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YY/T 0888-2013

Chinese Standard: 'YY/T 0888-2013'
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Detail Information of YY/T 0888-2013; YY/T0888-2013
Description (Translated English): Imaging dose of X-ray image-guided devices used in radiotherapy equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.60
Word Count Estimation: 6,645
Quoted Standard: GB 9706.5-2008; GB/T 17857-1999
Drafting Organization: Beijing Medical Device Testing
Administrative Organization: National Technical Committee of Standardization for medical electrical radiation therapy, nuclear medicine and radiation Standardization Technical Committee dosimetry equipment
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization: State Food and Drug Administration
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies: X -ray radiation therapy devices for image-guided device imaging dose test methods and random files requirements. This standard applies to: X -ray radiation therapy devices for image-guided devices.

YY/T 0888-2013
YY
ICS 11.040.60
C 43
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Imaging dose of X-ray image-guided devices
used in radiotherapy equipment
放射治疗设备中 X射线图像引导装置的成像剂量
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 General requirements ... 6 
5 Description of CTGD imaging dose using kV-level X-ray source ... 6 
6 Description of CTGD imaging dose using MV-level X-ray source ... 8 
Foreword
This Standard was drafted in accordance with the provisions given in the GB/T
1.1-2009.
Please pay attention that some contents in this document might involve patents.
The issuing authority of this document does not undertake the responsibility for
the identification of these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of the Technical Sub-committee of
the Equipment for Radiotherapy, Nuclear Medicine and Radiation Dosimetry of
the National Technical Committee for Standardization of Medical Electrical
Equipment (SAC/TC 10/SC 3).
Drafting organizations of this Standard. Beijing Institute of Medical Device
Testing, and Cancer Hospital Chinese Academy of Medical Sciences.
Main drafters of this Standard. Zhang Xin, Dai Jianrong, and Yan Xu.
Imaging dose of X-ray image-guided devices
used in radiotherapy equipment
1 Scope
This Standard specifies the test methods for the imaging dose of X-ray image-
guided devices used in radiotherapy equipment, and the requirements for the
accompanying file.
This Standard applies to the X-ray image-guided devices used in radiotherapy
equipment.
2 Normative references
The following documents are essential to the application of this document. For
dated references, only the versions with the dates indicated are applicable to
this document. For undated references, only the latest versions (including all
the amendments) are applicable to this document.
GB 9706.5-2008 Medical electrical equipment – Part 2. Particular
requirements for the safety of electron accelerators in the range 1 MeV to 50
MeV
GB/T 17857-1999 Medical radiology – Terminology (Equipment for
radiotherapy, nuclear medicine and radiation dosimetry)
3 Terms and definitions
The terms and definitions defined in the GB/T 17857-1999 and the following
ones apply to this document.
3.1 Image guided radiotherapy; IGRT
It refers to the radiotherapy that the treatment parameters (including the
patients’ positions) are adjusted according to various modes of image
information, obtained before or during fractionated treatment.
3.2 Computed tomographic guidance device; CTGD
The computed tomographic guidance devices refer to the devices that use
computed tomography for image guidance in the radiotherapy equipment.
the measurement, the insertion pieces which are the same with the phantom
materials shall be completely inserted into the holes.
5.2 CTDI100 dose instructions in the accompanying files
5.2.1 For the CTGD devices using kV-level X-ray source in the IGRT
equipment, the phantom specified in the Article 5.1 shall be used for obtaining
the following dose information. For any CTGD scanning devices, the dose
information of each application (such as head, body, etc.) shall be respectively
provided in the accompanying files. The dose phantom shall be placed on the
treatment beds during the measurement, and the measurement shall be
conducted without any additional attenuating materials. The dose phantom
shall be placed in the center of the scanning area, and shall be located on the
rotation axis of the CTGD scanning device.
5.2.2 For each application, the information that shall be provided in the
accompanying files is as follows.
5.2.2.1 The dose phantom specified in the Article 5.1 shall be used under the
CTGD operating conditions (shall be the typical values recommended by
manufacturers). The CTDI100 values shall be measured on the following
locations.
a) INSERT the radiation detector into the measuring hole on the phantom
center. MOVE the treatment bed along the axis, so as to find out the
location of the maximum CTDI100 value, and to obtain the CTDI100(center) for
the rotation axis of the phantom.
b) INSERT the radiation detector into a certain measuring hole which is
10mm inward the phantom surface along the parallel line of the rotation
axis.
c) Respectively ROTATE 90°, 180° and 270° along the rotation axis of the
phantom from the location of b). The position when the CTDI100 value
comes up to the maximum shall be given according to the provisions
specified in b) a......
Related standard:   YY/T 0887-2013  YY/T 0889-2013
   
 
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