YY/T 1489-2016Pulse graph acquisition device for traditional chinese medicine (English PDF)
中医脉图采集设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1489-2016 is the English-translated version of 中医脉图采集设备.
YY/T 1489-2016 is the Chinese pharmaceutical industry standard for the pulse graph acquisition device used in traditional Chinese medicine, the instrument that records the pulse wave at the wrist.
It specifies the terminology and definitions, the requirements, the test methods, the inspection rules, the signs and the rules for packaging, transport and storage, covering the pressure sensor and the range and accuracy of the pressure applied, the frequency response and the noise of the recording channel, the sampling and the display of the pulse graph, and the electrical safety. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1489-2016
National Standard of the People's Republic of China
- Classification
- C 42
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 requirements
- 5 Test methods
- 6 inspection rules
- 7 logo, label, instruction manual
- 8 Packaging, transportation and storage
- Appendix A (informative) General guidance
- Appendix B (informative) Mechanical quantity generator Reference
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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 Pulse graph acquisition device
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191-2008Graphical symbols marking for handling and storage of packages
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.15-2008Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
- GB/T 16886.1-2011Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY 0505-2012Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
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Related Standards
GB 9706.15-2008 — Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
YY 0505-2012 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1489-2016
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