YY/T 1991-2025Artificial intelligence medical device - Computer assisted analysis software for stroke CT images - Algorithm performance test methods (English PDF)
人工智能医疗器械 脑卒中CT影像辅助分析软件 算法性能测试方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 30, 2025
Implementation date
November 1, 2026
Scope
YY/T 1991-2025 is the English-translated version of 人工智能医疗器械 脑卒中CT影像辅助分析软件 算法性能测试方法.
YY/T 1991-2025 is the Chinese standard "Artificial intelligence medical device - Computer assisted analysis software for stroke CT images - Algorithm performance test methods".
Its scope clause reads: This document describes a testing method for the performance of software algorithms that use artificial intelligence technology to assist in the analysis of CT images of stroke.
This document applies to auxiliary analysis software that uses artificial intelligence technology to post-process CT images of stroke. This document is not applicable to image preprocessing or process optimization software. Its clauses include terms and definitions.
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Document preview — YY/T 1991-2025
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C30
Issued by: National Medical Products Administration
Contents
- Preface
- Introduction
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4.Algorithm performance testing requirements
- 5.Algorithm Performance Testing Methods
- Appendix A (Informative) Supplementary Explanation of Relevant Medical Concepts
- Appendix B (Informative) Example 16 of the Head CT Test Set Description
- Appendix C (Informative) Guidelines and Methodological Instructions for Specific Clauses
- References
1 Scope
This document describes a testing method for the performance of software algorithms that use artificial intelligence technology to assist in the analysis of CT images of stroke.
This document applies to auxiliary analysis software that uses artificial intelligence technology to post-process CT images of stroke.
This document is not applicable to image preprocessing or process optimization software.
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.
YY/T 1833.1 Quality Requirements and Evaluation of Artificial Intelligence Medical Devices Part 1.Terminology
YY/T 1833.2 Quality Requirements and Evaluation of Artificial Intelligence Medical Devices Part 2.General Requirements for Datasets
YY/T 1833.3 Quality Requirements and Evaluation of Artificial Intelligence Medical Devices Part 3.General Requirements for Data Labeling
3 Terms and Definitions
The terms and definitions defined in YY/T 1833.1, YY/T 1833.2, and YY/T 1833.3, as well as the following terms and definitions, apply to this document.
3.1
Images obtained using computed tomography (CT) without the use of any contrast agents.
3.2
Blood samples were obtained by intravenously injecting contrast agent and performing a CT scan at the time point when the contrast agent concentration in the target blood vessel reached its peak.
Enhanced imaging of the pipeline system.
3.3
Following rapid intravenous bolus injection of contrast agent, multiple consecutive CT scans of the brain region of interest were performed to obtain brain perfusion data with time-series information.
Image caption.
Note. Post-processing calculations of time-density curves of brain regions of interest are performed to obtain quantified tissue blood perfusion parameters.
3.4 infarct core
The area of brain tissue death caused by ischemic stroke.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 28 pages — is available in the English PDF.
Referenced standards
Normative references
- YY/T 1833.1Artificial intelligence medical device—Quality requirements and evaluation - Part 1: Terminology
- YY/T 1833.2Artificial intelligence medical device—Quality requirements and evaluation - Part 2: General requirements for datasets
- YY/T 1833.3Artificial intelligence medical device—Quality requirements and evaluation - Part 3: General requirement for data annotation
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Related Standards
YY/T 1833.1-2022 — Artificial intelligence medical device—Quality requirements and evaluation - Part 1: Terminology
YY/T 1833.2-2022 — Artificial intelligence medical device—Quality requirements and evaluation - Part 2: General requirements for datasets
YY/T 1833.3-2022 — Artificial intelligence medical device—Quality requirements and evaluation - Part 3: General requirement for data annotation
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