YY/T 0971-2016 English PDF

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YY/T 0971-2016: Multi-element beam limiting device used in radiotherapy. Characteristics and test methods
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
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Basic data

Standard ID: YY/T 0971-2016 (YY/T0971-2016)
Description (Translated English): Multi-element beam limiting device used in radiotherapy. Characteristics and test methods
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C43
Classification of International Standard: 11.040.60
Word Count Estimation: 11,131
Date of Issue: 2016-03-23
Date of Implementation: 2017-01-01
Quoted Standard: GB 9706.5; GB 9706.17; GB 15213-2016; GB/T 17857; GB/T 18987; YY 0096
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the scope, terminology, performance requirements and test methods for a multi-limiting device for radiotherapy (hereinafter referred to as multiple limiting devices). This standard is applicable to a multi-limiting device which is expected to be fitted outside the radiation head of an external radiation therapy machine (hereinafter referred to as a therapeutic machine), which is used in conjunction with a treating machine to perform radiotherapy on a tumor lesion area. This standard does not apply to multi-limiting devices intended to be assembled inside the radiator head of the treatment machine and only in both open and closed states.

YY/T 0971-2016: Multi-element beam limiting device used in radiotherapy. Characteristics and test methods

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Multi-element radio limiting device used in radiotherapy.Characteristics and test methods ICS 11.040.60 C43 People's Republic of China Pharmaceutical Industry Standard Multi - limiting device for radiotherapy Performance and test methods 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Appliances Standardization Technical Committee of Radiation Therapy, Nuclear Medicine and Radiation Dosing Equipment Subcommittee (SAC/TC10/SC3). The drafting of this standard. Beijing Medical Devices Testing Institute, Shandong Xinhua Medical Devices Co., Ltd., Dalian Modern High-tech Group Limited company. The main drafters of this standard. Jiao Chunying, Cheng Xi Ge, Han Jun, Li Yue Ling. Multi - limiting device for radiotherapy Performance and test methods

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 article Pieces. 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 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. 3.1 Multi-elementbeamlimitingdevice A prescribed number of radiation attenuating elements, assembled and controlled to define a radiation field, either temporarily or permanently An existing limiter device.

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; ......

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