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YY/T 1308-2016: Automatically-controlled brachytherapy afterloading equipment
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1308-2016 | English | 139 |
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Automatically-controlled brachytherapy afterloading equipment
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YY/T 1308-2016
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Basic data | Standard ID | YY/T 1308-2016 (YY/T1308-2016) | | Description (Translated English) | Automatically-controlled brachytherapy afterloading equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 7,738 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | 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 | YY/T 1308-2016: Automatically-controlled brachytherapy afterloading equipment---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.
Automatically controlled by brachytherapy afterloading equipment
ICS 11.040.60
C43
People's Republic of China Pharmaceutical Industry Standard
Automatic control of close-range treatment equipment
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 Requirements 1
5 Test methods 3
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., Medical (Shanghai) medical equipment
Machinery Co., Ltd., Jiangsu Haiming Medical Devices Co., Ltd., Varian Medical Devices Trading (Beijing) Co., Ltd.
The main drafters of this standard. Zhang Xin, Zhang Chengbao, Chen Jing, Miao Binhe, Chen Pu, Song Lei, Wang Peichen, Li Yue Ling.
Automatic control of close-range treatment equipment
1 Scope
This standard specifies the requirements and test methods for automatic controlled follow-up equipment.
This standard applies to automatic control of close-up treatment equipment (hereinafter referred to as "post-installed equipment").
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.
Medical electrical equipment - Part 1. General requirements for safety GB 9706.1-2007
GB 9706.13-2008 Medical electrical equipment - Part 2. Particular requirements for automatic safety of controlled equipment for close proximity treatment
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety requirements
GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing
GB/T 17857-1999 Medical radiology terminology (Radiation therapy, nuclear medicine and radiation dosimetry equipment)
Safety Requirements for Radiotherapy Planning System for Medical Electrical Equipment YY 0637
Safety of medical records and verification systems for medical electrical equipment YY 0721-2009
YY/T 0973-2016 Automatic control of close-range treatment of equipment after radiotherapy planning system performance and test methods
3 terms and definitions
GB 9706.13-2008, GB/T 17857-1999 The terms and definitions defined apply to this document.
4 requirements
4.1 random files
The random file should provide the following.
a) the number of treatment channels available for post-installation equipment;
b) the maximum transmission distance of the radioactive source;
c) the length of the radiation source line (braid);
d) the adjustable range of the distance between the dwells;
e) the maximum number of dwell points and the distance between the corresponding dwells;
f) the maximum transfer time from the source to the station;
g) the time range at which the radioactive source can stay at the station;
h) Lifting range of rear machine equipment;
i) the minimum radius of curvature allowed for the post-installation equipment radioactive source, and the inner diameter of the corresponding source;
j) The configuration of the source device (including name, type, number, material, structure, applicable location, life, disinfection,
Method, connection method);
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