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YY/T 0796.1-2010: Medical electrical equipment. Exposure index of digital X-ray imaging systems. Part 1: Definitions and requirements for general radiography
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Medical electrical equipment. Exposure index of digital X-ray imaging systems. Part 1: Definitions and requirements for general radiography
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Basic data | Standard ID | YY/T 0796.1-2010 (YY/T0796.1-2010) | | Description (Translated English) | Medical electrical equipment. Exposure index of digital X-ray imaging systems. Part 1: Definitions and requirements for general radiography | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 18,162 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | IEC/TR 60788 | | Adopted Standard | IEC 62494-1-2008, IDT | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the digital X-ray imaging system to obtain images of the dawn of the index definitions and requirements. This standard applies under ordinary photographic digital X-ray imaging system for generating projected conventional X-ray imaging applications, such as, but not limited to: light luminescence imaging X-ray photographic plate imaging (CR) systems, flat panel detector The system, optical coupling device (CCD) system. Does not include image intensifier systems and apply the breast or dental imaging systems. This section defines the exposure index is only applicable to a single exposure generated image. Repeated irradiation generated image (for example, fault fusion imaging, dual energy subtraction images veneer pieces or CR imaging) are not included in this section. | YY/T 0796.1-2010: Medical electrical equipment. Exposure index of digital X-ray imaging systems. Part 1: Definitions and requirements for general radiography
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Medical electrical equipment.Exposure index of digital X-ray imaging systems.Part 1. Definitions and requirements for general radiography
ICS 11.040.50
C43
People's Republic of China pharmaceutical industry standards
Medical electrical equipment -
Exposure index of digital X-ray imaging system
Part 1. General X-ray photography of definitions and requirements
Part 1. Definitionsandrequirementsforgeneralradiography
(IEC 62494-1.2008, IDT)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This section is a standard YY/T 0796 "Medical electrical equipment - Digital X-ray imaging system exposure index" Part 1.
This part of IEC 62494-1.2008 "Exposure Index Medical electrical equipment - Part 1 digital X-ray imaging systems. Normal X
Radiography of definitions and requirements, "the degree of consistency is identical with, the main difference is the reference to IEC standards has been converted to a national or
Industry standards, replaced by the corresponding national or industry standards.
This part of the National Medical X-ray equipment and utensils Standardization Technical Committee (SAC/TC10/SC1) centralized.
This section is drafted. Beijing Wandong Medical Equipment Co., Ltd., General Electric (China) Co., Ltd. Medical Systems.
The main drafters of this section. Xie Yufeng, Huang Jiaxiang, Lu Jinming Wang khun.
Introduction
In screen film X-ray imaging system, the detection surface of the received radiation exposure, and the optical density of the film has been established to direct
Should the relationship, but this does not apply to digital X-ray imaging system. In the digital X-ray photography often use automated image processing techniques to obtain
Constant imaging features, it can not determine the amount of exposure deviation (such as overexposure and underexposure) according to the brightness of the image deviation. usually
Case, underexposure can cause digital image noise level increases, more noteworthy is (from the radiation protection point of view) in the number of overexposed
Word image can not be easily identified.
Therefore, different digital X-ray imaging system manufacturers are proposed different concept of "exposure index." These indicators are the root of exposure
According to the original image data obtained by numerical calculation, to judge exposure level detector. However, different manufacturers of X-ray imaging system
EC, the exposure indicator to define and measure its provisions are different. Therefore, it is necessary to unify the exposure to all the provisions of the digital X-ray imaging system
Index and simplify its application, to facilitate the establishment of appropriate exposure guidelines. Especially different manufacturers photography system in the same department
When this uniform exposure index more necessary.
This section defines the concept of exposure index, proposed definitions, scope and general requirements for exposure index. Arithmetic processing details (software shipped
Algorithm is) not considered in this section to avoid restricting the technological progress.
Exposure Index enables the operator to determine. the image on the detector exposure level is appropriate to obtain the desired level of image quality. value
It is noteworthy that, defined in this part of the exposure index is calculated based on the image signal, and thus the energy absorbed by the detector related. Since the
The quality of a radiation detector using a predetermined calibration only, so the air exposure index detector surface kerma no direct
contact. Therefore, this part of the definition of exposure index suitable for the image quality of digital photography, the image quality is mainly determined by the level of signal to noise ratio,
The signal to noise ratio is determined by the level and energy absorption detector.
Appendix A provides basic principle concerning exposure index, details about the characteristics and use.
In order to obtain a suitable image quality, the detector exposure level (ie, corresponding exposure index) may be based on examination of a body part, side view
Or a different type of X-ray systems change. This section describes the second parameter, the deviation index for the quantitative description of the actual exposure
Index with a suitable exposure index (target exposure index) bias. This parameter can not be used to accurately measure the amount of exposure detectors acceptable and
Is to provide a simple way for the operator to check whether the appropriate amount of exposure.
Appendix B provides basic principle concerning deviation index, details about the characteristics and use.
Exposure Index (index and offset) may be recorded in the tag field of DICOM files to facilitate the image detector dose level documents
Records and communications.
Exposure index does not limit the use of patient radiation dose parameters describe a method of exposure, such as the reference air kerma or kerma
Kinetic Area product. Because the relationship between the exposure of patients and the detector exposure amount is determined by many factors, and these factors are usually in clinical status
We can not know, so the exposure index can not be used to calculate or estimate patient doses.
Medical electrical equipment -
Exposure index of digital X-ray imaging system
Part 1. General X-ray photography of definitions and requirements
1 Scope
YY/T 0796 This section specifies the definitions and requirements to obtain images from the digital X-ray imaging system exposure index.
This section applies to digital X-ray imaging system under ordinary photography for routine applications produce a projected X-ray image, for example, but
Are not limited to.
● PSL X-radiography (CR) imaging plate imaging systems;
● flat-panel detector system;
● Optical coupling device (CCD) system.
It does not include the image intensifier system and applied to the breast or dental imaging system.
This section defines the exposure index applies only to single-exposure image generated. Images generated by irradiation many times (for example, fault Fusion Movies
Like, dual energy subtraction image or CR veneer Multiple imaging) are not included in this section.
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.
Medical electrical equipment IEC TR60788 terms, definitions compilation
3 Terms and Definitions
IEC 60788 and defined by the following terms and definitions apply to this document.
3.1
Calibration conditions calibrationconditions
Conditions require exposure index calibration.
3.2
Calibration function calibrationfunction
This function describes the value of interest with respect to image receptor function of air kerma, accurate and effective under calibration conditions.
3.3
Detector surface detectorsurface
Closest to the image receptor plane can reach areas.
Note. After all the parts out of the rays of the radiation beam, these components (if applicable, including grids and automatic exposure control components, etc.) can be safely removed without damaging
Injury digital X-ray detector.
[YY/T 0590.2-2010, the definition 3.3]
3.4
Bias Index deviationindex
DI
Exposure index used to quantify the actual value and the target exposure index bias.
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