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YY 0831.1-2011

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YY 0831.1-2011 英文版 590 购买 现货,9秒内自动发货PDF,有增值税发票。 γ射束立体定向放射治疗系统 第1部分:头部多源γ射束立体定向放射治疗系统 有效

   
标准编号: YY 0831.1-2011 (YY0831.1-2011)
中文名称: γ射束立体定向放射治疗系统 第1部分:头部多源γ射束立体定向放射治疗系统
英文名称: Stereotactic radiotherapy system with gamma beam - Part 1: Multi-source stereotactic radiotherapy system with gamma beam for head lesion
行业: 医药行业标准
中标分类: C43
国际标准分类: 11.040.50
字数估计: 11,159
发布日期: 2011-12-31
实施日期: 2013-06-01
引用标准: GB 9706.1-2007; GB 9706.15-2008; GB 9706.17-2009; GB/T 17857-1999; GB/T 18987-2003; YY 0637-2012
起草单位: 北京市医疗器械检验所、深圳市海博科技有限公司、玛西普医学科技发展(深圳)有限公司、深圳市圣爱医学科技发展有限公司、深圳市尊瑞科技有限公司
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分技术委员会(SAC/TC 10/SC 3)
标准依据: 国家食品药品监督管理局公告2011年第106号;行业标准备案公告2013年第6号(总第162号)
提出机构: 国家食品药品监督管理局
发布机构: 国家食品药品监督管理局
范围: YY 0831的本部分规定了头部多源γ射束立体定向放射治疗系统的适用范围、术语、定义、要求和试验方法。本部分适用于头部多派γ射束立体定向放射治疗系统(以下简称系统), 该系统同时使用多个60Co密封放射源(可以是运动的, 也可以是静止的)对头部病变区域进行聚束照射。

YY 0831.1-2011
Stereotactic radiotherapy system with gamma beam - Part 1: Multi-source stereotactic radiotherapy system with gamma beam for head lesion
ICS 11.040.50
C43
中华人民共和国医药行业标准
γ射束立体定向放射治疗系统
第1部分:头部多源γ射束立体
定向放射治疗系统
2011-12-31发布
2013-06-01实施
国家食品药品监督管理局 发 布
前言
本部分的全部技术内容为强制性。
YY0831《γ射束立体定向放射治疗系统》分为两个部分:
---第1部分:头部多源γ射束立体定向放射治疗系统;
---第2部分:体部多源γ射束立体定向放射治疗系统。
本部分为YY0831的第1部分。
本部分按照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。
本部分由国家食品药品监督管理局提出。
本部分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。
本部分起草单位:北京市医疗器械检验所、深圳市海博科技有限公司、玛西普医学科技发展(深圳)
有限公司、深圳市圣爱医学科技发展有限公司、深圳市尊瑞科技有限公司。
本部分主要起草人:章兆园、张新、宋连有、陈静、朱伟群、徐涛、郑铁、刘光武。
γ射束立体定向放射治疗系统
第1部分:头部多源γ射束立体
定向放射治疗系统
1 范围
YY0831的本部分规定了头部多源γ射束立体定向放射治疗系统的适用范围、术语、定义、要求和
试验方法。
本部分适用于头部多源γ射束立体定向放射治疗系统(以下简称系统),该系统同时使用多个60Co
密封放射源(可以是运动的,也可以是静止的)对头部病变区域进行聚束照射。
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 9706.1-2007 医用电气设备 第1部分:安全通用要求
GB 9706.15-2008 医用电气设备 第1-1部分:安全通用要求 并列标准:医用电气系统安全
要求
GB 9706.17-2009 医用电气设备 第2部分:γ射束治疗设备安全专用要求
GB/T 17857-1999 医用放射学术语(放射治疗、核医学和辐射剂量学设备)
GB/T 18987-2003 放射治疗设备 坐标系、运动与刻度
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/T 17857-1999界定的以及下列术语和定义适用于本文件。
3.1
定位参考点 referencelocalizationpoint
系统中,当系统处于预定辐照位置时,治疗床及立体定位装置的标定点,用于指示系统的定位中心。
3.2
(聚)焦点 focus
系统中,所有射束轴线的交点。
3.3
(聚)焦平面 focusplane
系统中,通过焦点并垂直于坐标轴的特定平面。
3.4
聚焦野 focusedfieldsize
系统中,在三维焦平面内受照物体规定深度处,由50%的等剂量曲线所限定的区域。
3.5
聚焦野剂量梯度 dosegradientoffocusedfield
系统中,在焦平面内沿坐标轴线在聚焦野边缘的剂量梯度,用剂量分布曲线20%~80%之间的距

YY 0831‐2011 
YY
ICS 11.040.50
C 43
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Stereotactic radiotherapy system with gamma
beam — Part 1. Multi-source stereotactic
radiotherapy system with gamma beam for head
lesion
γ射束立体定向放射治疗系统
第 1部分. 头部多源 γ射束立体定向放射治疗系统
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 1, 2013
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  Requirements ... 5 
5  Test methods ... 8 
Annex A (Informative) Materials, structure and size of special spherical die
body and special focus measuring tools for test ... 15 
Foreword 
All technical contents of this Part are mandatory.
YY 0831 is consisted of 2 parts as follows.
— Part 1. Multi-source stereotactic radiotherapy system with gamma beam for head
lesion;
— Part 2. Multi-source stereotactic radiotherapy system with gamma beam for body
lesion.
This Part is part 1 of YY 0831.
This Part is drafted according to the rules specified in GB/T 1.1-2009.
Please note that some contents in this Document may involve patents. The issuing
authority of this Document does not undertake the responsibilities to identify these
patents.
The part was proposed by China Food and Drug Administration.
The part 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 organization of this Part. Beijing Institute of Medical Device Testing, Shenzhen
Haibo Technology Co., Ltd., Medical Science & Technology Development (Shenzhen) Co.,
Ltd. (MASEP), Shenzhen Shengai Medical Technology Development Co., Ltd., and
Shenzhen Zunrui Technology Co., Ltd.
The main drafters of the part. Zhang Zhaoyuan, Zhang Xin, Song Lianyou, Chen Jing, Zhu
Weiqun, Xu Tao, Zheng Tie, and Liu Guangwu.
Stereotactic radiotherapy system with gamma beam —
Part 1. Multi-source stereotactic radiotherapy system
with gamma beam for head lesion
1  Scope 
This Part of YY 0831 specifies the scope, terms, definitions, requirements, and test
methods of the multi-source stereotactic radiotherapy system with gamma beam for head
lesion.
This Part applies to the multi-source stereotactic radiotherapy system with gamma beam
for head lesion (hereinafter referred to as the system). The system simultaneously uses
multiple 60Co sealed radioactive sources (it may be dynamic or static) to conduct beaming
irradiation to the head lesion.
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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.15-2008 Medical electrical equipment - Part 1. General requirements for safety
- Collateral standard. Safety requirements for medical electrical systems
GB 9706.17-2009 Medical electrical equipment - Part 2. Particular requirements for the
safety of gamma beam therapy equipment
GB/T 17857-1999 Medical radiology – Terminology (Equipment for radiotherapy, nuclear
medicine and radiation dosimetry)
GB/T 18987-2003 Radiotherapy equipment - Coordinates, movements and scales
radiotherapy therapeutic planning systems
c) For the focused field of which the nominal size is greater than 20 mm and less than
or equal to 30 mm, the dose gradient of each focused field shall not exceed 10 mm.
4.6 Deviation of positioning reference point
Deviation of the positioning reference point of the system shall meet the following
requirements.
a) For the minimum focused field, the deviation between the positioning reference point
and the focus shall be less than or equal to 0.5 mm;
b) The deviations of positioning reference point for each focused field shall be included
4.7 Integrated error of dose calculation
For each focused field, the error between the absorbent dose value calculated by the
therapeutic planning software AND the actual measured value shall not exceed ±5%.
4.8 Position error of therapeutic plan reference point
Reconstruction position error of therapeutic planning software shall not exceed 1.5 mm.
4.9 Safety requirements
The system shall meet the requirements of GB 9706.1-2007, GB 9706.15-2008, GB
9706.17-2009 and YY 0637-2012.
5  Test methods 
Check the accompanying documents. It shall comply with the requirements of 4.1.
5.2 Accompanying documents
Check the accompanying documents. It shall comply with the requirements of 4.2.
5.3 Nominal absorbed dose rate of the focus
5.3.1 The ionization chamber and the dosimeter used for measurement shall meet the
requirements of the measurement conditions. Install the special spherical die body
(hereinafter referred to as "Special Die body", see Appendix A) of which the diameter is
160 mm on the positioning bracket. The die body’s center is located at the positioning
reference point. Insert it into ionization chamber, so as to make its effective measurement
therapeutic bed into a predetermined irradiation position. Use the maximum focused field.
minimum focused field;
Dmax — Dosimeter readings at the focus in special spherical die body when using the
maximum focused field.
5.4 Focused field size
5.4.1 Grayscale-dose calibration
Radiate a series of films in the allowed test area of grayscale-dose response curve of the
film. Use a suitable mathematical model according to the radiating dose values and the
corresponding film’s grayscale value, Draw the grayscale-dose response curve for the
5.4.2 Focused field film radiation
According to following steps to respectively measure the maximum deviations of the
focused field size and the nominal value.
a) Select a set of collimator for therapy. Measure at least on 2 focal planes;
b) Put the film of which the size fits the measurement of focused field onto the central
position of special die body. Let the film to be located on some focal plane;
c) Transfer the special die body, together with the therapeutic bed, into focus position.
Start to radiate. Radiation dose shall be within the appropriate response area of the
grayscale-dose response curve of the film used.
operation of c);
e) Replace the collimator. Repeat tests b)-e). Complete the radiation of each group of
focused field;
f) Perform the therapy to the film.
5.4.3 Calculation of focused field size
According to following steps to calculate the focused field size.
a) Use a scanner to scan the film. The resolution shall not be less than 300 DPI.
Respectively scan the focused field films of 5.4.2;
b) Use the grayscale-dose response curve of 5.4.1 to convert the film grayscale TO
c) Separately find out the dose of each film at positioning reference point. Define the
dose value as the 100% dose value of the film;
planning software AND the actual measured absorbed dose value shall comply with the
requirements of 4.7.
Calculate the absorbed doses at 3 reference points. Calculate the relative deviation
according to Formula (6);
                         
Where.
ΔP — Relative deviation between focus planned dose and measured dose, %;
P1 — Actual measured absorbed dose at die body center, in unit of Gy.
5.8 Position deviation of therapeutic planning reference point
According to the image parameter’s requirements that are given by accompanying
documents and are required to achieve the reconstruction precision of three-dimensional
image of therapeutic planning software, fix the imaged head die body that is installed with
3 known target volumes INTO the stereotaxic positioning apparatus. Mount together on an
imaging system to scan, so as to obtain satisfactory image. Input the image data into
therapeutic planning system. Calculate the coordinates of the 3 target volumes.
Respectively calculate the position coordinates of the center of the 3 target volumes in the
three-dimensional image of therapeutic planning software according to Formula (7).
                     
Where.
Δ2 — The distance between the center of the target volume and reconstruction target
volume of therapeutic planning software, in unit of mm (mm);
ΔX2 — In X-axis direction, the distance between the center of the target volume and
reconstruction target volume of therapeutic planning software, in unit of
millimeter (mm);
ΔY2 — In Y-axis direction, the distance between the center of the target volume and
   
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