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YY/T 0590.3-2011 English PDF

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YY/T 0590.3-2011: Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-3: Determination of the detective quantum efficiency. Detectors used in dynamic imaging
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Basic data

Standard ID YY/T 0590.3-2011 (YY/T0590.3-2011)
Description (Translated English) Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-3: Determination of the detective quantum efficiency. Detectors used in dynamic imaging
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 27,250
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard YY/T 0063; YY/T 0481-2004; ISO 12232-1998; IEC TR 60788-2004
Adopted Standard IEC 62220-1-3-2008, IDT
Regulation (derived from) State Food and Drug Administration Notice No. 106 of 2011
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements on manufacturers of medical work under the conditions of use to air kerma and spatial frequency as a function of digital X-ray imaging apparatus method for measuring the quantum detection efficiency. The intended users of this part of the manufacturer and well-equipped testing laboratory. This section is used to limit the dynamic image digital X-ray imaging apparatus, such as, but not limited to, directly or indirectly based flat panel detector system. Inappropriate to YY/T 0590 used in this part of the X-ray image intensifier-based digital systems. YY/T 0590 This section does not apply to: use in mammography or dental photography, digital X-ray imaging apparatus, computed tomography equipment, scans the patient's X-ray imaging system.

YY/T 0590.3-2011: Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-3: Determination of the detective quantum efficiency. Detectors used in dynamic imaging



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Medical electrical equipment.Characteristics of digital X-ray imaging devices.Part 1-3. Determination of the detective quantum efficiency.Detectors used in dynamic imaging ICS 11.040.50 C43 People's Republic of China pharmaceutical industry standards Medical electrical equipment - Characteristics of digital X-ray imaging apparatus Part 1-3. Determination of the detective quantum efficiency Dynamic imaging with detector Part 1-3. Determinationofthedetectivequantumefficiency- (IEC 62220-1-3.2008, IDT) Issued on. 2011-12-31 2013-06-01 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 4 4.3 quality of the radiation 4 4.4 Experimental Devices 4 4.5 geometry 4 Irradiation conditions 6 4.6 4.6.1 General Conditions 6 Air ratio of kinetic energy release 4.6.2 Measurement 7 4.6.3 lag effect 7 4.6.4 To obtain the conversion function of irradiation 8 4.6.5 Irradiation for measuring noise power spectrum and the lagged effects of 8 4.6.6 radiation beam in irradiated test devices 9 4.6.7 Overview of all necessary irradiated 9 5 9 unprocessed data correction 6 Determination of the quantum detection efficiency of 10 6.1 DQE (u, v) and the definition of formula 10 6.2 10 parameters for evaluation By the image measuring different parameters 11 6.3 11 6.3.1 Data linearization Noise power spectrum 6.3.2 lag effect after correction (NPS) 11 6.3.3 Determination of the modulation transfer function (MTF) of 13 Format 7 Declaration of Conformity 14 8 Accuracy 14 Determination of Annex A (informative) Hysteresis 15 Annex B (informative) Calculation of input noise power spectrum 17 References 18 Index 20

Foreword

YY/T 0590 "Medical electrical equipment - Characteristics of digital X-ray imaging apparatus" is divided into the following sections. --- Part 1. Determination of the detective quantum efficiency; --- Part 1-2. Determination of the detective quantum efficiency of breast X-ray photography detectors; --- Part 1-3. Determination of dynamic imaging using quantum detection efficiency of the detector. This section YY/T Part of 1-30590. This section drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this section may involve patents, the present document issuing authority does not bear the responsibility to identify these patents. This section uses the translation method identical with IEC 62220-1-3.2008 "Medical electrical equipment - Characteristics of digital X-ray imaging apparatus section Part 1-3. Determination of the detective quantum efficiency with dynamic imaging detectors. " This part made the following editorial changes. --- Remove the IEC foreword; --- Some of the statements apply to international standards to apply to our standard formulation. This part is proposed by the State Food and Drug Administration. 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 section is drafted. Liaoning Medical Device Control, Space Star Space Technology Applications Co., Hang Wei universal health care system Limited, Siemens Shanghai Medical Equipment Co., Ltd. The main drafters of this section. Sun Zhiyong, Zou Yuan, Feng-Chao, Guo Qiang, Shou water.

Introduction

Digital X-ray imaging device is being increasingly widely used in medical diagnostics and gradually replace the traditional screen-film X-ray systems and analog Image intensifier television system. Therefore, it is necessary to define the description of the digital X-ray imaging apparatus imaging performance parameters and the use of specific measurement procedures standard Normalized. In the scientific community is the growing consensus detective quantum efficiency (DQE) is the most appropriate description of the parameters X-ray imaging apparatus imaging performance. DQE describes an image forming apparatus to maintain the ability to output from the radiation field of digital image data signal to noise ratio. In the X-ray imaging, radiation field Noise and air kerma levels are closely related, so DQE values can also be used as a digital X-ray imaging device description given Dose efficiency. Note 1. Although DQE has been widely used to describe the performance of the image forming apparatus, but the relationship of the physical parameters of the behavior of a human observer has not yet determined Completely understood [1], [3] 1). Note 2. YY/T 0457.5-2003 specific description is a method, this approach is mainly used to determine the spatial frequencies close to zero in the X-ray image enhancement The detective quantum efficiency. It focuses on optoelectronic components research X-ray image intensifier, rather than standard main imaging properties of the present. therefore, It is a measure of the amount of an optical (brightness), instead of digitized data. In addition, YY/T 0457.5-2003 specifies the radiation source assembly causes Use, and this standard specifies the use of X-ray tube. Range YY/T 0457.5-2003 is defined in the X-ray image intensifier, and not with The scope of the standard conflict. 1) The numbers in square brackets reference number. DQE is already widely used by the manufacturer to characterize the performance of its digital X-ray imaging apparatus, DQE specification also by management (for example, FDA) as a recognized procedures. However, whether the measurement conditions or the measurement procedure is currently no standard specification, resulting in different Data sources are not comparable. Therefore, the enactment of this section in order to standardize the digital X-ray imaging apparatus detective quantum efficiency measurement procedures and compliance statement format. In the DQE calculation method recommended in this section, the system response is to assume that all the energy is equal attenuation measured [5]. This section would benefit manufacturers, users, vendors, and management. It is a series of three related standards in the third file. Part 1. suitable for X-ray photography, not including breast X-ray photography and fluoroscopy. Part 1-2. suitable for breast X-ray photography. This part is the Part 1-3. suitable for dynamic imaging detector. Described above can be seen as part of a digital X-ray imaging apparatus related parameters YY/T 0590 the first part of series of standards. Medical electrical equipment - Characteristics of digital X-ray imaging apparatus Part 1-3. Determination of the detective quantum efficiency Dynamic imaging with detector

1 Scope

YY/T 0590 This section specifies the use under medical conditions specified by the manufacturer working to release the kinetic energy of air ratio and spatial frequency Determination of the detective quantum efficiency of digital X-ray imaging apparatus function. Expected users of this section is the manufacturer and well-equipped test laboratory. This section limits for dynamic imaging of digital X-ray imaging apparatus, such as, but not limited to, directly or indirectly, based on flat panel detector system. This should not be part of YY/T 0590 is applied based on the X-ray image intensifier digital system. Note 1. The reason why not is based on the phenomenon of low frequency drop and vignetting and geometric distortion phenomenon appears to consider in these devices, these phenomena may be serious Limit measuring method described in this section applicability. YY/T 0590 This section does not apply to. --- Use of digital X-ray imaging apparatus mammography or dental photography; --- Computer tomography equipment; and --- Patient scan imaging X-ray systems; Note 2. Does not include the above-described means, because they contain a lot different than for dynamic imaging very important parameters (for example, radiation quality, geometry, time Dependence, etc.). Some of these parameters in other parts (YY/T 0590.1 and YY/T 0590.2) has been specified.

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. YY/T 0063 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal (YY/T 0063-2007, IEC 60336. 2005, IDT) YY/T 0481-20042) medical diagnostic X-ray equipment with radiation characteristic measurement conditions (IEC 61267.1994, IDT) 2) Although the IEC 61267 2nd edition (2005) has been released, but in order to make the IEC 62220 series of standards conformance, to the first edition (IEC 61267. 1994) is also a special reservation throughout this standard. ISO 12232.1998 Determination of the electronic still photographic images from the camera's ISO speed (Photography-Electronicstil- picturecameras-DeterminationofISO speed) IEC TR60788.2004 Medical electrical equipment defined in the glossary (Medicalelectricalequipment-Glossary ofdefinedterms)

3 Terms and Definitions

IEC 60788 define the following terms and definitions apply to this document.

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