test . 24 4.4.6 Test conditions particular to CHAMBER ASSEMBLIES 24 4.4.7 Test conditions particular to MEASURING ASSEMBLIES. 24 4.4.8 Test conditions particular to STABILITY CHECK DEVICES

29、 25 4.4.9 Use of STABILITY CHECK DEVICES . 25 4.5 Summary tables 25 4.6 Classification of equipment according to LIMITS OF VARIATION . 32 4.6.1 FIELD-CLASS DOSIMETER 32 4.6.2 REFERENCE-CLASS DOSIMETER . 32 4.6.3 SCANNING-CLASS DOSIMETER . 32 5 CHAMBER ASSEMBLY performance requirements . 33 5.1 Gener

30、al . 33 5.2 General performance requirements for (RADIOTHERAPY) IONIZATION CHAMBERS 33 5.2.1 CHAMBER ASSEMBLY LEAKAGE CURRENT without IRRADIATION . 33 5.2.2 Stability . 33 5.2.3 STABILIZATION TIME . 34 5.2.4 Post-irradiation leakage . 34 5.2.5 RATED or EFFECTIVE RANGE of dose rate (continuous radiat

31、ion) . 35 5.2.6 Maximum RATED dose per pulse (pulsed radiation) 36 5.2.7 RATED RANGE of field sizes . 37 5.2.8 STRAY RADIATION 38 5.2.9 Guard/collector insulation 38 5.2.10 Cable microphony 39 5.2.11 Polarity of polarizing voltage effect 39 5.2.12 ELECTROMAGNETIC COMPATIBILITY . 40 5.3 Performance r

32、equirements particular to SHELL CHAMBERS . 40 5.3.1 Dependence on RADIATION QUALITY 40 5.3.2 RATED RANGE of field sizes . 43 5.3.3 Chamber orientation 44 5.4 Performance requirements particular to PARALLEL-PLATE CHAMBERS . 45 BS EN 60731:201260731 IEC:2011 3 5.4.1 Dependence on RADIATION QUALITY 46

33、5.4.2 Chamber orientation 47 5.5 Performance requirements particular to VENTED CHAMBERS 47 5.5.1 Atmospheric pressure change . 48 5.5.2 Temperature 48 5.5.3 Humidity 48 5.6 Performance requirements particular to SEALED CHAMBERS. 49 5.6.1 Atmospheric pressure change . 49 5.6.2 Temperature 49 6 MEASUR

34、ING ASSEMBLY performance requirements 50 6.1 General . 50 6.2 General performance requirements for RADIOTHERAPY DOSIMETERS 50 6.2.1 EFFECTIVE RANGES . 50 6.2.2 RESOLUTION of the display or data output terminal . 51 6.2.3 Repeatability . 51 6.2.4 Long-term stability . 51 6.2.5 STABILIZATION TIME . 52

35、 6.2.6 ELECTROMAGNETIC COMPATIBILITY . 52 6.3 Performance requirements particular to dosimeters . 53 6.3.1 ZERO DRIFT 53 6.3.2 ZERO SHIFT . 54 6.3.3 NON-LINEARITY . 55 6.3.4 Range changing 56 6.3.5 Dead time 57 6.3.6 Temperature 57 6.3.7 Humidity 57 6.3.8 STRAY RADIATION effect 58 6.3.9 Charge leaka

36、ge . 58 6.3.10 Dose rate dependence of dosimeters . 59 6.4 Performance requirements particular to dose rate meters 60 6.4.1 ZERO DRIFT 60 6.4.2 ZERO SHIFT . 61 6.4.3 NON-LINEARITY . 61 6.4.4 Range changing 62 6.4.5 RESPONSE TIME 64 6.4.6 Temperature 65 6.4.7 Humidity 65 6.4.8 STRAY RADIATION effect

37、66 6.5 Performance requirements particular to battery-operated MEASURING ASSEMBLIES 66 6.6 Performance requirements particular to supply mains-operated MEASURING ASSEMBLIES 67 6.6.1 MAINS VOLTAGE static 67 6.6.2 MAINS VOLTAGE VARIATION during a measurement 67 7 STABILITY CHECK DEVICE performance req

38、uirements . 68 7.1 General . 68 7.2 General performance requirements for STABILITY CHECK DEVICES 68 7.2.1 Long-term stability . 68 7.2.2 Repeatability . 68 BS EN 60731:2012 4 60731 IEC:2011 8 Constructional requirements as related to PERFORMANCE CHARACTERISTICS . 69 8.1 Constructional requirements o

39、n CHAMBER ASSEMBLIES 69 8.2 Constructional requirements on MEASURING ASSEMBLIES . 69 8.2.1 Adjustment of RESPONSE 69 8.2.2 Display device . 69 8.2.3 Battery indication and compensation . 70 8.2.4 Input current threshold 70 8.2.5 Automatic termination of measurement in the dose mode 70 8.3 Constructi

40、onal requirements on STABILITY CHECK DEVICES 70 8.3.1 Output of the STABILITY CHECK DEVICES . 70 8.3.2 Constructional requirements particular to a radioactive type STABILITY CHECK DEVICE . 71 8.3.3 Constructional requirements particular to an overall STABILITY CHECK DEVICE . 71 8.4 Constructional re

41、quirements on PHANTOMS and build-up caps 71 9 Marking 72 9.1 Marking required on CHAMBER ASSEMBLY 72 9.1.1 Information required in IEC 60601-1 72 9.1.2 Other information . 73 9.1.3 Compliance check . 73 9.2 Marking required on MEASURING ASSEMBLY . 73 9.2.1 CHAMBER ASSEMBLY in contact with the PATIEN

42、T 73 9.2.2 CHAMBER ASSEMBLY not in contact with the PATIENT 73 9.2.3 Each MEASURING ASSEMBLY 73 9.2.4 MEASURING ASSEMBLY with a display scaled in dose . 74 9.2.5 Multi-range MEASURING ASSEMBLY . 74 9.2.6 MEASURING ASSEMBLY with more than one chamber 74 9.2.7 Graphical symbols . 74 9.2.8 Compliance c

43、heck . 74 9.3 Marking required on STABILITY CHECK DEVICE 74 9.3.1 General . 74 9.3.2 STABILITY CHECK DEVICE containing a RADIOACTIVE SOURCE . 74 9.3.3 Device which contributes to protection against IONIZING RADIATION . 74 9.3.4 Compliance check . 74 9.4 Marking required on PHANTOM or build-up cap 75

44、 10 ACCOMPANYING DOCUMENTS . 75 10.1 ACCOMPANYING DOCUMENTS for CHAMBER ASSEMBLY 75 10.1.1 INSTRUCTIONS FOR USE of CHAMBER ASSEMBLY . 75 10.1.2 Test sheet for CHAMBER ASSEMBLY 77 10.1.3 Calibration certificate for CHAMBER ASSEMBLY . 77 10.2 ACCOMPANYING DOCUMENTS for MEASURING ASSEMBLY . 78 10.2.1 I

45、NSTRUCTIONS FOR USE of MEASURING ASSEMBLY 78 10.2.2 Test sheet for MEASURING ASSEMBLY . 80 10.2.3 Calibration certificate for MEASURING ASSEMBLY 80 10.3 ACCOMPANYING DOCUMENTS for STABILITY CHECK DEVICE 81 10.3.1 INSTRUCTIONS FOR USE of STABILITY CHECK DEVICE . 81 10.3.2 Test sheet for STABILITY CHE

46、CK DEVICE 81 10.3.3 Measurement certificate for STABILITY CHECK DEVICE . 81 10.4 ACCOMPANYING DOCUMENTS for PHANTOMS and build-up caps 82 BS EN 60731:201260731 IEC:2011 5 Annex A (informative) Values, error and UNCERTAINTY 84 Annex B (normative) Test equipment for cable microphony 85 Annex C (normat

47、ive) UNCERTAINTY OF MEASUREMENT 86 Bibliography 95 Index of defined terms used in this standard . 96 Figure 1 Tolerance of depth in PHANTOM. 72 Figure 2 Tolerance of lateral position in PHANTOM 72 Figure A.1 Graphical illustration of values, error and UNCERTAINTY . 84 Figure B.1 Test equipment for c

48、able microphony 85 Figure C.1 PROBABILITY DISTRIBUTIONS for the PERFORMANCE CHARACTERISTICS to be within the LIMITS OF VARIATION L and the expression of their VARIANCES in terms of L . 88 Table 1 REFERENCE CONDITIONS and STANDARD TEST CONDITIONS CHAMBER ASSEMBLY . 26 Table 2 REFERENCE CONDITIONS and

49、 STANDARD TEST CONDITIONS MEASURING ASSEMBLY 27 Table 3 Limits of PERFORMANCE CHARACTERISTICS at STANDARD TEST CONDITIONS CHAMBER ASSEMBLY . 27 Table 4 Limits of PERFORMANCE CHARACTERISTICS at STANDARD TEST CONDITIONS MEASURING ASSEMBLY 28 Table 5 LIMITS OF VARIATION of PERFORMANCE CHARACTERISTICS for effects of INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS CHAMBER ASSEMBLY . 29 Table 6 LIMITS OF VARIATION of PERFORMANCE CHARACTERISTICS for effects of INFLUENCE QUANTITIES and INSTRUMENT PARAMETER