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GB/T 19046-2013 English PDF

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GB/T 19046-2013: Medical electron accelerators acceptance and periodic tests
Status: Valid

GB/T 19046: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
GB/T 19046-2013English1079 Add to Cart 7 days [Need to translate] Medical electron accelerators acceptance and periodic tests Valid GB/T 19046-2013
GB/T 19046-2003EnglishRFQ ASK 6 days [Need to translate] Medical electron accelerators acceptance test and periodic tests Obsolete GB/T 19046-2003

Standard similar to GB/T 19046-2013

GB/T 40618   GB/T 39325   GB 15213   

Basic data

Standard ID GB/T 19046-2013 (GB/T19046-2013)
Description (Translated English) Medical electron accelerators acceptance and periodic tests
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard F91
Classification of International Standard 11.040.50
Word Count Estimation 49,484
Older Standard (superseded by this standard) GB/T 19046-2003
Regulation (derived from) National Standards Bulletin No. 25 of 2013
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/T 19046-2013: Medical electron accelerators acceptance and periodic tests

---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 acceptance and periodic tests ICS 11.040.50 F91 National Standards of People's Republic of China Replacing GB/T 19046-2003 Medical electronic accelerator Acceptance test and periodic inspection procedures (IEC /T R60977..2008, NEQ) 2013-12-17 release 2014-08-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People 's Republic of China China National Standardization Management Committee released Directory Preface Ⅴ 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Performance requirements 4.1 dose monitoring system 4.1.1 Repeatability 1 4.1.2 Linearity 2 4.1.3 changes in the angular position of the device 2 4.1.4 Change of the rotation of the frame 2 4.1.5 Day stability 2 4.1.6 stability of mobile beam therapy 2 4.2 depth absorption dose characteristics 2 4.2.1 X-Radiation 2 4.2.2 Electron radiation 2 4.3 uniformity of radiation field 3 4.3.1 X-Radiation 3 4.3.2 Electron radiation 4 4.3.3 Penetration of Radiation Fields 4.4 Indicator of radiation field 4 4.4.1 X-Radiation 4 4.4.2 Adjustability of X-Radiation and Electron Radiation The geometry and velocity of the beam system 6 4.5 Indication of radiation beam axis 6 4.5.1 Position indication of the radiation beam axis on the patient's incident surface 4.5.2 Radial beam axis position indication on patient exit surface 6 4.6 and other centers 6 4.6.1 Radial beam axis offset relative to the center point 6 4.6.2 Indication of the Center 6 4.7 Distance indication along the beam axis 6 4.7.1 indicating device 6 4.7.2 Additional sources for radiation source to equidistant distance variable equipment and non-centering equipment 6 4.8 Rotate the zero scale of the movement scale 7 4.9 coincidence of radiation field before and after 7 4.10 movement of the treatment bed 7 4.10.1 Overview 7 4.10.2 Vertical movement of the treatment bed 7 4.10.3 Equal center rotation of the treatment bed 7 4.10.4 Stiffness of the treatment bed 7 4.11 Electronic imaging device spatial resolution 8 5 Test Method 8 5.1 Standard test conditions 8 5.2 Dosage Monitoring System 5.2.1 Repeatability 8 5.2.2 Linearity 8 5.2.3 Change relationship with the position of the equipment 9 5.2.4 Change of the rotation of the frame 9 5.2.5 Day stability 9 5.2.6 Stability of mobile beam therapy 9 5.3 depth absorption dose characteristics 10 5.3.1 X-Radiation 10 5.3.2 Electron radiation 10 5.4 uniformity of radiation field 5.4.1 X-Radiation 10 5.4.2 Electron radiation 11 5.4.3 Peninsula of the radiation field 5.5 Indicator of radiation field 5.5.1 X-Radiation 12 5.5.2 Adjustability of X-Radiation and Electron Radiation The geometry and velocity of the beam-limited system 12 5.6 position indication of the radiation beam on the incident surface and the exit surface of the patient 5.7 and other centers 13 5.7.1 Offset of the beam axis relative to the isocenter 5.7.2 Indicators of the Center 13 5.8 Distance indication along the beam axis 5.9 Rotate the zero scale of the movement scale 5.9.1 Rack rotation axis ①, Radial head longitudinal axis ③ 14 5.9.2 Radial head transverse rotation shaft ② 14 5.9.3 Rotation axis of the beam system ④ 14 5.9.4 The center of the treatment bed rotation axis ⑤, the bed of the treatment of the rotation axis ⑥ 14 5.9.5 Treatment bed longitudinal rotation axis ⑦, horizontal rotation axis ⑧ 14 5.10 coincidence of radiation field before and after 14 5.11 Exercise of the treatment bed 14 5.11.1 Overview 14 5.11.2 Vertical movement of the treatment bed 15 5.11.3 Equal center rotation of the treatment bed 15 5.11.4 Stiffness of the treatment bed 15 5.12 Electronic imaging device spatial resolution 15 Acceptance test conditions 7 cycle test 20 7.1 Periodic inspection methods and conditions 7.2 Recommended frequency of the cycle test for the electronic accelerator working life

8 Recommended test equipment for acceptance test and cycle inspection

8.1 Description 25 8.2 Device description 26 Appendix A (Normative Appendix) Acceptance Test Item Selection Reference 35 Appendix B (Normative Appendix) Periodic Test Item Selection Reference 37 Appendix C (informative) This standard is in line with IEC /T R60977..2008, GB 15213-2016 Appendix D (informative) The technical differences between this standard and IEC /T R60977..2008 and its causes 41 Figure 1 Definition of the angle of the wedge filter Figure 2 Rotary frame 27 Figure 3 Radiation field within the whole area (shadow area) 28 Figure 4 Absorbance dose curve along the spindle or diagonal Figure 5 shows the uniformity of the electron field Figure 6 5.7 shows the optimal layout of the center of the measurement Figure 7 5.5.1.1 Test 31 Figure 8 Radiation field of the multivariate beam device used to measure X-radiation penumbra (see 4.3.3) Figure 9 Body position 33 Figure 10 Linearity of the dose monitoring system Table 1 Acceptance test conditions Table 2 Cycle test methods and conditions 20 Table 3 Recommended frequency of the cycle test for the electronic accelerator working life Table A.1 Acceptance Test Item Selection Reference 35 Table B.1 Periodic Inspection Item Selection Reference 37 Table C.1 The number of this standard and IEC /T R60977..2008, GB 15213-2016 Article number control 39 Table D.1 Technical differences between this standard and IEC /T R60977..2008 and its causes 41

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces GB/T 19046-2003 "Medical Electron Accelerator Acceptance Test and Periodic Inspection Procedure". This standard compared with GB/T 19046-2003, the main technical changes are as follows. a) Added chapter 3 terms and definitions. b) Chapters 4 and 5 increase the performance and test methods of the following new technologies. Intensive radiation therapy (IMRT); Stereotactic Radiotherapy (SRT)/Stereotactic Surgery (SRS); - electronic imaging device; --- multi-limiting device. c) Chapter 7 adds the "Recommended frequency of periodic inspection of the electronic accelerator working life". Refer to IEC /T R60977..2008 "Guidelines for the Performance of Medical Electron Accelerators for Medical Electrical Equipment" System, and IEC /T R60977..2008 consistency degree is not equivalent. IEC /T R60977..2008 The recommended performance indicators in Chapter 3 have been national standards GB 15213-2016 "Medical Electron Accelerator Performance and test methods "and incorporated into Chapter 5 of the standard. Taking into account the corresponding relationship with the national standard GB 15213-2016, This standard compared with IEC /T R60977..2008, made the following editorial changes. a) modify the name of the standard to show the difference between GB 15213-2016; b) The chapters and choreography of chapters 1 to 5 are basically in accordance with GB 15213-2016; c) Removed some of the contents of IEC /T R60977..2008, Chapter 3, and Chapters 4 and 5. For ease of comparison, the information on this standard is listed in the Appendix C and IEC /T R60977..2008 and GB 15213- 2016 Chapter of the control list. Taking into account the feasibility of the standard, this standard compared with IEC /T R60977..2008, made the following technical changes. a) make appropriate modifications and additions to the technical specifications in Chapter 4 Performance Requirements; b) Removed the "maximum absorbed dose ratio of electron radiation", "Optical field indication of electron radiation field" "Parallelism of the rotation axis of the treatment bed"; c) Added normative Appendix A "Acceptance test project selection reference" and normative Appendix B "Periodical inspection project selection reference"; d) Increased safety requirements for radiation protection. "Spurious X-Radiation in Electron Irradiation" and "Relative Surface Dose in X Irradiation" (see 4.2); e) an illustration of the contents of GB 15213-2016 relating to the contents of this standard. These technical differences are described separately in the Data Appendix D. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Appliances Standardization Technical Committee of Radiation Therapy, Nuclear Medicine and Radiation Dosing Equipment Subcommittee (SAC/TC10/SC3). The drafting of this standard. Beijing Medical Device Testing Institute. The main drafters of this standard. Jiao Chunying, Zhang Zhaoyuan. This standard replaced the previous version of the standard release. --- GB/T 19046-2003. Medical electronic accelerator Acceptance test and periodic inspection procedures

1 Scope

This standard specifies the performance requirements, test methods, test conditions and inspection cycles for medical electronic accelerator acceptance tests and cycle tests. This standard applies to the medical electronic accelerator after the initial installation, the manufacturer, the user and a third party jointly conducted acceptance test, and set In the normal work, the user carries out the periodic inspection. This standard applies to medical care for the purpose of radiation therapy, can produce X-radiation and electron radiation, the nominal energy of 1MeV ~ 50MeV medical electronic accelerator. This standard is applicable to medical electronic accelerators equipped with an isocenter rack, and the performance and test methods of non-center equipment carried out.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB 9706.5-2008 Medical electrical equipment - Part 2. Energy for the 1MeV to 50 MeV electronic accelerator Claim Performance and test methods for medical electronic accelerators GB 15213-2016 Medical Radiology Terminology GB/T 17857

3 terms and definitions

GB 9706.5-2008, GB 15213-2016, GB/T 17857 The terms and definitions defined apply to this document.

4 performance requirements

4.1 dose monitoring system 4.1.1 Repeatability Reproducibility S is characterized by a coefficient of variation, and for X-radiation and electron radiation, under the same irradiation condition, the dose monitoring count and the absorbed dose The coefficient of variation for the ratio of measured values should not be greater than 0.5%. Repeatability S is determined by the coefficient of variation given by equation (1). S = R Σ i = 1 (R-Ri) 2 n-1 × 100% (1) Where. R - the average of the ratio Ri determined by Eq. (2) Ri - the ratio of the dose monitoring count to the absorbed dose measured at the i-th measurement; n - number of measurements.

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