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YY/T 0590.1-2018 English PDF

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YY/T 0590.1-2018: Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1: Determination of the detective quantum efficiency. Detectors used in radiographic imaging
Status: Valid

YY/T 0590.1: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0590.1-2018English554 Add to Cart 3 days [Need to translate] Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1: Determination of the detective quantum efficiency. Detectors used in radiographic imaging Valid YY/T 0590.1-2018
YY/T 0590.1-2005English959 Add to Cart 6 days [Need to translate] Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1: Determination of the detective quantum efficiency Obsolete YY/T 0590.1-2005

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Basic data

Standard ID YY/T 0590.1-2018 (YY/T0590.1-2018)
Description (Translated English) Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1: Determination of the detective quantum efficiency. Detectors used in radiographic imaging
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 29,277
Date of Issue 2018-11-07
Date of Implementation 2019-11-01
Older Standard (superseded by this standard) YY/T 0590.1-2005
Quoted Standard YY/T 0481-2016; IEC 60336; IEC/TR 60788-2004
Adopted Standard IEC 62220-1-1-2015, IDT
Regulation (derived from) Announcement No. 87 of 2018 by the State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the method for determining the quantum detection efficiency (DQE) of a digital X-ray imaging device operating as a function of air kerma and spatial frequency under the medical conditions specified by the manufacturer. The target users of this standard of YY/T 0590 are manufacturers or well-equipped testing laboratories. The scope of application of this standard is limited to digital X-ray imaging devices for single exposure imaging, such as, but not limited to, CR systems, systems based on direct or indirect flat panel detectors. The YY/T 0590 series of standards is not recommended for image intensifier-based X-ray imaging systems. YY/T 0590 This standard does not apply to: digital X-ray imaging devices used in mammography or dental photography; line-scan digital X-ray imaging devices;

YY/T 0590.1-2018: Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1: Determination of the detective quantum efficiency. Detectors used in radiographic imaging



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Medical electrical equipment.Characteristics of digital X-ray imaging devices. Part 1. Determination of the detective quantum efficiency. Detectors used in radiographic imaging ICS 11.040.50 C43 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0590.1-2005 Characteristics of digital X-ray imaging equipment for medical electrical equipment Part 1-1. Determination of quantum detection efficiency General photography detector Part 1.Determinationofthedetectivequantumefficiency-Detectorsusedin (IEC 62220-1-1..2015, IDT) 2018-11-07 released.2019-11-01 implementation State Drug Administration issued

Foreword

YY/T 0590 "Characteristics of Digital X-ray Imaging Devices for Medical Electrical Equipment" is divided into three parts. --- Part 1. Determination of quantum detection efficiency - detectors for general photography; --- Part 2. Determination of quantum detection efficiency - detector for mammography; --- Part 3. Determination of quantum detection efficiency - detector for dynamic imaging. This part is the first part of YY/T 0590. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY/T 0590.1-2005 "Characteristics of digital X-ray imaging devices for medical electrical equipment - Part 1. Quantum exploration Determination of measurement efficiency. Compared with YY/T 0590.1-2005, the main technical changes in this section are as follows. --- Revised the half-value layer of the radiation quality (see 4.3, 4.3 of the.2005 edition); --- Revised the test method for hysteresis in Appendix A (see Appendix A, Appendix A of the.2005 edition); ---Modified the MTF measurement part of the modulation transfer function in the original standard 6.3.3, limiting the test method to obtain the final average MTF (Only the method of using the average edge spread function ESF is allowed) (see 6.3.3, 6.3.3 of the.2005 edition); --- As an option, a description of the measured MTF and noise power spectrum NPS at 45° is added (see 6.3.2.2 and 6.3.3). This section is equivalent to the International Electrotechnical Commission IEC 62220-1-1.2015 "medical electrical equipment digital X-ray imaging device characteristics Part 1-1. Determination of quantum detection efficiency - detectors for general photography. The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows. ---YY/T 0063-2007 medical electrical equipment medical diagnostic X-ray tube assembly focus characteristics (IEC 60336.2005, IDT). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This part is proposed by the State Drug Administration. This part is divided into the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliance Sub-Technical Committee (SAC/TC10/ SC1). This section drafted by. Liaoning Medical Device Inspection and Testing Institute, Shanghai Pinhao Imaging Technology Co., Ltd., Derunte Digital Imaging Technology (Beijing) Co., Ltd., Shanghai Ruirui Optoelectronics Technology Co., Ltd., Beijing Medical Science and Technology Development Center, Jiangsu Kangzhong Digital Medical Equipment Limited. The main drafters of this section. Sun Zhiyong, Meng Zhaoyang, Li Yuxin, Zhang Junyi, Jin Libo, Tang Dongsheng, Liu Jianqiang. The previous versions of the standards replaced by this section are. ---YY/T 0590.1-2005.

Introduction

Digital X-ray imaging devices are increasingly used in medical diagnostics and are widely replacing conventional (analog) imaging devices Such as screen-chip system or analog X-ray image intensifier TV system. It is therefore necessary to define a specific imaging depicting a digital X-ray imaging device. Performance parameters are standardized and the measurement procedures used. The growing consensus in the scientific community is that quantum detection efficiency (DQE) is the most suitable parameter for describing the imaging performance of X-ray imaging devices. DQE describes the ability of an imaging device to maintain a signal-to-noise ratio from the radiation field to the output of digitized image data. Radiation field in X-ray imaging The noise in the air is closely related to the air kerma level, so the DQE value can also be used as a description for a given digital X-ray imaging device. Dose efficiency. Note 1. Although DQE has been widely used to describe the performance of imaging devices, the relationship between this physical parameter and the behavior of human observers has not been Fully understand [1], [3] 1). Note 2. YY/T 0457.5-2003 specifies a method that is mainly used to measure X-ray image enhancement at frequencies close to zero space. The quantum detection efficiency of the device. It focuses on the optoelectronic components of X-ray image intensifiers, rather than the imaging characteristics of the main research in this section. therefore, It is a measure of an optical quantity (brightness) rather than digitized data. In addition, YY/T 0457.5-2003 specifies the components of the radiation source components. Use, and this section specifies the use of X-ray tubes. The scope of YY/T 0457.5-2003 is limited to X-ray image intensifiers, and there is no The scope of this section conflicts. DQE has been widely used by manufacturers to describe the performance of its digital X-ray imaging devices, and the DQE specifications are also regulated by the regulatory agency (eg FDA) as a requirement for an accreditation procedure. However, before the first edition of this section, there is no standard for measurement conditions or measurement procedures. The specification results in data from different sources that are not comparable. This section is developed to regulate the format of the measurement procedures and conformance statements for the quantum detection efficiency (DQE) of digital X-ray imaging devices. In the DQE calculation method recommended in this section, the system response is measured assuming all energy is equalized [5]. The development of this section is beneficial to manufacturers, users, vendors and management. It is the first of three related series of standards file. This part, Part 1-1. Applicable to ordinary photographic detectors, excluding perspective and mammography; Part 1-2. Applicable to mammography detectors; Part 1-3. For detectors for dynamic imaging. 1) The numbers in square brackets are the reference numbers. Characteristics of digital X-ray imaging equipment for medical electrical equipment Part 1-1. Determination of quantum detection efficiency General photography detector

1 Scope

This part of YY/T 0590 specifies the use of air kerma and spatial frequency for operation under the medical conditions specified by the manufacturer. A method of measuring the quantum detection efficiency (DQE) of a digital X-ray imaging apparatus as a function. Target users of this section of YY/T 0590 For manufacturers or well-equipped testing laboratories. Note 1. Although not recommended, for digital X-ray imaging devices integrated in a clinical system, as long as it complies with the setting requirements specified in this section, This section is not excluded to determine its DQE. In addition, you need to pay attention to the following points (for example, but not complete). the establishment of the required radiation quality, the minimum Effects of scatter and backscattered radiation, accurate air kerma measurement, placement of test devices, presence of shields, anti-scatter grids Remove. The scope of this section is limited to digital X-ray imaging devices for single exposure imaging, such as, but not limited to, CR systems, based on straight A system of connected or indirect flat panel detectors. The YY/T 0590 series of standards is not recommended for image intensifier-based X-ray imaging systems. Note 2. This section is not encouraged for use with X-ray image intensifier-based systems. The reason is the low frequency drop, vignetting, and Geometric distortions can severely limit the applicability of the measurement methods described in this section. YY/T 0590 This section does not apply to. digital X-ray imaging devices used in mammography or dental photography; line scan digital X Radiographic imaging device; computed tomography device; dynamic imaging device in which a series of images are acquired, such as perspective and heart Imaging). Note 3. The above equipment is not included in this section because of many of their parameters (such as radiation quality, geometric relationship, time dependence, etc.) and conventional X-ray photography is very different. These technical contents are in other parts of the YY/T 0590 series of standards (YY/T 0590.2 and Handled in YY/T 0590.3).

2 Normative references

The following documents are indispensable for the reference to this document. 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. YY/T 0481-2016 Radiation conditions for the determination of characteristics of medical diagnostic X-ray equipment (IEC 61267.2005, IDT) IEC 60336 medical electrical equipment medical diagnostic X-ray tube assembly focus characteristics (Medicalelectricalequipment-X- raytubeassembliesformedicaldiagnosis-Characteristicsoffocalspots) IEC /T R60788-2004 Medical electrical equipment - Definition of terms (Medicalelectricalequipment-Glossary Ofdefinedterms)

3 Terms and definitions

The following terms and definitions as defined in IEC /T R60788-2004 apply to this document. 3.1 Calibration condition A series of conditions to complete the calibration.

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