YY/T 1488: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1488-2025 | English | RFQ |
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(Traditional Chinese Medicine Equipment - Tongue information collection equipment)
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YY/T 1488-2025
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| YY/T 1488-2016 | English | 239 |
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Tongue features acquisition device
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YY/T 1488-2016
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Basic data | Standard ID | YY/T 1488-2025 (YY/T1488-2025) | | Description (Translated English) | (Traditional Chinese Medicine Equipment - Tongue information collection equipment) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2026-07-01 | | Older Standard (superseded by this standard) | YY/T 1488-2016 | | Issuing agency(ies) | National Medical Products Administration | YY/T 1488-2016: Tongue features acquisition device---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Tongue features acquisition device
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Tongue information collection equipment
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 requirements 2
5 Test methods 3
6 inspection rules 6
7 logo, label, instruction manual 6
8 Packaging, transportation and storage 8
Appendix A (normative appendix) Spectral weighting function for evaluating UV hazards 9
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Electrical Apparatus Standardization Technical Committee of Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) centralized.
The drafting of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Tianjin University of Traditional Chinese Medicine, Shanghai Dawson Medical Technology Co., Ltd.
the company.
The main drafters of this standard. Qian Xuebo, Qi Ruijing, Gao Shan, Zhang Haiming, Zhang Yun, Lu Xiaozuo, Zhou Huilin.
Tongue information collection equipment
1 Scope
This standard specifies the terminology and definition, requirements, test methods, inspection rules, signs, labels, instructions for the use of tongue-like information collection equipment
Book, packaging, transportation and storage.
This standard applies to the tongue information collection equipment (hereinafter referred to as "equipment") as specified in 3.1.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191-2008 Packaging and storage icon (ISO 780..1997, MOD)
Evaluation method of color rendering of light source GB/T 5702-2003
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety
(IEC 60601-1-1..2000, IDT)
Environmental requirements and test methods for medical appliances GB/T 14710-2009
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management
(ISO 10993-1..2009, IDT)
Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009
(ISO 15223-1..2007, IDT)
YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests
(IEC 60601-1-2..2004, IDT)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
The tongue image is acquired by an imaging device [digital (digital) camera or image sensor], and the tongue image is stored, compared, analyzed
To obtain the auxiliary diagnostic information needed for the tongue of the device.
3.2
Artificial light source
(Hereinafter referred to as "light source") for providing the lighting environment required for the operation of the equipment.
3.3
Resolution resolution
The minimum interval at which the adjacent two lines can be identified is expressed in pairs per millimeter (lp/mm).
3.4
Color reduction colourrevent
The ability of the imaging device to actually reproduce the color of the subject.
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