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YY/T 1460-2016 English PDF

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YY/T 1460-2016: Blood rheometer
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Basic data

Standard ID YY/T 1460-2016 (YY/T1460-2016)
Description (Translated English) Blood rheometer
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 12,161
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB/T 191; GB 4793.1; GB/T 14710; GB/T 18268.1; GB/T 18268.26; YY 0648
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the terms and definitions, classification, requirements, test methods, logos, labels and instructions, packaging, transportation and storage of blood rheometers (hereinafter referred to as rheometers).

YY/T 1460-2016: Blood rheometer

---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.
Blood rheometer ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Blood rheometer 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

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 release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting of this standard. Beijing Medical Devices Testing Institute, Beijing Saixi Xi De Technology Development Co., Ltd., Beijing in the world imperial science instrument Co., Ltd., Beijing Municipal Drug Administration Medical Device Technology Review Center, Chongqing Tianhai Medical Equipment Co., Ltd., Beijing Public Chi-wei Technology Development Co., Ltd. The main drafters of this standard. continued Yong, Ding Chonghui, Li Gang, Sun Rong, Lu Guangzhou, Yang Junjing.

Introduction

Hemorheology is mainly medical, health, scientific research and other units for the detection of specific shear rate of blood viscosity of medical equipment, clinical In the thrombosis prevention, treatment and so has a very important significance. At present, there is no national standard and industry standard of blood rheometer, the development of this standard will be the design, production and sales of blood rheometer Sale and use to provide the necessary, unified basis. Currently on the market using the blood viscosity meter, blood rheometer refers to the specific shear rate in the detection of blood viscosity of the instrument. Blood rheometer

1 Scope

This standard specifies the terms and definitions, classification, requirements, test methods, marking, labeling and labeling of blood rheometers (hereinafter referred to as rheometers) With instructions, packaging, transportation and storage.

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 packaging and storage icon GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements Environmental requirements and test methods for medical appliances GB/T GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use - Part 26. Particular requirements Diagnostic (IVD) medical equipment YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment Of the special requirements

3 terms and definitions

The following terms and definitions apply to this document. 3.1 The method of measuring the viscosity of blood or plasma by means of a rotation method, a capillary method or the like. 3.2 So that the blood is in a rotating state, the determination of shear rate corresponding to the apparent viscosity of blood method known as the rotation method, the use of this method to determine blood Liquid viscosity of the instrument called rotary blood rheometer. 3.3 The method of measuring the viscosity of a blood or plasma in a capillary in a diameter capillary is called a capillary method and is measured by this method Blood viscosity of the instrument called capillary blood rheometer. 3.4 Newtonian fluid Newtonianfluid Obey the Newtonian law of viscosity, the viscosity does not change with the shear stress and shear rate changes in the fluid. 3.5 Non-Newtonian fluid non-NewtonianFluid Do not obey Newton's law of viscosity, viscosity changes with the shear stress and shear rate changes in the fluid.

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