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YY/T 1307-2024Medical digital X-ray image detector used in mammography (English PDF)

医用乳腺数字化X射线摄影用探测器

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 8, 2024

Implementation date

July 20, 2025

Scope

YY/T 1307-2024 is the English-translated version of 医用乳腺数字化X射线摄影用探测器.

YY/T 1307-2024 is the Chinese standard "Medical digital X-ray image detector used in mammography". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY/T 1307-2024

National Standard of the People's Republic of China

ICS: 44.10.50
Classification: C43
Replacing: YY/T 1307-2016

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Classification and composition
5 Requirement
6 Test methods
Appendix A (Informative) Breast Imaging Phantom
Appendix B (Informative) Test Layout
Appendix C (Informative) Low-contrast test phantom
Appendix D (Informative) Test Device

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1538|YY/T 1537|YY/T 0935|YY/T 1625|YY/T 1308

Editions of YY/T 1307

Edition	Title	Revision	Status
YY/T 1307-2024	Medical digital X-ray image detector used in mammography	current edition	Current
YY/T 1307-2016	Medical digital X-ray image detector used in mammography	previous edition	In force until 2025-07-20

This page sells the current edition, YY/T 1307-2024. Earlier editions are listed for reference only.

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