YY/T 1307-2024 English PDF

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YY/T 1307-2024: Medical digital X-ray image detector used in mammography
Status: Valid

YY/T 1307: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1307-2024	529	Add to Cart	5 days	Medical digital X-ray image detector used in mammography	Valid
YY/T 1307-2016	419	Add to Cart	4 days	Medical digital X-ray image detector used in mammography	Valid

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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Older Standard (superseded by this standard): YY/T 1307-2016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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