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YY/T 1452-2016Dry hematology analyzer(centrifuge method) (English PDF)

干式血液细胞分析仪（离心法）

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1452-2016 is the English-translated version of 干式血液细胞分析仪（离心法）.

YY/T 1452-2016 is the Chinese pharmaceutical industry standard for the dry hematology analyzer working by centrifugation, the instrument that measures the cellular components of human blood in a spun capillary.

It specifies the terms and definitions, the composition, the requirements, the test methods, the signs, the labels, the instruction manual and the rules for packaging, transport and storage, covering the measuring ranges and the accuracy and repeatability of each parameter, the carry-over, the stability of the calibration and the electrical safety. Issued on 26 January 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1452-2016

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
4 Composition

Foreword

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

Introduction

The dry blood cell analyzer is a blood cell component that is mounted in a capillary tube containing a fluorescent reagent and a float by centrifugation Layered, and its cell components for quantitative analysis of the instrument.

This type of instrument is suitable for routine routine examination of blood cells and is not suitable for the diagnosis of blood system diseases. Such instruments are unclear Other methods should be tested. Dry blood cell analyzer (Centrifugation)

1 Scope

This standard specifies the terms and definitions, composition, requirements, test methods, signs, labels, and use of a dry blood cell analyzer (centrifugation) Brochures, packaging, transportation and storage.

This standard is applicable to dry blood cell analyzer (centrifugal method) for quantitative analysis of cellular components in human blood (hereinafter referred to as sub- Instrument).

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

GB 4793.7 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 7. Particular requirements for laboratory centrifuges 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

YY/T 0657 Medical centrifuge

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Dry hematology analyzer (centrifuge method)

The blood cell components contained in the capillary tube containing the fluorescent reagent and the float were stratified by centrifugation and the cell composition Quantitative analysis of the instrument.

4 Composition

The analyzer consists of a dedicated desktop high-speed centrifuge and a reader.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0701-2021|YY/T 0655-2024|GB/T 42754-2023

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