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YY/T 1307-2024: Medical digital X-ray image detector used in mammography
Status: Valid YY/T 1307: Evolution and historical versions
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Medical digital X-ray image detector used in mammography
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YY/T 1307-2024
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| YY/T 1307-2016 | English | 419 |
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Medical digital X-ray image detector used in mammography
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YY/T 1307-2016
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PDF similar to YY/T 1307-2024
Basic data | Standard ID | YY/T 1307-2024 (YY/T1307-2024) | | Description (Translated English) | Medical digital X-ray image detector used in mammography | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Classification of International Standard | 44.10.50 | | Word Count Estimation | 26,223 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Older Standard (superseded by this standard) | YY/T 1307-2016 | | Issuing agency(ies) | State Drug Administration | YY/T 1307-2024: Medical digital X-ray image detector used in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.
ICS 44.10.50
CCSC43
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1307-2016
Detectors for medical mammography digital X-ray
Released on 2024-07-08
2025-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and composition 2
5 Requirement 3
6 Test methods 5
Appendix A (Informative) Breast Imaging Phantom 12
Appendix B (Informative) Test Layout 14
Appendix C (Informative) Low-contrast test phantom 16
Appendix D (Informative) Test Device 18
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 for standardization documents"
Drafting.
This document replaces YY/T 1307-2016 "Detectors for Medical Digital Mammography" and is consistent with YY/T 1307-2016.
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) Added "Calibration", "Center Axis", "Original Bright Field Image", "Original Dark Field Image", "Noise Equivalent Dose", "Frame Rate", "Exposure Window"
9 terms and definitions (see 3.1, 3.2, 3.3, 3.4, 3.5, 3.10, 3.11, 3.12)
and 3.13);
b) Changed the definition of “linear dynamic range” (see 3.6, 3.2 of the.2016 edition);
c) The definition of “blind zone” has been changed (see 3.7, 3.3 of the.2016 edition);
d) Added “Classification” (see 4.1);
e) Added “noise equivalent dose” (see 5.4) and “noise equivalent dose” test method (see 6.4);
f) Deleted the “dose linear range” (see 3.1 and 5.4 of the.2016 edition) and the “dose linear range” test method (see
6.4);
g) Changed the “Linear Dynamic Range” (see 5.6, 5.5 of the.2016 version) and the “Linear Dynamic Range” test method (see 6.6,
Version 6.5);
h) Changed the expression of "spatial resolution" (see 5.7, 5.6 of the.2016 edition) and the test method of "spatial resolution"
(See 6.7, 6.6 of the.2016 edition);
i) The expression of “modulation transfer function” has been changed (see 5.8, 5.8 of the.2016 edition);
j) Added the test method of “internal trigger sensor sensitivity” (see 5.14) and “internal trigger sensor sensitivity” (6.14);
k) Added “preview time” (see 5.15) and test method for “preview time” (see 6.15);
l) Added “frame rate” (see 5.16) and “frame rate” test method (see 6.16);
m) The expression of "appearance" has been changed (see 5.17, 5.13 of the.2016 edition);
n) Changed "Power supply conditions" (see 6.1.2, 6.1.2 of the.2016 edition);
o) The test method for “artifacts” has been changed (see 6.13, 6.12 of the.2016 edition);
p) Deleted “Inspection Rules”, “Identification, Labeling, Instructions for Use”, “Packaging, Transportation, Storage” (see Chapter 7, Chapter 8 of the.2016 edition)
and Chapter 9);
q) Deleted “Appendix C (Normative Appendix) Determination of Detector Noise Equivalent Dose” (see Appendix C of the.2016 Edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is prepared by the National Technical Committee for Standardization of Medical Electrical Appliances, Medical X-ray Equipment and Appliances Standardization Subcommittee (SAC/TC
10/SC1) is under the jurisdiction of the relevant competent authority.
This document was drafted by. Liaoning Medical Device Inspection and Testing Institute, Jiangsu Kangzhong Digital Medical Equipment Co., Ltd., Shanghai Yirui Optoelectronics
Technology Co., Ltd., Shanghai Pinzhen Imaging Technology Co., Ltd., and Medical Device Technical Review Center of the State Food and Drug Administration.
The main drafters of this document are. Guo Baijun, Liu Jingbo, Sun Zhiyong, He Shanshan, Liu Jianqiang, Huang Xiping, Li Yixin, Wang Jing, Sun Peng, Zhou Chengguang.
Previous versions of this document and the documents it replaces are.
---First published in.2016 as YY/T 1307-2016;
---This is the first revision.
Detectors for medical digital mammography
1 Scope
This document specifies the classification, composition and requirements of detectors for medical mammography (hereinafter referred to as detectors), and describes the corresponding
test method.
This document applies to detectors used in mammography equipment with single or multiple exposure imaging capabilities, including but not limited to amorphous
Silicon detector, amorphous selenium detector, CCD (charge coupled device) detector, CMOS (complementary metal oxide semiconductor) detector,
IGZO (Indium Gallium Zinc Oxide) detectors, photon counting detectors, etc.
This document does not apply to.
--- Detectors for general photography and detectors for dental photography;
--- Detectors for computed tomography;
---Detector for dynamic imaging.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance
GB/T 10149-1988 Terminology and symbols for medical X-ray equipment
YY/T 0291 Environmental requirements and test methods for medical X-ray equipment
YY/T 0481-2016 Radiation conditions for measuring characteristics of medical diagnostic X-ray equipment
YY/T 0590.2-2010 Characteristics of digital X-ray imaging devices for medical electrical equipment Part 1-2.Quantum detection efficiency
Measuring detectors for mammography
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility
Requirements and tests
3 Terms and definitions
The terms and definitions defined in YY/T 0590.2-2010, GB/T 10149-1988, YY/T 0481-2016 and the following apply
in this document.
3.1
Calibration
The detector performs necessary operations to make the image meet the evaluation requirements. These processes should be linear and independent of the image.
Examples. background correction, gain correction, and bad pixel correction, etc.
3.2
Central axis
A straight line perpendicular to the incident plane and passing through the center of the incident field.
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