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YY/T 0889-2013 English PDF (YYT0889-2013)

YY/T 0889-2013 English PDF (YYT0889-2013)

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YY/T 0889-2013: Intensity-modulated radiation treatment planning system - Functional performance characteristics and test methods

This Standard specifies the terms, definitions, performance requirements and test methods of intensity-modulated radiation treatment planning system. This Standard is applicable to intensity-modulated radiation treatment planning system with a high-energy X-beam dose calculation function (hereinafter referred to as the System). The System is used for designing intensity-modulated radiation treatment plans for patients. If the system has the plan design features of radiotherapy techniques other than intensity-modulated radiation treatment, it shall also comply with the corresponding standards.
YY/T ??0889?€?2013
YY
ICS 11.040.60
C 43
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
Intensity-modulated radiation treatment
planning system ?€? Functional performance
characteristics and test methods
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. State Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and Definitions ... 5
4 Performance Requirements ... 6
5 Test Methods ... 6
Annex A (Normative) Test Cases ... 9
Annex B (Informative) Test Data ... 17
Bibliography ... 18
Foreword
This Standard is drafted according to the rules specified in GB/T 1.1-2009. Please note that some content in the Document may involve patents. The issuing authority of this Document does not undertake the responsibility of identifying these patents.
The Standard was proposed by State Food and Drug Administration.
The Standard shall be under the jurisdiction of National Standardization Technical Committee of Medical Appliances Radiotherapy and Technical Committee of Nuclear Medicine and Radiation Dosimetry Equipment (SAC/TC10/SC3).
Drafting organizations of this Standard. Beijing Institute of Medical Device Testing, Cancer Hospital of Chinese Academy of Medical Sciences, Nuclear Science and Technology Research Institute of Sichuan University, and Beijing Cancer Hospital.
The main drafters of this Standard. Jiao Chunying, Zhang Xin, Dai Jianrong, Li Minghui, Gou Chengjun, and Wu Hao.
Intensity-modulated radiation treatment planning
system ?€? Functional performance characteristics and
test methods
1 Scope
This Standard specifies the terms, definitions, performance requirements and test methods of intensity-modulated radiation treatment planning system.
This Standard is applicable to intensity-modulated radiation treatment planning system with a high-energy X-beam dose calculation function (hereinafter referred to as the System). The System is used for designing intensity-modulated radiation treatment plans for patients.
If the system has the plan design features of radiotherapy techniques other than intensity-modulated radiation treatment, it shall also comply with the corresponding standards.
2 Normative??references
The articles contained in the following documents have become part of this Document when they are quoted herein. For the dated documents so quoted, all the modifications (Including all corrections) or revisions made thereafter shall be applicable to this document.
GB 9706.5 Medical electrical equipment - Part 2-1. Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
GB 15213 Medical electron accelerators - Functional performance characteristics and test methods
GB/T 17857 Medical radiology - Terminology (Equipment for radiotherapy, nuclear medicine and radiation dosimetry)
YY 0637 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
3.6
Organs at risk; OAR
The important normal tissues or organs. Their radiosensitivity (tolerated dose) will significantly affect the design of therapeutic schedule or quantity of prescribed dose. 4 Performance??Requirements
4.1 Point-dose calculation accuracy
Each IMRT specified in Appendix A shall be tested.
a) For the measurement points in the target volume, deviation between dose values calculated by system and actual measured dose shall not exceed ?? 4.5%;
b) For the measurement points in OAR, deviation between dose values calculated by system and actual measured dose shall not exceed ?? 4.7%.
4.2 Dose distribution calculation accuracy
Each IMRT specified in Appendix A shall be tested.
a) Measure the dose distribution of composite field within a plane predetermined by die body. Calculate according to the test method specified in 5.3. The points complying with the requirements of ?? 3% / 3mm shall not be less than 88% of all points being taken into calculation;
b) Measure the dose distribution of each single field within a plane predetermined by die body. Calculate according to the test method specified in 5.3. The points complying with the requirements of ?? 3%/3mm shall not be less than 93% of all points being taken into calculation.
4.3 Dose target of treatment plan
For each IMRT test case specified in Appendix A, DESIGN the treatment plan in accordance with the dose target specified in this Standard; REPORT the actual situations that meet dose target.
Note. Dose target is expressed as certain target volume OAR or the dose radiation that can be accepted by the organs at risk?€?s volume.
5 Test??Methods
5.1 Test conditions
of each test case.
c) Register and contrast the dose distribution obtained from film measurement WITH that calculated by the system. Dose distribution obtained from the film within the measuring plane shall be unified to a dose at certain point measured by ionization chamber. The point shall be an appropriate point in the area of high dose and low gradient. Assess the accuracy of the dose distribution calculation of the system, through analyzing and measuring the percentage - the points within the plane complying with the requirement of ?? 3% / 3mm OF all points being taken into calculation.
d) In the measured plane, the points to participate in the region of interest shall be limited, so as to avoid including low dose region. This object can be reached in two ways. The first is to set a dose threshold to determine the interest area; and it shall be set to 10% of the maximum dose. The second is, if the analysis software only supports to set rectangular interest area, the area is set as 10% of circumscribed rectangle of isodose lines.
e) For any point within measuring area, if the deviation between measuring dose value of such-point and calculated dose value of the system is within ??3%; or within the dose distribution plane of system calculation AND within such circular area of which such-point is the center of the circle, the radius is 3 mm, if there exists a point having the same measuring dose with such-point, then such-point shall be deemed to meet the deviation requirement of ??3%/3 mm. The percentage of points that meet the deviation requirement of ??3%/3 mm OF all points being taken into calculation shall meet the requirements of 4.2 a).
f) Accelerator rack shall be placed at 0??. Each single field of IMRT test cases as specified in Appendix A shall be used for radiation. Film shall be placed at the plane specified by each test case for the purpose of measuring the dose distribution of each single field. The percentage of points meeting the deviation requirement of ??3%/3 mm OF all points being taken into calculation shall be analyzed according to requirements of c)-e). It shall meet the requirements of 4.2 b).
Note. If test requirements can be fully met, other testing tools (e.g. two-dimensional array radiation detector) may also be used for experiment to replace the film. Whether the testing tools can fully meet the requirements of experiment, it shall be determined by all parties who reach an agreement in accordance with the document through research and evaluation. 5.4 Dose target of treatment plan
Treatment plan shall be designed according to the requirements as stated in Appendix A. The conformance of dose target of each IMRT test case shall be checked. Dose target of test cases shall be satisfied as far as possible. Otherwise, the actual test data shall be provided for assessment, so as to determine whether the IMRT plan is acceptable. Annex??A
(Normative)
Test??Cases
A.1 Initial test cases
A.1.1 Purpose
These test cases radiate die body through easily-designed fields. It is mainly used to verify the accuracy of system dose calculation prior to the design of IMRT treatment plan. A.1.2 Test case 1 Front and back opposed portal
It shall be designed in accordance with the following requirements.
a) Design the radiation field plan of front and back opposed portal. The radiation field is 10cm??10cm; dose at isocenter is 200cGy; and die body center shall be placed at isocenter.
b) Ionization chamber shall be used to measure the dose at central point of die body. Ionization chamber readings and conversion coefficient of dose shall be determined for the later test cases, according to the measuring results of ionization chamber. c) Use film to measure the dose distribution in the isocentral plane. Analyze the percentage of points that comply with the requirements of ?? 3% / 3 mm OF the points that are involved in the calculation.
A.1.3 Test case 2 Strip field
It shall be designed in accordance with the following requirements.
a) Design a plan. Use a series of front and back opposed portal for radiation. The width of initial field is 3 cm. Aperture on one side or multi-leaf collimator shall be in 3 cm stepping, until the width of the field reaches 15cm (total 5 strip fields). The dose at strip center is 40cGy - 200cGy. T...

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