YY/T 0653-2008: Hematology analyzer

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Scope

This Standard specifies the terms and definitions, classification, requirements, test
methods, labels and instructions, packaging, transportation and storage of hematology
analyzers.
This Standard applies to hematology analyzers (hereinafter referred to as analyzers),
which qualitatively and quantitatively analyze the tangible components in human blood
and provide relevant information.
This standard does not apply to reticulocyte analyzers.

Basic Data

Standard ID	YY/T 0653-2008 (YY/T0653-2008)
Description (Translated English)	Hematology analyzer
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	12,172
Date of Issue	2008-04-25
Date of Implementation	2009-06-01
Quoted Standard	GB/T 191-2008; GB 4793.1; GB/T 14710; YY 0466-2003
Regulation (derived from)	SFDA [2008] No. 192
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the hematology analyzer terms and definitions, classification, requirements, test methods, labeling and instructions for use, packaging, transportation and storage. This standard applies to visible components of human blood for qualitative and quantitative analysis, and provide relevant information hematology analyzer (hereinafter referred to as the analyzer). This standard does not apply to the reticulocyte analyzer.