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YY/T 1460-2016Blood rheometer (English PDF)

血液流变仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1460-2016 is the English-translated version of 血液流变仪.

YY/T 1460-2016 is the Chinese pharmaceutical industry standard for the blood rheometer, the instrument that measures the viscosity of blood and plasma at the shear rates of interest in medicine.

It specifies the terms and definitions, the classification, the requirements, the test methods, the marking, the labelling, the instructions and the rules for packaging, transport and storage, covering the measuring range and the accuracy and repeatability of the viscosity, the control of the sample temperature, the shear rate and its accuracy, the carry-over and the electrical safety. Issued on 26 January 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1460-2016

National Standard of the People's Republic of China

ICS: 11.100
Classification: C 44

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
Introduction
1 Scope
2 Normative reference documents
3 Terms and definitions

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

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.

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 document. 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 Blood rheometer

The method of measuring the viscosity of blood or plasma by means of a rotation method, a capillary method or the like.

3.2 Rotary blood rheometer

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 Capillary blood rheometer

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

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

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

Referenced standards

Normative references

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