YY/T 1488-2025 English PDFYY/T 1488: Historical versions
Basic dataStandard 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of International Standard: 11.040.60 Date of Issue: 2025-06-18 Date of Implementation: 2026-07-01 Older Standard (superseded by this standard): YY/T 1488-2016 Issuing agency(ies): National Medical Products Administration YY/T 1488-2016: Tongue features acquisition device---This is a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 ForewordThis 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 equipment1 ScopeThis 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 documentsThe 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 definitionsThe 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1488-2025_English be delivered?Answer: Upon your order, we will start to translate YY/T 1488-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1488-2025_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1488-2025_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 1488-2025?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1488-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |