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Basic data
| Standard ID | YY/T 0310-2025 (YY/T0310-2025) |
| Description (Translated English) | General specifications for X-ray equipment for computed tomography |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C43 |
| Classification of International Standard | 11.040.50 |
| Word Count Estimation | 13,160 |
| Date of Issue | 2025-06-18 |
| Date of Implementation | 2026-07-01 |
| Older Standard (superseded by this standard) | YY/T 0310-2015, YY/T 1417-2016 |
| Issuing agency(ies) | National Medical Products Administration |
| Summary | This standard specifies the composition and requirements of X-ray computed tomography (CT) equipment and describes the corresponding test methods. This document applies to CT scanning equipment, including CT scanning equipment that provides image data for radiotherapy planning. |
YY/T 0310-2025: General specifications for X-ray equipment for computed tomography
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ICS 11.040.50
CCSC43
Pharmaceutical Industry Standards of the People's Republic of China
Replace YY/T 0310-2015, YY/T 1417-2016
General Technical Requirements for X-ray Computed Tomography Equipment
Published on 2025-06-18
Implemented on July 1, 2026
National Medical Products Administration issued
Table of contents
Preface III
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4 Components 1
5 Requirements 2
6.Test Methods 5
Appendix A (Informative) Typical CT Operating Conditions in Imaging Performance Evaluation Tests 8
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 0310-2015 "General Technical Conditions for X-ray Computed Tomography Equipment" and YY/T 1417-2016.
Technical Requirements for 64-Slice Spiral X-ray Computed Tomography Equipment. This document differs from YY/T 0310-2015 except for structural adjustments and...
Aside from editorial changes, the main technical changes are as follows.
a) Categories (see 4.1 in the.2015 edition), operating noise (see 5.2.6 in the.2015 edition), and high-voltage cable plugs and sockets (see...) have been removed.
(See section 5.5.4 of the.2015 edition), appearance (see section 5.8 of the.2015 edition), and environmental testing (see section 5.9 of the.2015 edition);
b) Increased the number of image scanning layers (see 5.2.9), dose (see 5.3), pitch factor (see 5.4.6), and continuous helical scanning distance (see 5.4.6).
5.4.7), dual-energy imaging (see 5.5), iterative reconstruction (see 5.6), and combined use with external devices (see 5.8);
c) The composition has been changed (see Chapter 4, 4.2 of the.2015 edition);
d) Working conditions have been changed (see 5.1,.2015 version 5.1);
e) Descriptions and requirements for typical CT operating conditions have been added, and imaging performance requirements are based on typical CT operating conditions (see 5.2.1);
f) The image noise (see 5.2.1 in the.2015 version) was changed to noise amplitude (see 5.2.2), and the requirements were modified;
g) Change the slice thickness (see 5.2.8 in the.2015 edition) to the reconstructed slice thickness (see 5.2.7);
h) Increased accuracy requirements for the scanning gantry when used for patient positioning (see 5.4.1);
i) Change the exposure time (see 5.5.3 in the.2015 version) to the load time (see 5.4.5);
j) The requirements and testing methods for radiotherapy planning (RTP) have been changed (see 5.9, 5.7 in the.2015 edition);
k) Security requirements have been changed (see 5.10,.2015 version of 5.10).
Compared with YY/T 1417-2016, the main technical changes in this document are as follows.
---The technical requirements for a 64-slice spiral X-ray computed tomography device are covered by general technical requirements.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document was prepared by the Subcommittee on Medical X-ray Equipment and Instruments of the National Technical Committee on Standardization of Medical Electrical Appliances (SAC/TC10/
SC1) is under the jurisdiction of the relevant authorities.
This document was drafted by. Liaoning Provincial Institute for Medical Device Testing and Inspection, Siemens Medical Devices Co., Ltd. (Shanghai), and United Imaging Healthcare Co., Ltd. (Shanghai).
Joint-stock companies, GE Healthcare Systems Co., Ltd., Neusoft Medical Systems Co., Ltd., Philips Healthcare (Suzhou) Co., Ltd.
The company, Mingfeng Medical Systems Co., Ltd., and Beijing Futong Kangying Technology Co., Ltd.
The main drafters of this document are. Sun Zhiyong, Wang Jianjun, Ye Shuoqi, Tian Yi, Zhou Pei, Wei Dong, Liang Tiecheng, Liu Pu, He Xiujian, and Xu Yifei.
Xing Zhanfeng, Li Xiang, Liu Feiyan, Jiang Nan, Li Huanwen, Qu Yan, Sun Peng.
The release history of this document and the document it replaces is as follows.
---First released in.1998 as YY 0310-1998, and first revised in.2005;
---The second revision in.2015 was YY/T 0310-2015;
This is the third revision;
YY/T 1417-2016 was first released in.2016.This revision, YY/T 0310, covers the 64-layer spiral X-ray computed tomography system.
The technical requirements for computed tomography equipment are covered by the general technical requirements for computed tomography equipment.
General Technical Requirements for X-ray Computed Tomography Equipment
1 Scope
This document specifies the composition and requirements of X-ray computed tomography (CT) equipment (hereinafter referred to as CT scanning equipment), and describes the corresponding test...
Verification method.
This document applies to CT scanning devices, including those that provide image data for radiotherapy planning.
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 9706.228 Medical electrical equipment – Part 2-28.Basic safety and basic performance of medical diagnostic X-ray tube assemblies
Require
GB 9706.103 Medical Electrical Equipment - Part 1-3.General Requirements for Basic Safety and Basic Performance (Parallel Standard). Diagnostic X
Radiation protection for X-ray equipment
GB 9706.244-2020 Medical Electrical Equipment – Part 2-44.Basic Safety and Basic Specifications of X-ray Computed Tomography Equipment
This performance requirement
GB/T 10149 Terminology and Symbols for Medical X-ray Equipment
GB/T 19042.5-2022 Evaluation and routine testing of medical imaging equipment – Part 3-5.X-ray computed tomography equipment
Imaging performance acceptance test and stability test
YY/T 1766.1-2021 Image Quality Evaluation Methods for X-ray Computed Tomography Equipment - Part 1.Modulation Transfer Function
(MTF) rating
YY/T 1766.2-2021 Image Quality Evaluation Methods for X-ray Computed Tomography Equipment - Part 2.Low Contrast Resolution
LCD Ratio Evaluation
YY/T 1766.3-2023 Image Quality Evaluation Methods for X-ray Computed Tomography Equipment - Part 3.Dual-Energy Imaging and
Energy spectroscopy application performance evaluation
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/T 10149, GB 9706.244-2020, GB/T 19042.5-2022, and YY/T 1766.3 apply to...
This document.
4 components
A CT scanning device mainly consists of the following parts.
...
