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Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-2: Determination of the detective quantum efficiency. Detectors used in mammography
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YY/T 0590.2-2010
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Basic data | Standard ID | YY/T 0590.2-2010 (YY/T0590.2-2010) | | Description (Translated English) | Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-2: Determination of the detective quantum efficiency. Detectors used in mammography | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.50 | | Word Count Estimation | 24,299 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB 9706.24; GB/T 20224-2006; YY/T 0063; YY/T 0590.1-2005; IEC 61267-2005; IEC/TR 60788 | | Adopted Standard | IEC 62220-1-2-2007, 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 requirements on manufacturers of medical work under the conditions of use, as the air kerma and function of spatial frequency digital X-ray imaging equipment slow quantum efficiency measurement method sonar. The intended users of this part of the manufacturer and well-equipped testing laboratory. This standard applies to breast X-ray photography of digital imaging X-ray imaging equipment, such as, but not limited to: CR systems, directly or indirectly based flat panel detector systems, scanning system (Tsuen in CCD or photon counter). This section does not apply to: for ordinary X-ray photography or dental photography number of buildings of X-ray imaging equipment through, -CT, for dynamic imaging device (for a series of images, such as fluoroscopy or cardiac imaging). Note |
YY/T 0590.2-2010: Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-2: Determination of the detective quantum efficiency. Detectors used in mammography ---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical electrical equipment.Characteristics of digital X-ray imaging devices.Part 1-2. Determination of the detective quantum efficiency.Detectors used in mammography
ICS 11.040.50
C43
People's Republic of China pharmaceutical industry standards
Medical electrical equipment - digital X-ray imaging apparatus
Characteristics Part 1-2. Determination of the detective quantum efficiency
Breast X-ray photography detectors
devices-Part 1-2. Determinationofthedetectivequantumefficiency-
(IEC 62220-1-2.2007, IDT)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Terms and definitions
Requirement 3 4
3 4.1 Operating Conditions
4.2 X-ray equipment 3
4.3 Radiation quality 3
4.4 Experimental Devices 4
4.5 geometry 5
Irradiation conditions 6 4.6
5 of 8 unprocessed data correction
6 Determination of the quantum detection efficiency of 8
6.1 DQE (u, v) of the definition and formula 8
6.2 8 parameters for evaluation
6.3 determine different parameters of the image 9
7 Declaration of Conformity 11
8 accuracy 12
Appendix A (normative) Hysteresis is determined 13
Annex B (informative) Calculation of input noise power spectrum 15
References 16
Index 17
Foreword
YY/T 0590 "Medical electrical equipment - Characteristics of digital X-ray imaging apparatus" is divided into the following sections.
--- YY/T 0590.1 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1. detective quantum efficiency
Measurement;
--- YY/T 0590.2 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2. detective quantum efficiency measurement
Given breast X-ray photography detectors;
--- YY/T 0590.3 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3. detective quantum efficiency measurement
Given the dynamic photographic detectors.
This section YY/T Section 20590 of.
This section equivalent conversion IEC 62220-1-2.2007 "Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2. amount
Sub-detection efficiency measured with detectors of breast X-ray photography. " And editorial changes as follows.
--- Remove the IEC foreword;
--- Table 2 under the original standard line comment "Context SNR2in calculations are given in Appendix C" to "SNR2in background letter computing
Information is given in Appendix B... "
This part of the National Technical Committee of Standardization for medical appliances medical X-ray equipment and utensils Standardization Technical Committee (SAC/TC10 /
SC1) centralized.
This part mainly drafted by. Space Star Space Applications Limited, Liaoning Medical Device Control, Shanghai Hua nuclear medical line
Child Instruments.
The main drafters of this section. Zou Yuan, Sun Zhiyong, Bai cow bell.
Introduction
Digital X-ray imaging apparatus is becoming widely used in medical diagnostics, and gradually replace the conventional screen film system and mold
Prepared by the X-ray image intensifier television system. Therefore, it is necessary to define the description of digital X-ray imaging device-specific parameters and imaging performance standard
Normalized measurement procedures used.
A growing consensus in the scientific community's view that the detective quantum efficiency (DQE) is a description of X-ray imaging device imaging performance most suitable parameters
number. DQE describe the imaging device from the radiation field to maintain the ability to output digital image data signal to noise ratio. Since the X-ray imaging
, The radiation field of noise and air kerma levels are closely related, DQE values can also be considered a description of a given digital X-ray
Efficiency dose-ray imaging apparatus.
Note. Although DQE has been widely used to describe the performance of the imaging device, but the relationship between the physical parameters and hide observed between the performance has not yet fully
Clear.
DQE is already widely used by the manufacturer to characterize the performance of its digital X-ray imaging devices. DQE specification also made a number of management
Institutions (eg FDA) as a recognized program. There is no standard specification measurement conditions or measurement procedures, resulting in data from different sources
Not comparable.
Therefore, the development of this part of the format to standardize measurement procedures and digital X-ray imaging devices detective quantum efficiency of the declaration of conformity.
In the DQE calculation method recommended in this section, the system response is to assume that all the energy is equal attenuation measured. [5]
The development of this part of manufacturers, users, distributors and regulatory agencies are beneficial. It is a series of standards related to three of the second
section.
Part 1. suitable for X-ray photography, not including breast X-ray photography and fluoroscopy;
This section, namely Part 1-2. suitable for breast X-ray photography;
Part 1-3. suitable for dynamic imaging detector.
These standards can be considered a description of digital X-ray imaging device-related parameters YY/T 0590 series of standards first
section.
Medical electrical equipment - digital X-ray imaging apparatus
Characteristics Part 1-2. Determination of the detective quantum efficiency
Breast X-ray photography detectors
1 Scope
YY/T 0590 provisions of this section under the conditions of use specified by the manufacturer of medical work, as an air kerma and spatial frequency
Method for measuring the digital X-ray imaging equipment detective quantum efficiency function. This section is intended user and equipment manufacturers
Sophisticated testing laboratory.
This section applies to the breast X-ray photography imaging digital X-ray imaging equipment, such as, but not limited to. CR system, either directly or
System, scanning system (based on CCD or photon counter) based indirect flat panel detector. This section does not apply to.
--- For ordinary dental X-ray photography or photography digital X-ray imaging equipment;
--- CT;
--- Devices for dynamic imaging (obtain a series of images, such as fluoroscopy or cardiac imaging).
Note. The reason does not include the above device, since a number of very important parameters they contain different from the breast X-ray photography (for example, the quality of the wiring harness, bit geometry
Position, time-dependent, etc.). The other part of the technical parameters of the series standards (YY/T 0590.1 and IEC 62220-1-3) conducted
It has been described as a description of other parameters of the project, such as processing speed and contrast in IEC and ISO standards.
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 9706.24 Medical electrical equipment - Part 2-45. mammographic X - ray equipment and mammographic stereotactic device security
Full-specific requirements (IEC 60601-2-45, IDT)
GB/T 20224-2006 digital camera exposure index, ISO speed ratings, standard output sensitivity, and recommended exposure index does
Set (ISO /DIS12232.2004, IDT)
YY/T 0063 with diagnostic X-ray tube assemblies focus feature (YY/T 0063-2007, IEC 60336.2005, IDT)
YY/T 0590.1-2005 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1. detective quantum efficiency
(YY/T 0590.1-2005, IDT)
IEC 61267.2005 with diagnostic X-ray equipment with radiation characteristic measurement conditions
IEC TR60788 Definition Medical electrical equipment assembly
3 Terms and Definitions
IEC 60788 define the following terms and definitions apply to this document.
3.1
Conversion function conversionfunction
Different doses of radiation exposure, digital X-ray imaging apparatus of the original image with a large area of the pixel average value per unit area of the detector plane
The radiation dose Q (the number of photons per unit area) of the corresponding curve.
Note 1. Q is measured backscattered remove air kerma, multiplied by the value calculated in Table 2 of 4 obtained.
Note 2. Many calibration laboratories, such as the National Institute of Metrology, Calibration for measuring air kerma dosimeters.
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