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GB 15213-2016 English PDF

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GB 15213-2016: Medical electron accelerators -- Functional performance characteristics and test methods
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GB 15213: Historical versions

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GB 15213-20161859 Add to Cart 13 days Medical electron accelerators -- Functional performance characteristics and test methods Valid
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Basic data

Standard ID: GB 15213-2016 (GB15213-2016)
Description (Translated English): Medical electron accelerators -- Functional performance characteristics and test methods
Sector / Industry: National Standard
Classification of Chinese Standard: F91
Classification of International Standard: 11.040.50
Word Count Estimation: 93,917
Date of Issue: 2016-06-14
Date of Implementation: 2018-01-01
Older Standard (superseded by this standard): GB 15213-1994
Regulation (derived from): National Standard Announcement No. 8 of 2016
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China

GB 15213-2016: Medical electron accelerators -- Functional performance characteristics and test methods


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical electron accelerators - Functional performance characteristics and test methods ICS 11.040.50 F91 National Standards of People's Republic of China Replacing GB 15213-1994 Medical Electron Accelerator and test methods (IEC 60976.2007, NEQ) Issued on.2016-06-14 2018-01-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Preface Ⅶ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 4 environmental conditions 4.1 General requirements 4 4.2 Transportation and storage 4 4.3 Power supply 5 5 Requirements 5 5.1 Dose Monitoring System 5 5.1.1 General requirements 5 5.1.2 Repeatability 5 5.1.3 Linear 5 5.1.4 with the device the angular position variation of 6 5.1.5 The relationship between the rotation of the rack 6 5.1.6 with the radiation field shape variation of 6 5.1.7 stability measured 6 5.1.8 Stability moving beam therapy 7 5.2 depth of the absorbed dose characteristics 8 5.2.1 X radiation 8 5.2.2 electron radiation 8 Uniformity of the radiation field of 5.3 9 5.3.1 X radiation 9 5.3.2 electron irradiation 11 5.3.3 radiation field penumbra 12 5.4 indicates radiation field of 13 5.4.1 X radiation 13 5.4.2 Electronic radiation 16 Geometry and velocity 5.4.3 X radiation and electron radiation adjustable beam limiting system 17 5.4.4 light field illumination and contrast 17 5.5 indicates the radiation beam axis 18 5.5.1 General requirements 18 5.5.2 indicates the radiation beam incident on the surface of the shaft 18 of the patient 5.5.3 radiation beam axis in patients with an indication of the exit surface 18 5.6 isocenter 19 5.6.1 offset the radiation beam axis relative to isocenter 19 5.6.2 indication of such centers 19 5.7 along radiation beam axis distance indicator 19 5.7.1 indicating device 19 Additional equipment and non-indicating device 20 such centers 5.7.2 equipment and other radiation source to the center distance variable 5.8 rotary motion scale zero-scale position 20 5.8.1 General requirements 20 20 5.8.2 Requirements for random files 5.8.3 Performance Indicators 20 5.9 before and after the radiation field coincidence of 20 20 5.9.1 Requirements for random files 5.9.2 Performance Indicators 21 5.10 movement of the couch 21 5.10.1 General requirements 21 5.10.2 vertical movement of the couch 21 5.10.3 couch like the center of rotation 21 5.10.4 couch rotation axis parallel 21 5.10.5 couch stiffness 22 5.11 electronic imaging device (such as EPID) 22 5.11.1 General requirements 22 Mechanical Specifications 5.11.2 support structure 23 5.11.3 Specifications Imaging 23 5.12 random file 25 5.12.1 Performance 25 The nominal energy and absorbed dose rate can be used 5.12.2 25 5.12.3 radiation field can be used 25 5.12.4 Normal treatment distance 25 5.12.5 wedge X radiation field can be used 25 5.12.6 usable flattening filter 25 5.12.7 Preparation time 25 5.12.8 affect the amount of 26 5.12.9 Maintenance 26 5.12.10 given performance index value of 26 5.12.11 radiation beam limiter in the head and internal radiation to the head and other central region of the device size and spacing 26 5.12.12 IMRT 26 6 Test methods 26 Standard Test Conditions 26 6.1 6.1.1 General Description 26 6.1.2 angular position 26 6.1.3 Materials and position of the phantom 27 6.1.4 Test points position 27 6.1.5 radiation detector 27 6.1.6 Standard test depth 27 6.1.7 radiation field 27 28 6.1.8 Adjustment during the test 6.1.9 X-ray photographic film or alternative imaging methods 28 6.2 Dose Monitoring System 28 6.2.1 General requirements 28 6.2.2 Repeatability 28 6.2.3 Linear 28 6.2.4 changing with the angular position of the device 29 6.2.5 The relationship between the rotation of the rack 30 6.2.6 radiation field changes with the shape of the relationship 31 6.2.7 Stability of measurement 31 6.2.8 Stability moving beam therapy 32 6.3 Characteristics of 33 depth absorbed dose 6.3.1 X radiation 33 6.3.2 electron irradiation 34 Uniformity of the radiation field of 35 6.4 6.4.1 X radiation 35 6.4.2 electron irradiation 39 6.4.3 radiation field penumbra 40 6.5 radiation field indication 41 6.5.1 X radiation 41 6.5.2 electron irradiation 44 Geometry and velocity 6.5.3 X radiation and electron radiation adjustable beam limiting system 45 6.5.4 light field illumination and contrast 45 6.6 indicates the radiation beam axis 45 6.6.1 General requirements 45 In patients with an indication of the surface incident radiation beam axis 46 6.6.2 6.6.3 radiation beam axis in patients with an indication of the exit surface 47 6.7 isocenter 47 6.7.1 offset the radiation beam axis relative to isocenter 47 6.7.2 indication of such centers 48 6.8 along radiation beam axis distance indicator 49 6.8.1 indicating device 49 Additional indicating device 6.8.2 radiation source to the variable center distance and other equipment and non-equipment centers, etc. 49 6.9 rotary motion scale zero-scale position 49 6.9.1 General requirements 49 Requirements 6.9.2 49 random files 6.9.3 Performance Indicators 50 6.10 before and after the radiation field coincidence of 50 6.10.1 random documentation requirements 50 6.10.2 Performance 51 6.11 movement of the couch 51 6.11.1 General requirements 51 6.11.2 vertical movement of the couch 51 6.11.3 treatment centers and other rotating bed 52 6.11.4 couch rotation axis parallel 52 6.11.5 couch stiffness 52 6.12 electronic imaging device (e.g. EPID) 54 6.12.1 Overview 54 6.12.2 imaging device characteristic test 54 6.12.3 image quality stability test 54 6.13 random file 54 Appendix A (informative) This standard reg number and IEC 60976.2007 reg number table 68 Referring format Annex B (informative) performance values given 71 Index 84 FIG. 1 is defined wedge filter angle 55 Figure 2 rotary rack 56 Rack Figure 3 is mounted on a wall or floor 57 4 rack 58 is mounted on the ceiling Figure Reeling area within the radiation field 5 (shaded area) 59 Absorbed dose Figure 6 along the main axis or diagonal curve legend 60 7 electronic radiation field flattening degree Description 61 The best layout in the Figure 8 5.6 measurement center 62 9 6.5.1.1.3 Test 63 FIG. 10 is head of radiation X-radiation beam limiting device and accessories (see 5.12.10) 64 FIG. 11 is used to measure the radiation field of X-radiation penumbra multi beam limiting device (see 5.3.3) 65 12 phantom position 66 13 linear dose monitoring system 67 Table 1 Repeatability test condition 28 Table 2 Dose Monitoring system linearity test conditions 29 Test conditions Table 3 Dose Monitoring System with the changes in the relationship between the position of the device 30 Table 4 Test conditions dose monitoring system randomly changes the relationship between the rotation frame 31 Test conditions Table 5 dose monitoring system change relations with the shape of the radiation field 31 Table 6 dose monitoring system measures the stability of test conditions 32 Table 7 dose monitoring system in the test conditions of stability moving beam therapy 33 Table 8 X depth dose radiation characteristic test conditions 34 Table 9 electron depth dose radiation characteristic test conditions 34 Table 10 Test conditions Electronic Stability penetrating radiation 35 Tables are whole region shown in Fig. 11 536 Table 12 X radiation field flatness and symmetry are the test conditions 36 Table 13 square field X-radiation dose distribution varies with the angular position of the test conditions 37 Table 14 radiation field than in the largest absorber test conditions 37 Table 15 Test conditions for the wedge factor 38 Table 16 wedge angle of 38 test conditions Table 17 electronic radiation field are flatness, symmetry, changes in dose distribution with the angular position and the maximum absorbent than the test conditions 39 Table 18 Film scaling conditions 42 Table 19 indicates the digital field and light field test conditions indicated 42 Table 20 X radiation field repeatability of test conditions 43 Table 21 electronic radiation field indicator test conditions 44 Table 22 Test conditions beam limiter system 45 geometry Table 23 indicates the axis of the radiation beam incident surface of the patient's test conditions 46 Table 24 patients out of the radiation beam axis indicates the exit surface of the test conditions 47 Table 25 Test conditions such centers indicated 48 Test conditions vertical movement of the couch 26 Table 51 Test conditions Table 27 treatment centers and other rotating bed 52 Table 28 Test conditions couch rotation axis parallel 53 Table 29 couch lateral stiffness test conditions 53 Table A.1 This standard reg number and IEC 60976.2007 reg number table 68

Foreword

All the technical contents of this standard is mandatory. This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard replaces GB 15213-1994 "Medical Electron Accelerator and test methods", compared with GB 15213-1994 main technical Surgery changes are as follows. a) an increase in Chapter 3 Terms and definitions; b) environmental conditions separately as Chapter 4; c) Chapter 5 adds random documentation requirements; d) Chapters 5 and 6 increased performance and test methods for the following new technologies. --- Dynamic beam transmission technology, for example. ● moving beam radiotherapy; ● Intensity Modulated Radiation Therapy (IMRT); ● Image-Guided Radiation Therapy (IGRT); ● Programmable wedge field (PWF); --- Stereotactic radiotherapy (SRT)/Stereotactic Surgery (SRS); --- Electronic imaging device; --- Multiple beam limiting device. The standard reference method using redrafted IEC 60976.2007 "Medical electrical equipment - Medical electron accelerators Performance" preparation, and IEC 60976.2007 is not equivalent degree of consistency. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Technical Committee of Standardization for medical electrical equipment for radiotherapy, nuclear medicine science equipment at the Technical Committee and the radiation dose (SAC/TC10/SC3) centralized. This standard was drafted. Beijing Medical Device Testing. The main drafters of this standard. Coke spring camp, chapter trillion Park. This standard replaces the standards previously issued as follows. --- GB 15213-1994. Medical Electron Accelerator and test methods

1 Scope

This standard specifies test methods and performance of medical electron accelerators. This standard applies to medical cause for therapeutic purposes of medical electron accelerators. This standard applies to produce X-radiation and electron radiation medical electron accelerators, which has a nominal energy 1MeV ~ 50MeV, at a distance In between 50cm ~ 200cm maximum radiation absorbed dose rate at 1m 0.001Gy/s ~ 1Gy/s, normal treatment distance. This standard applies to other central rack equipped with medical electron accelerators, performance and test methods for non-center equipment, etc. it can be used as appropriate When the amendment.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB 9706.5-2008 Medical electrical equipment - Part 2. 1MeV to 50MeV energy safety of electron accelerators to Seek (IEC 60601-2-1.1998, IDT) GB/T 17006.1-2000 medical imaging departments - Evaluation and routine testing - Part 1. General (IEC 61223-1.1993, IDT) GB/T 17857-1999 Medical imaging academic language (radiotherapy, nuclear medicine and radiation dosimetry equipment) GB/T 18987-2003 Radiotherapy equipment Coordinates, movements and scales (IEC 61217.1996, IDT) GB/T 20012-2005 Medical electrical equipment dose area product meter (IEC 60580.2003, IDT)

3 Terms and Definitions

GB/T 20012-2005, GB 9706.1-2007, GB 9706.5-2008, GB/T 17857-1999, GB/T 17006.1- 2000 as defined in the following terms and definitions apply to this document. 3.1 Reference depth basedepth Phantom plane radiation beam axis maximum absorbed dose of 90% point (distal) where the depth. 3.2 Beam limiting means beamlimitingdevice (BLD) Radiation therapy for blocking or structural collimated ionizing radiation (fixed or mobile), within the treatment area to shield unwanted radiation X Radio or electron radiation. 3.3 The maximum dose depth depthofdosemaximum Phantom surface at a specific distance, the depth of the beam axis at the maximum absorbed dose of radiation within the phantom. 3.4 Dynamic Range dynamicrange Radiation therapy, the dynamic range with a maximum useful signal divided by the minimum useful signal indicates (rms noise). NOTE. The dynamic range is expressed in decibels (dB). 3.5 Electronic imaging apparatus electronicimagingdevice (EID) By one or more radiation detectors and associated electronic components, in order to make digital images of radiation in the form of the patient's anatomy Observation equipment on the viewing screen. NOTE. See 3.6. 3.6 Electronic portal imaging device electronicportalimagingdevice (EPID) It consists of a two-dimensional radiation detector and associated electronic components, placed perpendicular to the axis of the radiation beam to medical electron accelerator radiation beam As a radiation source, allows observation of the patient's anatomy device in the form of a digital radiation image is carried out on a viewing screen. Note. electronic portal imaging device main function is to use an alternative method of imaging film to verify patient positioning. 3.7 Geometric field size geometricalfieldsize From the center of the front surface of the radiation source, the geometric projection beam limiting device at the end of the radiation beam axis is perpendicular to the plane. Note. The shape of the radiation field and the beam limiting device is the same, you can define the geometric field size from the virtual source at any distance. 3.8 IGRT image-guidedradiotherapy (IGRT) One kind of radiation treatment. In the treatment of the acquisition target and its image surrounding anatomical structures to determine patient treatment beam with respect to Predetermined target position to a predetermined position of the beam relative to the target to make the necessary corrections. 3.9 IMRT intensity-modulatedradiationtherapy (IMRT) In general, predetermined by the treatment plan, continuous or discrete manner, the regulation of the electron beam or photon fluence, relative to the patient's Beam treatment direction and the radiation field size. NOTE. The main role of IMRT is to raise the degree of conformal dose distribution with the planned target volume, while the dose of the surrounding normal tissue is minimized. 3.10 isocentric isocenter In the case of the use of such centers. 3.11 Other central equipment isocentricequipment Designed and manufactured to have radiation therapy equipment such centers form. 3.12 Isocentric treatment isocentrictreatment Radiation therapy, the patient's target placed in the center of treatment methods. 3.13 Nominal energy nominalenergy Given by the manufacturer, used to characterize the energy of the radiation beam. 3.14 Normal treatment distance normaltreatmentdistance (NTD) Electron radiation, electron radiation from the windowsill to the radiation beam axis beam limiter terminal or predetermined plane measured distance; When X-radiation, from the front surface of the target along the axis of the radiation beam to the center of the measured distance and so on; for non-isocentric equipment, compared to a predetermined level Surface distance. 3.15 Penetrating penetrativequality When electron irradiation as a phantom surface located a predetermined distance at a predetermined radiation field, the radiation beam from the phantom surface of the distal end of the shaft 80% The maximum dose depth to the distance from the incident surface of the phantom. When X-radiation, the phantom surface located a predetermined distance at a predetermined radiation field, 50% of the radiation beam from the axis of the distal end surface of the phantom Large doses of depth to the distance from the incident surface of the phantom. 3.16 The actual range practicalrange Electron radiation therapy phantom surface in the normal distance, the depth dose curve phantom along radiation beam axis, the steepest decline in segment cut Line extrapolation line with the end of the absorption curve depth dose extrapolation lines intersect, the intersection of the premises is the actual depth of the corresponding range. 3.17 Main - dose monitoring system for primary-secondarydosemonitoringsystem A combination of two dose monitoring system, in this combination, as a primary dose monitoring system, as Another dose monitoring system. 3.18 Programmable wedge wild programmablewedgefield (PWF) Using X radiation beam with or without fixed metal wedge filter, wedge-shaped dose curve formed by controlling the radiation intensity and shift Movable beam limiting relationship between devices can generate programmable wedge-shaped dose curve. 3.19 Quality Index qualityindex X radiation, 20cm and 10cm depth than the depth of the premises of the absorbed dose measurement. Note. the detector is located at the normal treatment distance of 10cm × 10cm radiation field within the phantom along the axis of the radiation beam is measured. 3.20 The type of radiation radiationtype Nature constitute radiation waves or particles, such as. radiation X-radiation or electron radiation. 3.21 Redundant dose monitoring system redundantdosemonitoringsystem A combination of two dose monitoring system, in this combination, two dose monitoring system can be used as the main dose monitoring system. 3.22 The relative surface dose relativesurfacedose Phantom surface located at a position a certain distance when the phantom measured along the axis of the beam of radiation absorbed dose at a depth of 0.5mm and The maximum absorbed dose of radiation beam axle ratio. NOTE. Modify the GB 9706.5-2008 defined 2.1.116. 3.23 SNR signal-noiseratio Radiation therapy, for a uniform input flux, ratio of mean and standard deviation of the image signal from the pixel. Note. The signal to noise ratio is generally expressed as a percentage or in decibels. 3.24 Standard test depth standardmeasurementdepth When measuring ionizing radiation characteristic, predetermined depth within the phantom. 3.25 Stereotactic frame stereotacticframeofreference Three-dimensional coordinate system having a digital indication, for determining the position of the patient anatomical region SRS/SRT of treatment. 3.26 Stereotactic radiosurgery stereotacticradiosurgery (SRS) Specific ways stereotactic radiotherapy, the combined use of a stereotactic frame and anatomical landmarks, given high doses of a single target radiation. 3.27 Stereo......
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