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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.

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