YY/T 1308-2016Automatically-controlled brachytherapy afterloading equipment (English PDF)
自动控制式近距离治疗后装设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 23, 2016
Implementation date
January 1, 2017
Scope
YY/T 1308-2016 is the English-translated version of 自动控制式近距离治疗后装设备.
YY/T 1308-2016 is the Chinese pharmaceutical industry standard for automatic remote afterloading brachytherapy equipment.
It sets the requirements and the test methods, covering the accuracy of the source position and of the dwell times, the source transfer and its verification, the interlocks and the emergency retraction of the source, the radiation protection of the room and the staff, the treatment records and the electrical safety. Issued on 23 March 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1308-2016
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
- Preface
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 Requirements
- 5 Test methods
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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);
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.15-2008Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 17857-1999Medical radiology. Terminology (Equipment for radiotherapy, nuclear medicine and radiation dosimetry)
- YY/T 0973-2016Radiotherapy treatment planning system for automatically- controlled brachytherapy afterloading equipment-Characteristics and test
GB 9706.13-2008
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Related Standards
GB 9706.15-2008 — Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
GB/T 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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YY/T 1308-2016
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