IEC 60976-2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics《医用电气设备.医用电子加速器.功能特性》.pdf

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1、 IEC 60976Edition 2.0 2007-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Medical electron accelerators Functional performance characteristics Appareils lectromdicaux Acclrateurs mdicaux dlectrons Caractristiques fonctionnelles de performance IEC60976:2007THIS PUBLICATION

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16、nous: Email: csciec.ch Tl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60976Edition 2.0 2007-10INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Medical electron accelerators Functional performance characteristics Appareils lectromdicaux Acclrateurs mdicaux dlectrons Caractrist

17、iques fonctionnelles de performance INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XDICS 11.040.50; 13.280 PRICE CODECODE PRIXISBN 2-8318-9314-3 2 60976 IEC:2007 CONTENTS FOREWORD.6 INTRODUCTION.8 1 Scope.9 2 Normative references .10 3 Terms and definitions .10

18、4 Environmental conditions14 4.1 General .14 4.2 Transport and storage .14 4.3 Power supply.14 5 General information to the USER .14 5.1 Functional performance characteristics .14 5.2 Available nominal energies and ABSORBED DOSE RATES 14 5.3 Available RADIATION FIELDS 15 5.4 NORMAL TREATMENT DISTANC

19、E.15 5.5 Available WEDGE X-RAY FIELDS .15 5.6 Available flattening FILTERS .15 5.7 Availability.16 5.8 Influencing quantities 16 5.9 Maintenance16 5.10 Presentation16 5.11 Dimensions, clearances, within the RADIATION HEAD, and in the region RADIATION HEAD to ISOCENTRE, of BEAM LIMITING DEVICES .16 5

20、.12 IMRT .16 6 Standardized test conditions.17 6.1 General .17 6.2 Angle settings .17 6.3 Properties and positioning of the PHANTOM 17 6.4 Positioning of measuring points.17 6.5 RADIATION DETECTORS 17 6.6 STANDARD MEASUREMENT DEPTHS18 6.7 RADIATION FIELDS .18 6.8 Adjustments during test.18 6.9 Use o

21、f RADIOGRAPHIC FILM or alternative imaging method.18 7 DOSE MONITORING SYSTEM .18 7.1 General .18 7.2 Reproducibility 19 7.3 Proportionality.20 7.4 Dependence on angular positions21 7.5 Dependence on GANTRY rotation22 7.6 Dependence on the shape of the RADIATION FIELD 22 7.7 Stability of calibration

22、 23 7.8 Stability in MOVING BEAM RADIOTHERAPY25 8 Depth ABSORBED DOSE characteristics.26 8.1 X-RADIATION.26 8.2 ELECTRON RADIATION 28 60976 IEC:2007 3 9 Uniformity of RADIATION FIELDS 31 9.1 X-RADIATION.31 9.2 ELECTRON RADIATION 36 9.3 PENUMBRA of RADIATION FIELDS.38 10 Indication of RADIATION FIELD

23、S.39 10.1 X-RADIATION.39 10.2 ELECTRON RADIATION 45 10.3 Geometry and motion speeds of adjustable BLDs for X-RADIATION and ELECTRON RADIATION 46 10.4 Illuminance and PENUMBRA of the LIGHT FIELD.47 11 Indication of the RADIATION BEAM AXIS48 11.1 General .48 11.2 Indication on entry to the PATIENT 49

24、11.3 Indication on exit from the PATIENT 51 12 ISOCENTRE 52 12.1 Displacement of the RADIATION BEAM AXIS from the ISOCENTRE .52 12.2 Indication of the ISOCENTRE .53 13 Indication of distance along the RADIATION BEAM AXIS 53 13.1 Indicating device .53 13.2 Additional indicating device for equipment w

25、ith variable distance between RADIATION SOURCE and ISOCENTRE and for non-isocentric equipment 54 14 Zero position of rotational scales55 14.1 General .55 14.2 Information to the USER .55 14.3 Tests.55 15 Congruence of opposed RADIATION FIELDS.56 15.1 Information to the USER .56 15.2 Test.56 16 Movem

26、ents of the PATIENT table57 16.1 General .57 16.2 Vertical movement of the table 57 16.3 ISOCENTRIC rotation of the table.58 16.4 Parallelism of table rotational axes58 16.5 Rigidity of the table .59 17 ELECTRONIC IMAGING DEVICE (e.g. EPID)60 17.1 Information to the USER .60 17.2 Tests.62 Annex A (i

27、nformative) Format for presentation of functional performances values.75 Index of defined terms 96 Figure 1 Explanatory diagram for the definition of wedge .64 Figure 2 The rotary GANTRY65 Figure 3 The wall- or floor-mounted GANTRY.66 Figure 4 The ceiling-mounted GANTRY 67 Figure 5 Flattened area (s

28、hown hatched) within the RADIATION FIELD 68 4 60976 IEC:2007 Figure 6 Examples of profiles of ABSORBED DOSE along the major axes or the diagonal axes .69 Figure 7 Explanatory diagram for flatness of the ELECTRON FIELD .70 Figure 8 A possible arrangement of equipment for the measurement of the ISOCEN

29、TRE described in Clause 12 .71 Figure 9 Test 10.1.1.372 Figure 10 RADIATION HEAD showing X-RADIATION BLDs and ACCESSORIES (see 4.11) .73 Figure 11 Multi-element BLD RADIATION FIELDS used for measurement of X-RADIATION PENUMBRA (see 8.3.2)74 Table 1 Conditions for testing reproducibility19 Table 2 Co

30、nditions for testing proportionality of the DOSE MONITORING SYSTEM20 Table 3 Conditions for testing dependence of the DOSE MONITORING SYSTEM on equipment position21 Table 4 Conditions for testing dependence of the DOSE MONITORING SYSTEM on GANTRY rotation.22 Table 5 Conditions for testing dependence

31、 on the shape of the RADIATION FIELD.23 Table 6 Conditions for testing stability of calibration of the DOSE MONITORING SYSTEM24 Table 7 Conditions for testing stability of the DOSE MONITORING SYSTEM in MOVING BEAM RADIOTHERAPY 26 Table 8 Conditions for testing depth dose characteristics.27 Table 9 C

32、onditions for testing depth dose characteristics.29 Table 10 Conditions for testing stability of PENETRATIVE QUALITY of ELECTRON RADIATION29 Table 11 Flattened area according to Figure 5 31 Table 12 Conditions for testing flatness and symmetry of X-RAY FIELDS 32 Table 13 Conditions for testing devia

33、tion of dose distribution of X-RAY FIELDS with angular position 33 Table 14 Conditions for testing maximum ABSORBED DOSE ratio in the RADIATION FIELD .34 Table 15 Conditions for testing WEDGE FACTORS .35 Table 16 Conditions for testing WEDGE ANGLES .35 Table 17 Conditions for testing flatness, symme

34、try, deviation of dose distribution with angular position, and maximum ABSORBED DOSE ratio of ELECTRON FIELDS .37 Table 18 Conditions for film calibration 41 Table 19 Conditions for testing the numerical and the LIGHT FIELD-INDICATION.42 Table 20 Conditions for testing reproducibility of X-RAY FIELD

35、S .44 Table 21 Conditions for testing the LIGHT FIELD-INDICATOR for ELECTRON RADIATION 46 Table 22 Conditions for testing geometry of the BEAM LIMITING SYSTEM 48 Table 23 Conditions for testing the indication of the RADIATION BEAM AXIS on entry to the PATIENT .50 Table 24 Conditions for testing the

36、indication of the RADIATION BEAM AXIS on exit from the PATIENT .51 60976 IEC:2007 5 Table 25 Conditions for testing indication of the ISOCENTRE53 Table 26 Conditions for testing vertical movement of the table.58 Table 27 Conditions for testing ISOCENTRIC rotation of the table .58 Table 28 Conditions

37、 for testing the angulation of rotational axes of the table .59 Table 29 Conditions for testing lateral rigidity of the table 60 6 60976 IEC:2007 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT MEDICAL ELECTRON ACCELERATORS FUNCTIONAL PERFORMANCE CHARACTERISTICS FOREWORD 1)

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48、ble for identifying any or all such patent rights. International standard IEC 60976 has been prepared by subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment in medical practice. This second edition cancels and re

49、places the first edition published in 1989. It constitutes a technical revision. This second edition includes the addition of performance standards and test methods relating to the following new technologies: dynamic beam delivery techniques, such as MOVING BEAM RADIOTHERAPY, INTENSITY-MODULATED RADIATION THERAPY (IMRT), IMAGE-GUIDED RADIOT