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YY/T 1488-2025: Traditional Chinese medical device - Tongue features acquisition device
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YY/T 1488: Evolution and historical versions
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Traditional Chinese medical device - Tongue features acquisition device
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| YY/T 1488-2016 | English | 239 |
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Standard similar to YY/T 1488-2025
YY 0950 | YY/T 1095 | YY 0900 | YY/T 1490 | YY/T 1489 | Basic data
| Standard ID | YY/T 1488-2025 (YY/T1488-2025) |
| Description (Translated English) | Traditional Chinese medical device - Tongue features acquisition device |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C42 |
| Classification of International Standard | 11.040.60 |
| Word Count Estimation | 14,125 |
| Date of Issue | 2025-06-18 |
| Date of Implementation | 2026-07-01 |
| Older Standard (superseded by this standard) | YY/T 1488-2016 |
| Issuing agency(ies) | National Medical Products Administration |
| Summary | This standard specifies the requirements for tongue image information acquisition equipment and describes the corresponding test methods. This document applies to tongue image information acquisition equipment. |
YY/T 1488-2025: Traditional Chinese medical device - Tongue features acquisition device
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ICS 11.040.60
CCSC42
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 1488-2016
Traditional Chinese Medicine Medical Devices for Tongue Image Information Acquisition
Published on 2025-06-18
Implemented on July 1, 2026
National Medical Products Administration issued
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 replaces YY/T 1488-2016 "Tongue Image Information Acquisition Equipment". Compared with YY/T 1488-2016, the only changes are structural adjustments and rewriting.
Aside from the logical changes, the main technical changes are as follows.
---The description of the scope (see Chapter 1, Chapter 1 of the.2016 edition) has been changed;
---Working conditions have been removed (see 4.1 in the.2016 version);
---Requirements and test methods for special spectra have been added (see 4.1.4 and 5.1.4);
---The requirements and test methods for irradiance have been revised (see 4.1.5, 5.1.5, and 4.2.4 and 5.4 in the.2016 version);
---The requirements and test methods for ultraviolet radiation irradiance have been revised (see 4.1.6, 5.1.6, and 4.2.5 and 5.5 in the.2016 version);
---The structural requirements have been changed (see 4.3, 4.4 in the.2016 version);
---The functional requirements and testing methods have been changed (see 4.4, 5.4, and 4.5 and 5.10 in the.2016 version);
---Added requirements for output information and test methods (see 4.5, 5.5);
---The requirements and test methods for biocompatibility have been removed (see sections 4.6 and 5.11 in the.2016 edition);
---The requirements for the instruction manual have been changed (see 4.6, 4.7 of the.2016 version);
---The requirements for inspection rules, markings, labels, instructions for use, packaging, transportation, and storage have been removed (see Chapter 6, Section 1 of the.2016 edition).
Chapters 7 and 8).
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 is under the jurisdiction of the Standardization Technical Unit for Traditional Chinese Medicine Instruments (SMD/T U008).
This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Daosheng Medical Technology Co., Ltd., and Shanghai University of Traditional Chinese Medicine.
Affiliated Shuguang Hospital of Xi'an Medical University, China National Institutes for Food and Drug Control, Yimai Artificial Intelligence Medical Technology (Tianjin) Co., Ltd., Shaanxi Provincial Food and Drug Administration
Inspection and Testing Institute.
The main drafters of this document are. Qian Xuebo, Wang Ying, Zhang Longfei, Qiao Jiaqi, Dai Yunqi, Dai Xuchen, Li Jian, Chen Cheng, Zhou Huilin, and Xu Xiaoting.
Li Shu, Zhou Peng, Cai Hu.
The release history of this document and the document it replaces is as follows.
---First released in.2016 as YY/T 1488-2016;
---This is the first revision.
Traditional Chinese Medicine Medical Devices for Tongue Image Information Acquisition
1.Scope
This document specifies the requirements for tongue image information acquisition equipment (hereinafter referred to as "equipment") and describes the corresponding test methods.
This document applies to tongue image information acquisition 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 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/T 14710 Environmental requirements and test methods for medical electrical appliances
YY 9706.102 Medical Electrical Equipment - Part 1-2.General Requirements for Basic Safety and Basic Performance (Parallel Standard. Electromagnetic Compatibility)
Requirements and Tests
3.Terms and Definitions
The following terms and definitions apply to this document.
3.1
Tongue images are acquired through an imaging device [digital camera or image sensor], and then stored, compared, and analyzed to achieve the desired results.
Devices that provide auxiliary diagnostic information about tongue appearance.
3.2
A light source used to provide the lighting environment required for the operation of equipment.
Note. Hereinafter referred to as "light source".
3.3
resolution
The minimum interval between two adjacent lines that can be identified.
3.4
Color reproduction
The ability of an imaging device to accurately reproduce the colors of the photographed object.
3.5
distortion
The distortion of the image pair caused by the inconsistency between the magnification in the central region and the magnification at the edges is usually manifested as absolute distortion or relative distortion.
To express.
Note. Distortion mainly refers to a series of factors including optical distortion caused by optical lenses, mechanical errors, electrical errors, and display errors of display devices.
The total distortion is represented by the radial distortion component. During imaging and display, the radial distortion component plays a major role, while the tangential distortion component and the radial distortion component...
