YY 0831.1-2011Stereotactic radiotherapy system with gamma beam - Part 1: Multi-source stereotactic radiotherapy system with gamma beam for head lesion (English PDF)
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
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY 0831.1-2011 is the English-translated version of 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.
YY 0831.1-2011 is the Chinese pharmaceutical industry standard for the multi-source gamma beam stereotactic radiotherapy system used on lesions of the head, the machine that focuses many sealed cobalt-60 sources on a target in the brain.
It is the first part of the YY 0831 series and gives the scope, the terms and definitions, the requirements and the test methods, covering the dose rate at the focus and the size and shape of the focal dose distribution, the accuracy of the positioning and of the treatment time, the collimator helmets, the leakage radiation, the interlocks and the emergency return of the sources. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY 0831.1-2011
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Terms and definitions5
- 4 Requirements5
- 5 Test methods8
- Annex A (Informative) Materials, structure and size of special spherical die body and special focus measuring tools for test15
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.
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
YY 0637-2012 Medical electrical equipment - Requirements for the safety of radiotherapy therapeutic planning systems
4 Requirements
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 in accompanying documents.
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
5.1 Coordinate system
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 point to coincide with the die body's center. Transfer the special die body along with the 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 radiation films used.
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.
d) Repeat b). Let the film to be located on another focal plane. Repeat the radiation 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 corresponding dose values. Draw a dose distribution curve on directions of 3 axes.
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.
deltaP - Relative deviation between focus planned dose and measured dose, %;
P0 - Planned dose at die body center (i.e., focused plan dose), in unit of Gy;
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 3 directions of X, Y, Z. Calculate the reconstruction position deviation of the three-dimensional image of therapeutic planning software according to Formula (7). Where.
delta2 - The distance between the center of the target volume and reconstruction target volume of therapeutic planning software, in unit of mm (mm);
deltaX2 - 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); […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.15-2008Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
- GB/T 17857-1999Medical radiology. Terminology (Equipment for radiotherapy, nuclear medicine and radiation dosimetry)
- GB/T 18987-2003Radiotherapy equipment -- Coordinates, movements and scales
- YY 0637-2012Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems
GB 9706.17-2009
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Related Standards
GB 9706.15-2008 — Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
GB/T 17857-1999 — Medical radiology. Terminology (Equipment for radiotherapy, nuclear medicine and radiation dosimetry)
YY 0831.2-2015 — Stereotactic radiotherapy system with gamma beam - Part 2: Multi—Source stereotactic radiotherapy system with gamma beam for body lesion
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