1、 IEC 60731 Edition 3.0 2011-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Dosimeters with ionization chambers as used in radiotherapy Appareils lectromdicaux Dosimtres chambres dionisation utiliss en radiothrapie IEC60731:2011 THIS PUBLICATION IS COPYRIGHT PROTECTED Cop
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16、: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60731 Edition 3.0 2011-02 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Dosimeters with ionization chambers as used in radiotherapy Appareils lectromdicaux Dosimtres chambres dionisation utiliss en radiothrapie INTERNATIONAL ELE
17、CTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XD ICS 11.040.50 PRICE CODE CODE PRIX ISBN 978-2-88912-382-7 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60731 IEC:2011 CONTENTS FOREWORD . 6
18、INTRODUCTION . 8 1 Scope and object 9 1.1 Scope 9 1.2 Object . 9 2 Normative references . 9 3 Terms 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 conditi
19、ons and methods . 23 4.4.1 STANDARD TEST CONDITIONS 23 4.4.2 Test of components . 23 4.4.3 RATED 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 par
20、ticular to MEASURING ASSEMBLIES. 24 4.4.8 Test conditions particular to STABILITY CHECK DEVICES 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
21、 4.6.3 SCANNING-CLASS DOSIMETER . 32 5 CHAMBER ASSEMBLY performance requirements . 33 5.1 General . 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
22、.4 Post-irradiation leakage . 34 5.2.5 RATED or EFFECTIVE RANGE of dose rate (continuous radiation) . 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 Polar
23、ity of polarizing voltage effect 39 5.2.12 ELECTROMAGNETIC COMPATIBILITY . 40 5.3 Performance requirements 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
24、-PLATE CHAMBERS . 45 60731 IEC:2011 3 5.4.1 Dependence on RADIATION QUALITY 46 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 CH
25、AMBERS. 49 5.6.1 Atmospheric pressure change . 49 5.6.2 Temperature 49 6 MEASURING 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
26、Repeatability . 51 6.2.4 Long-term stability . 51 6.2.5 STABILIZATION TIME . 52 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 Temp
27、erature 57 6.3.7 Humidity 57 6.3.8 STRAY RADIATION effect 58 6.3.9 Charge leakage . 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 RESPON
28、SE TIME 64 6.4.6 Temperature 65 6.4.7 Humidity 65 6.4.8 STRAY RADIATION effect 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 VOL
29、TAGE VARIATION during a measurement 67 7 STABILITY CHECK DEVICE performance requirements . 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 4 60731 IEC:2011 8 Constructional requirements as related to PERF
30、ORMANCE CHARACTERISTICS . 69 8.1 Constructional requirements on 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
31、 termination of measurement in the dose mode 70 8.3 Constructional 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 t
32、o an overall STABILITY CHECK DEVICE . 71 8.4 Constructional requirements 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 A
33、SSEMBLY . 73 9.2.1 CHAMBER ASSEMBLY in contact with the PATIENT 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
34、one chamber 74 9.2.7 Graphical symbols . 74 9.2.8 Compliance check . 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
35、 check . 74 9.4 Marking required on PHANTOM or build-up cap 75 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
36、.2 ACCOMPANYING DOCUMENTS for MEASURING ASSEMBLY . 78 10.2.1 INSTRUCTIONS 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 S
37、TABILITY CHECK DEVICE . 81 10.3.2 Test sheet for STABILITY CHECK DEVICE 81 10.3.3 Measurement certificate for STABILITY CHECK DEVICE . 81 10.4 ACCOMPANYING DOCUMENTS for PHANTOMS and build-up caps 82 60731 IEC:2011 5 Annex A (informative) Values, error and UNCERTAINTY 84 Annex B (normative) Test equ
38、ipment for cable microphony 85 Annex C (normative) 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 UN
39、CERTAINTY . 84 Figure B.1 Test equipment for cable 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
40、ASSEMBLY . 26 Table 2 REFERENCE CONDITIONS and 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
41、 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 PARAMETERS MEASURING ASSEMBLY 31 Table 7 LIMITS OF VARIATION
42、of PERFORMANCE CHARACTERISTICS for effects of INFLUENCE QUANTITIES and INSTRUMENT PARAMETERS chamber and MEASURING ASSEMBLIES combined . 32 Table C.1 Estimate of COMBINED STANDARD UNCERTAINTY for performance of a hypothetical dosimeter 90 Table C.2 A hypothetical example of the assessment of the UNC
43、ERTAINTIES on the output measurement of an X-ray set using a FIELD-CLASS DOSIMETER . 94 6 60731 IEC:2011 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT DOSIMETERS WITH IONIZATION CHAMBERS AS USED IN RADIOTHERAPY FOREWORD 1) The International Electrotechnical Commission (IEC
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