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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

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