YY/T 0590.2-2010Medical electrical equipment—Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency—Detectors used in mammography (English PDF)

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.

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.

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.

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.