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YY/T 1542-2017 English PDF

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YY/T 1542-2017: Evaluation method of automatic exposure control in digital medical X-ray equipment
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Basic data

Standard ID YY/T 1542-2017 (YY/T1542-2017)
Description (Translated English) Evaluation method of automatic exposure control in digital medical X-ray equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 15,111
Date of Issue 2017-05-02
Date of Implementation 2018-04-01
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 49
Issuing agency(ies) State Food and Drug Administration

YY/T 1542-2017: Evaluation method of automatic exposure control in digital medical X-ray equipment


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Evaluation method of automatic exposure control in digital medical X-ray equipment ICS 11.040.50 C43 People's Republic of China pharmaceutical industry standards Digital medical X-ray equipment automatic exposure control Evaluation method X-rayequipment 2017-05-02 released 2018-04-01 implementation State Food and Drug Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Medical Standardization Technical Committee Medical X-ray equipment and appliances Standardization Technical Committee (SAC/TC10 / SC1) centralized. This standard was drafted by Liaoning Provincial Medical Device Testing Institute, Shenzhen Anke High-tech Co., Ltd. The main drafters of this standard. Jin Yu Bo, Wu Guohui, Meng Zhaoyang, Jinxin. Digital medical X-ray equipment automatic exposure control Evaluation method

1 Scope

This standard specifies the digital medical X-ray device automatic exposure control evaluation method. This standard applies to digital X-ray equipment automatic exposure control evaluation, the use of other methods of X-ray automatic control system X-ray equipment can refer to this evaluation method. This standard does not apply to breast X-ray equipment, radiotherapy simulation equipment, computer tomography equipment and panoramic dental X-ray equipment.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 9706.3-2000 Medical electrical equipment - Part 2 - High-voltage generators for diagnostic X-ray generator safety-specific requirements Medical X - ray equipment - Terms and symbols

3 Terms and definitions

GB/T 10149-1988 defined and the following terms and definitions apply to this document. 3.1 Automatic control system automaticcontrolsystem In an X-ray apparatus, the power supplied to the X-ray tube assembly is measured by one or several doses of radiation or corresponding physical quantities Control or limit the system. 3.2 Automatic Exposure Control automaticexposurecontrol; AEC In X-ray equipment, one or more loading factors are automatically controlled to obtain the desired mode of radiation at the preselected location formula. Automatic exposure control is also known as automatic exposure control. 3.3 Automatic exposure rate control automaticexposureratecontrol In X-ray devices, the radiation dose rate is automatically controlled by the control of one or more loading factors so that, at the preselected location and The mode of operation to obtain the desired amount of radiation for a predetermined loading time. 3.4 Automatic intensity control automaticintensitycontrol In X-ray equipment, one or more loading factors are automatically controlled in order to obtain the desired radiation dose rate at a pre-selected location mode.

4 Evaluation Method Overview

4.1 The general conditions to be considered in the evaluation The purpose of this evaluation method is to demonstrate that the specified characteristics of the equipment are within specified tolerances and that some of the requirements are compulsory by law and others