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YY/T 1625-2026Particular specifications for mobile X-ray equipment for computed tomography (English PDF)

移动式X射线计算机体层摄影设备专用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 9, 2026

Implementation date

March 1, 2027

Scope

YY/T 1625-2026 is the English-translated version of 移动式X射线计算机体层摄影设备专用技术条件.

YY/T 1625 is the particular specification for the CT scanner that comes to the patient. It specifies the composition and the requirements of mobile X-ray computed tomography equipment, referred to throughout as the mobile CT scanning device, and describes the corresponding test methods. A CT that is wheeled into an intensive care unit or a stroke ward has constraints a fixed installation does not: it has to hold image quality while being moved, and it has to manage radiation in a room that was never designed as a scanner suite. The standard applies to mobile CT devices and excludes equipment outside that definition. For a manufacturer or an importer of mobile or portable CT systems seeking Chinese registration, this is the particular standard the type test is run against, on top of the general medical electrical requirements.

Document preview — YY/T 1625-2026

National Standard of the People's Republic of China

ICS
11.040.50
Classification
C43
Replacing
YY/T 1625- 2018

Issued by: National Medical Products Administration

Contents

  • 1.Scope1
  • 2 Normative References1
  • 3.Terms and Definitions 1 4 components2
  • 5 Requirements2
  • 5.1 Working Conditions2
  • 5.2 Imaging Performance2
  • 5.3 Dosage and Radiation Protection3
  • 5.4 Mechanical and Radiative Output Performance4
  • 5.6 Software Functions5
  • 5.7 Combined use with external devices5
  • 5.8 Safety5
  • 6.2 Imaging Performance6
  • 6.3 Dosage and Radiation Protection7
  • 6.4 Mechanical and Radiative Output Performance7
  • 6.5 Iterative Reconstruction9
  • 6.6 Software Functions9
  • 6.7 Combined use with external devices9
  • 6.8 Safety9

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. This document supersedes YY/T 1625-2018 "Technical Conditions for Mobile X-ray Computed Tomography Equipment" and is consistent with YY/T 1625- Compared to.2018, aside from structural adjustments and editorial changes, the main technical changes are as follows:

a) Categories (see

4.1 in the.2018 edition), operating noise (see

5.2.6 in the.2018 edition), and X-ray generating devices (see.2018 edition) have been removed. Version 5.6), child protocol unit (see

5.10 of the.2018 version), appearance (see

5.11 of the.2018 version), and environmental testing (see.2018 version). (

5.12 of the.2018 edition).

b) Changes were made to the composition (see Chapter 4,

4.2 of the.2018 edition), imaging performance (see

5.2 of the.2018 edition), and mobility performance (see...). 5.4.1 (

5.5 in the.2018 version).

c) Increased general requirements for imaging performance (see 5.2.1), number of image scan layers (see 5.2.9), dose and radiation protection (see 5.3), and machine... Mechanical and radiation output performance (see 5.4), iterative reconstruction (see 5.5), and combined use with external equipment (see 5.7).

d) Security requirements have been changed (see 5.8,

1 Scope

YY/T 1625 is the particular specification for the CT scanner that comes to the patient. It specifies the composition and the requirements of mobile X-ray computed tomography equipment, referred to throughout as the mobile CT scanning device, and describes the corresponding test methods. A CT that is wheeled into an intensive care unit or a stroke ward has constraints a fixed installation does not: it has to hold image quality while being moved, and it has to manage radiation in a room that was never designed as a scanner suite. The standard applies to mobile CT devices and excludes equipment outside that definition. For a manufacturer or an importer of mobile or portable CT systems seeking Chinese registration, this is the particular standard the type test is run against, on top of the general medical electrical requirements.

This document specifies the composition and requirements of mobile X-ray computed tomography equipment (hereinafter referred to as mobile CT scanning device), and describes... The corresponding experimental methods were developed. This document applies to mobile CT scanning devices. This document does not apply to X-ray computed tomography equipment that moves via guide rails or X-ray equipment that is fixedly installed on transportation vehicles. Computed tomography equipment.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are listed below. 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. document.

GB 9706.1 Medical electrical equipment - Part

3 Terms and Definitions

The terms defined in GB/T 10149, GB 9706.244-2020, GB/T 19042.5-2022, and YY/T 1766.3-2023, as well as the following technical terms The terms and definitions apply to this document.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 13 pages — is available in the English PDF.

Referenced standards

Similar standards

YY/T 1711|YY/T 1694|YY/T 1537|YY/T 1973|YY/T 1959

Editions of YY/T 1625

EditionTitleRevisionStatus
YY/T 1625-2026Particular specifications for mobile X-ray equipment for computed tomographycurrent editionCurrent
YY/T 1625- 2018Particular specifications for mobile X-ray equipment for computed tomographyprevious editionIn force until 2027-03-01

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