YY/T 1542-2017 (YY/T1542-2017, YYT 1542-2017, YYT1542-2017) & related versions
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Evaluation method of automatic exposure control in digital medical X-ray equipment
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YY/T 1542-2017: PDF in English (YYT 1542-2017)
YY/T 1542-2017
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
......
| 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 | 15,176 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Liaoning Province Medical Device Testing Institute, Shenzhen Anke High-tech Co., Ltd. | | Administrative Organization | National Medical Appliance Standardization Technical Committee Medical X-ray equipment and appliances Standardization Technical Committee (SAC/TC 10/SC 1) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 49 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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