YY/T 0892-2013Methods for the measurement of leakage radiation of medical diagnostic X-ray tube assemblies (English PDF)
医用诊断X射线管组件泄漏辐射测试方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 0892-2013 is the English-translated version of 医用诊断X射线管组件泄漏辐射测试方法.
YY/T 0892-2013 is the Chinese pharmaceutical industry standard that gives the methods for measuring the leakage radiation of a medical diagnostic X-ray tube assembly.
It specifies the terms and definitions and the test method, and it applies to tube assemblies that are not loaded by a high voltage capacitor discharge, setting out the loading conditions, the measuring distance and the positions around the assembly, the detector and the way the leakage is expressed. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 0892-2013
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
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
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 °C ~ 40 °C;
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
GB 9706.12-1997 — Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
GB/T 10149-1988 — Terminology and symbol for medical X-ray equipment
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 0892-2013
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