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Dynamic digital medical X-ray image detectors
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YY/T 0934-2022
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YY/T 0934-2014 | English | 439 |
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Dynamic digital medical X-ray image detectors
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PDF similar to YY/T 0934-2022
Standard similar to YY/T 0934-2022 YY/T 0933 YY/T 0935 YY/T 0890
Basic data Standard ID | YY/T 0934-2022 (YY/T0934-2022) | Description (Translated English) | Dynamic digital medical X-ray image detectors | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C43 | Word Count Estimation | 15,176 | Issuing agency(ies) | State Drug Administration |
YY/T 0934-2022: Dynamic digital medical X-ray image detectors---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.
Dynamic digital medical X-ray image detectors
ICS 11.040.50
CCSC43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0934-2014
Medical dynamic digital X-ray image detector
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Composition 2
5 Requirements 2
6 Test method 4
Appendix A (Normative) Test Layout 9
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document replaces YY/T 0934-2014 "Medical Dynamic Digital X-ray Image Detector", this document and YY/T 0934-
Compared with.2014, the main technical changes are as follows.
a) Changed the version of some referenced documents in "Normative Reference Documents" to refer to the latest version (see Chapter 2,.2014 edition of
chapter 2);
b) Deleted the term and definition of "dose linear range" (see 3.1 of the.2014 edition);
c) Changed the definitions of "linear dynamic range" and "frame rate" (see 3.7, 3.8, 3.3, 3.4 of the.2014 edition);
d) Added "calibration", "bright field image", "dark field image", "mode", "noise equivalent dose", "additional hysteresis effect" and "proliferative hysteresis effect"
and "Inter-frame grayscale stability" with a total of 8 terms and definitions (see 3.2, 3.3, 3.4, 3.5, 3.6, 3.9, 3.10 and 3.11);
e) Changed the description of "composition" and added embedded software (see Chapter 4, Chapter 4 of the.2014 edition);
f) Deleted "Dose Linear Range" (see 5.4 of the.2014 edition);
g) Added the "image quality" requirement, and included the separate requirements related to image quality under this clause (see 5.4.1, 5.4.2, 5.4.3,
5.4.4, 5.4.5, 5.4.6, 5.4.7, 5.4.8, 5.4.9 and 5.4.10,.2014 editions 5.5, 5.6, 5.7, 5.8, 5.9, 5.10 and
5.11);
h) The test methods of "Noise Equivalent Dose" (see 5.4.1) and "Noise Equivalent Dose" (see 6.4.1) were added;
i) Changed the "Linear dynamic range" (see 5.4.2, 5.5 of the.2014 edition) and the "Linear dynamic range" test method (see 6.4.2,.2014
6.4 and 6.5 of the year edition);
j) Changed the expression requirements of "frame rate" (see 5.4.3, 5.6 of the.2014 edition);
k) Changed "Line pair resolution" to "Spatial resolution" (see 5.4.4, 5.7 of the.2014 edition), changed the "Spatial resolution" test
methods (see 6.4.4, 6.7 of the.2014 edition);
l) Changed the expression of "modulation transfer function" spatial frequency (see 5.4.5, 5.8 of the.2014 edition);
m) Changed the expression of "quantum detection efficiency" spatial frequency (see 5.4.6, 5.9 of the.2014 edition), changed the "quantum detection efficiency"
rate" recording method (see 6.4.6, 6.9 of the.2014 edition);
n) Deleted "afterimage" (see 5.10 of the.2014 edition);
o) Added "Additional Hysteresis Effect" (see 5.4.7) and "Additional Hysteresis Effect" test methods (see 6.4.7);
p) Added the test methods for "proliferation lag effect" (see 5.4.8) and "proliferation lag effect" (see 6.4.8);
q) The test methods of "gray stability between frames" (see 5.4.9) and "gray stability between frames" (see 6.4.9) were added;
r) Changed the serial number of "artifacts" (see 5.4.10, 5.11 of the.2014 edition) and the test method of "artifacts" (see 6.4.10, of the.2014 edition
6.11);
s) Added the verification methods of "communication" (see 5.5) and "communication" (see 6.5);
t) Changed the serial number of "test environment", changed the version of referenced documents and the serial number of intermediate inspection items (see 5.7 and 6.7,.2014
version 5.13 and 6.13);
u) Deleted "Security" (see 5.14 and 6.14 of the.2014 edition);
v) Deleted "Inspection Rules", "Identification, Labeling, Instructions for Use", "Packaging, Transportation and Storage" (see Chapter 7, Section.2014 of the.2014 edition)
Chapters 8 and 9);
w) Added the test layout of Appendix A (see Appendix A).
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical X-ray Equipment and Appliances Sub-Technical Committee (SAC/TC10/
SC1) focal point.
This document was drafted by. Shanghai Yirui Optoelectronics Technology Co., Ltd., Shanghai Pinzhen Imaging Technology Co., Ltd., Shenzhen Shentu Medical
Xue Imaging Equipment Co., Ltd., Liaoning Medical Device Inspection and Testing Institute, Beijing Wandong Medical Technology Co., Ltd.
The main drafters of this document. Zhang Nan, Li Yixin, Rao Yuming, He Shanshan, Tao Yuheng, Fan Xiaomin.
The previous versions of the documents replaced by this document are as follows.
---YY/T 0934-2014.
Medical dynamic digital X-ray image detector
1 Scope
This document specifies the terms and definitions, composition, requirements and
experiment method.
This document applies to medical dynamic digital X-ray image detectors.
This document does not apply to.
--- detectors for dental photography;
--- Image intensifier imaging system.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 10149 Terms and Symbols of Medical X-ray Equipment
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY/T 0481-2016 Radiation conditions for the determination of characteristics of medical diagnostic X-ray equipment
YY/T 0590.3 Characteristics of Digital X-ray Imaging Devices for Medical Electrical Equipment Part 1-3.Determination of Quantum Detection Efficiency
Detector for state imaging
3 Terms and Definitions
The terms and definitions defined in GB/T 10149, YY/T 0481-2016 and YY/T 0590.3 and the following terms and definitions apply to this document.
3.1
After spatial sampling of the images produced by X-ray fluoroscopy and serial photography, the image information in the form of photons is converted into digital in real time
A converter of image information in electronic form.
3.2
calibration
The detector performs some processing necessary to make the image meet the needs of the evaluation, such as background correction, gain correction, and bad pixels
Correction, etc., these processing should be linear and independent of the image.
3.3
brightfield imagebrightimage
Raw X-ray exposure image without background, gain, and bad pixel corrections.
3.4
darkfield image darkimage
Raw unexposed image without background, gain, and bad pixel corrections.
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