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YY/T 0889-2013

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YY/T 0889-2013 英文版 750 购买 现货,9秒内自动发货PDF,有增值税发票。 调强放射治疗计划系统 性能和试验方法 有效

   
标准编号: YY/T 0889-2013 (YY/T0889-2013)
中文名称: 调强放射治疗计划系统 性能和试验方法
英文名称: Intensity-modulated radiation treatment planning system - Functional performance characteristics and test methods
行业: 医药行业标准 (推荐)
中标分类: C43
国际标准分类: 11.040.60
字数估计: 16,127
引用标准: GB 9706.5; GB 15213; GB/T 17856; YY 0637
起草单位: 北京市医疗器械检验所
归口单位: 全国医用电器标准化技术委员会放射治疗、核医学和放射剂量学设备标准化分技术委员会
标准依据: 国家食品药品监督管理总局公告2013年第36号;行业标准备案公告2013年第12号(总第168号)
提出机构: 国家食品药品监督管理总局
发布机构: 国家食品药品监督管理总局
范围: 本标准规定了调强放射治疗计划系统的术语、定义、性能要求和试验方法。本标准适用于具有高能X射束剂量计算功能的调强放射治疗计划系统(以下简称系统) 。该系统用于设计患者的调强放射治疗计划。如果系统具有调强放射治疗外其他放射治疗技术的计划设计功能, 还应符合相应的标准。

YY/T 0889-2013
Intensity-modulated radiation treatment planning system - Functional performance characteristics and test methods
ICS 11.040.60
C43
中华人民共和国医药行业标准
调强放射治疗计划系统 性能和试验方法
2013-10-21发布
2014-10-01实施
国家食品药品监督管理总局 发 布
目次
前言 Ⅲ
1 范围 1
2 规范性引用文件 1
3 术语和定义 1
4 性能要求 2
4.1 点剂量计算准确性 2
4.2 剂量分布计算准确性 2
4.3 治疗计划剂量目标 2
5 试验方法 2
5.1 试验条件 2
5.2 点剂量计算准确性 2
5.3 剂量分布计算准确性 3
5.4 治疗计划剂量目标 3
附录A(规范性附录) 测试例 4
附录B(资料性附录) 试验数据 11
参考文献 12
前言
本标准按照GB/T 1.1-2009给出的规则起草。
请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别这些专利的责任。
本标准由国家食品药品监督管理总局提出。
本标准由全国医用电器标准化技术委员会放射治疗、核医学和放射剂量学设备分技术委员会
(SAC/TC10/SC3)归口。
本标准起草单位:北京市医疗器械检验所、中国医学科学院肿瘤医院、四川大学原子核科学技术研
究所、北京肿瘤医院。
本标准主要起草人:焦春营、张新、戴建荣、李明辉、勾成俊、吴昊。
调强放射治疗计划系统 性能和试验方法
1 范围
本标准规定了调强放射治疗计划系统的术语、定义、性能要求和试验方法。
本标准适用于具有高能X射束剂量计算功能的调强放射治疗计划系统(以下简称系统)。该系统
用于设计患者的调强放射治疗计划。
如果系统具有调强放射治疗外其他放射治疗技术的计划设计功能,还应符合相应的标准。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB 9706.5 医用电气设备 第2部分:能量为1MeV至50MeV电子加速器 安全专用要求
GB 15213 医用电子加速器性能和试验方法
GB/T 17857 医用放射学术语(放射治疗、核医学和辐射剂量学设备)
YY0637 医用电气设备 放射治疗计划系统的安全要求
3 术语和定义
GB 9706.5、GB 15213、GB/T 17857、YY0637中界定的以及下列术语和定义适用于本文件。
3.1
调强放射治疗 intensity-modulatedradiationtherapy;IMRT
一种治疗方法,通常采用治疗计划预先确定的连续或离散的方式,调控光子或电子束的注量、相对
于患者的射束方向和射野尺寸。
注:IMRT的主要作用是提高剂量分布对计划靶区的适形度,同时使周围正常组织的剂量最小化。
3.2
靶区 targetvolume
放射治疗中,准备向患者体内辐照一定吸收剂量的区域。
3.3
临床靶区 clinicaltargetvolume;CTV
按一定的时间剂量模式给予一定剂量的肿瘤的临床灶(肿瘤区)、亚临床灶以及肿瘤可能侵犯的
范围。
3.4
计划靶区 planningtargetvolume;PTV
包括CTV本身和由于辐照中患者器官运动、日常摆位、治疗中靶区位置以及靶区体积变化等因素
引起的扩大辐照的组织范围,以确保CTV得到规定的治疗剂量。
3.5
处方剂量 prescriptiondose
按照一定的时间剂量分割方式,给予靶区的治疗剂量。

YY/T 0889‐2013 
YY
ICS 11.040.60
C 43
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Intensity-modulated radiation treatment
planning system — Functional performance
characteristics and test methods
调强放射治疗计划系统性能和试验方法
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.
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;
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.
5.1 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
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
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
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.
(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
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.
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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