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YY/T 1489-2016 English PDF

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YY/T 1489-2016: Pulse graph acquisition device for traditional chinese medicine
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Standard similar to YY/T 1489-2016

YY 0950   YY/T 1095   YY 0900   YY/T 1490   YY/T 1488   

Basic data

Standard ID YY/T 1489-2016 (YY/T1489-2016)
Description (Translated English) Pulse graph acquisition device for traditional chinese medicine
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C42
Word Count Estimation 15,193
Date of Issue 2016-07-29
Date of Implementation 2017-06-01
Quoted Standard GB/T 191-2008; GB 9706.1-2007; GB 9706.15-2008; GB/T 14710-2009; GB/T 16886.1-2011; YY/T 0466.1-2009; YY 0505-2012
Regulation (derived from) State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the terminology and definitions, requirements, test methods, inspection rules, and marking, packaging, transportation and storage of Chinese medicine pulse pattern collection equipment. This standard applies to the provisions of the provisions of the Chinese medicine pulse pattern acquisition equipment (hereinafter referred to as equipment). This standard does not apply to the analysis of post-harvest data and auxiliary diagnosis.

YY/T 1489-2016: Pulse graph acquisition device for traditional chinese medicine

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Pulse graph acquisition device for traditional chinese medicine ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standard Chinese medicine pulse map 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 7 8 Packaging, transportation and storage 8 Appendix A (informative) General guidance 9 Appendix B (informative) Mechanical quantity generator Reference 12

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, Shanghai Road Health Medical Technology Co., Ltd. The main drafters of this standard. Takayama, Qi Meijing, Zhang Haiming, Zhou Huilin, Zhang Yun, Qian Xuebo. Chinese medicine pulse map collection equipment

1 Scope

This standard specifies the terminology and definitions, requirements, test methods, inspection rules, and signs, packaging, transport and Storage. This standard applies to the provisions of the provisions of the Chinese medicine pulse pattern acquisition equipment (hereinafter referred to as equipment). This standard does not apply to the analysis of post-harvest data and supplementary diagnosis.

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) 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 Through the skin table on the radial artery and the surrounding tissue wrist, off, foot parts in a non-invasive way, in the external force under the conditions of pulse diagram Collected equipment. 3.2 Veins pulsegraph The plot of the applied force and the pulse pressure versus time recorded by the pressure sensor is called the pulse pattern. 3.3 Externally applied force applied A device for applying an applied force to the radial artery. To load can be divided into non-automatic loading and automatic loading, automatic loading is divided into electricity Dynamic loading and pneumatic loading.

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