YY/T 1959-2025Particular specifications for digital intraoral X-ray imaging system (English PDF)
口腔内数字化X射线成像系统专用技术条件
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 18, 2025
Implementation date
July 1, 2026
Scope
YY/T 1959-2025 is the English-translated version of 口腔内数字化X射线成像系统专用技术条件.
YY/T 1959-2025 is the Chinese standard "Particular specifications for digital intraoral X-ray imaging system". Its scope clause reads: This document defines the terminology and definitions of intraoral digital X-ray imaging systems (hereinafter referred to as imaging systems), and specifies their classification and grouping.
The requirements and corresponding experimental methods are described. This document applies to imaging systems that use digital X-ray detectors with single-exposure imaging capabilities.
This document does not apply to. ---Intraoral imaging using film or light-excited phosphorescent imaging plates as X-ray receivers; ---Extraoral X-ray imaging system. Its clauses include terms and definitions.
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Document preview — YY/T 1959-2025
National Standard of the People's Republic of China
- ICS
- 11.040.50
- Classification
- C43
Issued by: National Medical Products Administration
Contents
- Preface
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4.Classification and Composition
- 5 Requirements
- 6.Test Methods
- Appendix A (Informative) Contrast Detail Phantom
- Appendix B (Informative) Aluminum Ladder Wedge Model
- Appendix C (Informative) Test Layout
1 Scope
This document defines the terminology and definitions of intraoral digital X-ray imaging systems (hereinafter referred to as imaging systems), and specifies their classification and grouping.
The requirements and corresponding experimental methods are described.
This document applies to imaging systems that use digital X-ray detectors with single-exposure imaging capabilities.
This document does not apply to.
---Intraoral imaging using film or light-excited phosphorescent imaging plates as X-ray receivers;
---Extraoral X-ray imaging system.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB 9706.1 Medical electrical equipment - Part 1.General requirements for basic safety and basic performance
GB 9706.265 Medical electrical equipment – Part 2-65.Basic safety and basic performance of intraoral imaging dental X-ray machines
Require
GB/T 10149 Terminology and Symbols for Medical X-ray Equipment
YY/T 0291 Environmental Requirements and Test Methods for Medical X-ray Equipment
YY 9706.102 Medical Electrical Equipment - Part 1-2.General Requirements for Basic Safety and Basic Performance (Parallel Standard). Electromagnetic Compatibility
Tolerance requirements and tests
3 Terms and Definitions
The terms and definitions defined in GB 9706.1, GB 9706.265, GB/T 10149, and YY 9706.102, as well as the following terms and definitions, apply to this document.
3.1 Digital intraoral X-ray imaging system
It typically consists of an image receiver that uses a digital X-ray detector as the intraoral X-ray imaging system and system software, which transmits X-rays through the dental arch.
After the X-rays are converted into digital signals, they are transmitted to the image acquisition and control software via wired data transmission cables or wireless data transmission modules.
Generate digital images.
Note. The system software supports image display, image processing, and image storage functions.
3.2 Digital X-ray detector
After spatial sampling of X-rays using a matrix pixel structure, the X-ray photon signal is converted into digital electronic form.
The signal converter for image information.
3.3 Effective imaging area
The maximum effective area imaged by the detector.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.265Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
- GB/T 10149Terminology and symbol for medical X-ray equipment
- YY/T 0291Environmental requirements and test methods for medical X-ray equipment
- YY 9706.102Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
GB 9706.12-1997 — Medical electrical equipment Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
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