YY/T 0971-2016Multi-element beam limiting device used in radiotherapy- Characteristics and test methods (English PDF)
放射治疗用多元限束装置性能和试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 0971-2016 is the English-translated version of 放射治疗用多元限束装置性能和试验方法.
YY/T 0971-2016 is the Chinese pharmaceutical industry standard for the multi-element beam limiting device, the multileaf collimator mounted outside the treatment head of an external beam radiotherapy machine.
It gives the scope, the terminology, the performance requirements and the test methods, covering the accuracy and reproducibility of the leaf positions, the leakage and transmission between and through the leaves, the penumbra, the shape of the field formed and the interlocks. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 0971-2016
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C 43
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
- 4 Requirements
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the scope, terminology, performance requirements and test of the multi-limiting device for radiotherapy (hereinafter referred to as multiple limiting devices) Test method.
This standard is applicable to the multi-limiting device which is expected to be installed outside the radiation head of the external radiation therapy machine (hereinafter referred to as the treatment machine).
Set with the treatment machine used in the tumor lesion area for radiation therapy.
This standard does not apply to multi-limiting devices that are expected to be assembled inside the radiator head of the treatment machine and only open or close.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB 9706.5 Medical electrical equipment - Part 2. Particular requirements for the safety of electronic accelerators of 1 MeeV to 50 MeV
GB 9706.17 Medical electrical equipment - Part 2. Particular requirements for the safety of gamma beam treatment equipment Performance and test methods for medical electronic accelerators GB 15213-2016 A prescribed number of radiation attenuating elements, assembled and controlled to define a radiation field, either temporarily or permanently An existing limiter device.
GB/T 17857 Medical Radiology Terminology (Radiation Therapy, Nuclear Medicine and Radiation Dosage Equipment) Coordinate, motion and scale of radiotherapy equipment GB/T 18987
YY 0096 cobalt-60 long-distance treatment machine
3 Terms and definitions
GB 15213-2016, GB 9706.5, GB/T 17857 and the following terms and definitions apply to this document.
4 Requirements
4.1 Random files
The random file should contain at least the following.
a) the coordinate system used by the multiple limiting device, and the relationship with the coordinate system defined in ISO /IEC 15987;
b) The use of the treatment machine should be consistent with GB 15213-2016 and GB 9706.5 requirements or YY 0096 and GB 9706.17 The request;
c) applicable radiant energy range;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.5Medical electrical equipment -- Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
- GB/T 17857Medical radiology. Terminology (Equipment for radiotherapy, nuclear medicine and radiation dosimetry)
- YY 0096Co-60 teletherapy unit
GB 9706.17
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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 0096-1992 — Co-60 teletherapy unit
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YY/T 0971-2016
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