YY/T 0745-2009Particular specifications for remote control radioscopy X-ray equipment (English PDF)
遥控透视X射线机专用技术条件
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
November 25, 2009
Implementation date
December 1, 2010
Scope
YY/T 0745-2009 is the English-translated version of 遥控透视X射线机专用技术条件.
YY/T 0745-2009 sets the particular technical conditions for remote control fluoroscopy X-ray machines in China.
It defines what such a machine is made of, namely the X-ray generating equipment, the remote control console, the patient support and the image intensifier television system, and lays down the requirements and the test methods used to verify them.
Safety is tied to the GB 9706 series for high-voltage generators, X-ray tube assemblies, radiation protection and associated equipment, while terminology follows GB/T 10149.
The standard covers upright remote-controlled fluoroscopy units used by medical diagnostic departments for routine fluoroscopic examinations. General diagnostic X-ray machines that merely offer a fluoroscopy function fall outside it. Issued on 25 November 2009, it has applied since 1 December 2010.
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Document preview — YY/T 0745-2009
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C 43
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 1 Scope
- 2 Normative reference documents
- 3 Terminology
- 4 Composition
1 Scope
This standard specifies the composition, requirements and test methods of the remote control perspective X-ray machine (hereinafter referred to as remote control perspective machine).
This standard applies to the remote perspective X-ray machine for standing perspective, which can be used for routine medical examination of medical diagnostic units Use.
This standard does not apply to general diagnostic X-ray machines with perspective functions.
2 Normative reference documents
The terms of the following documents are hereby incorporated by reference into this standard. Whichever is the date of the reference file, which is followed by all (Excluding corrigenda) or revisions do not apply to this standard, however, encourage the parties to reach an agreement under this standard Whether you can use the latest version of these files. For undated references, the latest edition applies to this standard.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.3-2000 Medical electrical equipment - Part 2. Particular requirements for the safety of high pressure generators for diagnostic X - ray devices (Idt IEC 60601-2-7.:1998)
GB 9706.11-1997 Medical electrical equipment - Part 2. Medical diagnostic X - ray source assemblies and X - ray tube assemblies - Safety - specific Requirements (idt IEC 60601-2-28.:1993)
Medical electrical equipment - Part 1. General requirements for safety III. Parallel standard diagnosis of X - ray radiation General requirements for protection (idt IEC 60601-1-3.:1994)
Medical electrical equipment - Part 2. Particular requirements for the safety of ancillary equipment for X - ray equipment (idt IEC ) GB 9706.14-1997. 60601-2-32..1994)
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General safety requirements Parallel standard. Medical electrical system safety (IEC 60601-1-1.:2000, IDT)
GB/T 10149 Medical X-ray equipment - Terms and symbols
YY/T 0106-2008 General specification for medical diagnostic X-ray machines
YY/T 0291-2007 Medical diagnostic X-ray equipment - Environmental requirements and test methods
YY/T 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2:2001, IDT)
YY/T 0608-2007 General technical conditions for medical radiography of medical radiography (X-ray image intensifier)
3 Terminology
The terms and definitions established in GB/T 10149 apply to this standard.
4 Composition
Remote control of the main components of the machine.
a) X-ray generating means;
b) remote control console;
c) patient support device;
d) Image intensifier TV system.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.15-2008Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
- GB/T 10149Terminology and symbol for medical X-ray equipment
- YY/T 0106-2008General specifications for medical diagnostic X-ray equipment
- YY/T 0291-2007Environmental requirements and test methods for medical X-ray equipment
GB 9706.3-2000 · GB 9706.11-1997
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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 10149-1988 — Terminology and symbol for medical X-ray equipment
YY/T 0106-2008 — General specifications for medical diagnostic X-ray equipment
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YY/T 0745-2009
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