YY/T 0888-2013Imaging dose of X-ray image-guided devices used in radiotherapy equipment (English PDF)
放射治疗设备中X射线图像引导装置的成像剂量
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 0888-2013 is the English-translated version of 放射治疗设备中X射线图像引导装置的成像剂量.
YY/T 0888-2013 is the Chinese pharmaceutical industry standard that gives the test methods for the imaging dose of the X-ray image-guided devices used with radiotherapy equipment, and the requirements that go with them.
It covers the dose delivered to the patient by the imaging itself, the way that dose is measured with a phantom and reported for each imaging mode, and the information the manufacturer must give about it. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 0888-2013
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 definitions4
- 4 General requirements6
- 5 Description of CTGD imaging dose using kV-level X-ray source6
- 6 Description of CTGD imaging dose using MV-level X-ray source8
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.
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
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
5.1 Phantom of CTGD imaging dose using
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
5.2.2.4 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.
5.2.2.3 The mean value of CTDI100(periphery) under each selectable CTGD
operating condition.
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. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
GB 9706.5-2008 — Medical electrical equipment -- Part 2-1: 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)
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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