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YY/T 0892-2013 English PDF

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YY/T 0892-2013: Methods for the measurement of leakage radiation of medical diagnostic X-ray tube assemblies
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Basic data

Standard ID YY/T 0892-2013 (YY/T0892-2013)
Description (Translated English) Methods for the measurement of leakage radiation of medical diagnostic X-ray tube assemblies
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 7,788
Quoted Standard GB 9706.11-1997; GB 9706.12-1997; GB/T 10149-1988
Regulation (derived from) State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies: medical diagnostic X -ray tube assemblies (hereinafter referred to as tube assembly) radiation leak testing Terminology and definitions, test methods side. This standard applies to: Non -pressure generating device capacitor discha

YY/T 0892-2013: Methods for the measurement of leakage radiation of medical diagnostic X-ray tube assemblies


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Methods for the measurement of leakage radiation of medical diagnostic X-ray tube assemblies ICS 11.040.50 C43 People's Republic of China pharmaceutical industry standards Medical Diagnostic X-ray tube assembly leakage radiation Test Methods Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee on Medical Electrical medical X-ray equipment and utensils Standardization Technical Committee (SAC / TC10/SC1) centralized. This standard was drafted. Liaoning Provincial Medical Device Testing, Siemens Aiks ray Vacuum Technology (Wuxi) Co., Ltd., Hangzhou Chiron Medical Devices Co., Ltd., Hangzhou Wandong Electronics Co. The main drafters of this standard. Wang Bo, Zhang can, Wangsong Dong, Hu Youcheng, Wang Jianjun, Zhang Yong. Medical Diagnostic X-ray tube assembly leakage radiation Test Methods

1 Scope

This standard specifies the diagnostic X-ray tube assemblies (hereinafter referred to as tube assembly) terms and definitions radiation leak test, the test method. This standard applies to the radiation leak testing apparatus tube assembly loaded non-state high voltage capacitor discharge occurs.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 9706.11-1997 Medical electrical equipment - Part II. diagnostic X-ray source assemblies and X-ray tube assemblies Claim GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety Collateral standard diagnostic X-ray equipment. General requirements for radiation protection GB/T 10149-1988 X-ray equipment for medical terminology and symbols

3 Terms and Definitions

GB 9706.11-1997, GB 9706.12-1997, GB/T 10149-1988 definition of terms and definitions apply to this document. Test Method 4 4.1 Test environment conditions Unless otherwise stated, the environmental conditions should be met. a) Ambient temperature. 10 ℃ ~ 40 ℃; b) Relative humidity. 30% to 75%; c) Atmospheric Pressure. 700hPa ~ 1060hPa. 4.2 Spherical Detection Method 4.2.1 The use of instruments and devices Ionization chamber (100cm2, the length of not more than 20cm), stereotype (thickness not less than 4mm) or has an equivalent effect of radiation protection material. 4.2.2 Test layout and step Test layout and the steps in the following way. a) Figure 1 Several ionization chamber placed on a semi-circle with a radius of 1m, the ionization chamber filled with the continuous over the entire semi-circle, and the ionization chamber Receiving surface being the center of the semi-circle;

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