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YY/T 0888-2013 PDF English

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YY/T 0888-2013: Imaging dose of X-ray image-guided devices used in radiotherapy equipment
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YY/T 0888-2013: Imaging dose of X-ray image-guided devices used in radiotherapy equipment

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0888-2013
YY ICS 11.040.60 C 43 PHARMACEUTICAL INDUSTRY STANDARD Imaging dose of X-ray image-guided devices used in radiotherapy equipment 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.

4 General requirements

4.1 Description and display of imaging dose For the X-ray imaging devices used in radiotherapy, the expected imaging dose generated under the predetermined imaging conditions shall be described in the user document, and shall be displayed before imaging. The unit specified in the imaging conditions shall be applied to this imaging dose.

5 Description of CTGD imaging dose using kV-level X- ray source

5.1 Phantom of CTGD imaging dose using kV-level X-ray source For the CTGD devices using kV-level X-ray source in the IGRT equipment, the phantom for measuring the imaging dose shall meet the following requirements. The dose phantom is composed of the cylinders made of polymethylmethacrylate (PMMA) with the density of (1.19 ± 0.01) g/cm3. 5.2 CTDI100 dose instructions in the accompanying files 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. 5.2.2.2 For each selectable CTGD operating condition, the modification of CTDI100(center) values will change the CTDI100 values in the center of the dose phantom. The CTDI100(center) values shall be expressed by the normalized CTDI100 values 5.2.2.3 The mean value of CTDI100(periphery) under each selectable CTGD operating condition. 5.2.2.4 The manufacturers shall explain the maximum deviation of the measuring values given in the Articles 5.2.2.1 to 5.2.2.3.The deviation of all the measuring values shall not be greater than the maximum deviation. LOOK up the accompanying files and CHECK the test results of manufacturers, so as to verify whether to meet the requirements.

6 Description of CTGD imaging dose using MV-level X-ray source

6.1 For the CTGD devices using MV-level X-ray source, the imaging dose on the reference point within the 3D imaging volume shall be obtained by one of the following methods. 6.2 The appropriate dose phantom shall be stipulated in the accompanying files. The length shall be at least 1cm beyond the edges on both sides of the maximum available layer slice thickness of devices. 6.3 The accompanying files shall include. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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