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YY/T 0310-2025General specifications for X-ray equipment for computed tomography (English PDF)

X射线计算机体层摄影设备通用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 18, 2025

Implementation date

July 1, 2026

Scope

YY/T 0310-2025 is the English-translated version of X射线计算机体层摄影设备通用技术条件.

YY/T 0310 is the general specification for the CT scanner in China, the base document under which the particular standards for specific CT types sit, including YY/T 1625 for mobile CT.

It sets the general technical requirements for X-ray computed tomography equipment and the corresponding test methods, covering the characteristics that define a scanner's performance regardless of where it is installed: image quality, geometric accuracy, dose and the behaviour of the system as a whole.

CT is the highest-dose routine imaging modality and the one where image quality and dose have to be traded off explicitly, which is why the general requirements are revised as the technology moves.

For a manufacturer or an importer of CT systems seeking Chinese registration, this is the standard the type test starts from.

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Document preview — YY/T 0310-2025

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 18 June 2025 by the National Medical Products Administration and takes effect on 1 July 2026.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

1 Scope

YY/T 0310 is the general specification for the CT scanner in China, the base document under which the particular standards for specific CT types sit, including YY/T 1625 for mobile CT. It sets the general technical requirements for X-ray computed tomography equipment and the corresponding test methods, covering the characteristics that define a scanner's performance regardless of where it is installed: image quality, geometric accuracy, dose and the behaviour of the system as a whole. CT is the highest-dose routine imaging modality and the one where image quality and dose have to be traded off explicitly, which is why the general requirements are revised as the technology moves. For a manufacturer or an importer of CT systems seeking Chinese registration, this is the standard the type test starts from.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Cited by

YY/T 0746-2021Particular specifications for medical X-ray equipment installed on vehicles

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