This Standard specifies the terms and definitions, product classification, technical requirements, test methods, labels, marks and instructions for use, packaging, transport and storage of hematology analyzer. This Standard is applicable to the hematology analyzer that analyzes physical components in human blood and provides relative information (hereinafter referred to as the analyzer). This Standard is NOT applicable to the reticulocyte testing.
Basic Data
Standard ID
YY/T 0653-2017 (YY/T0653-2017)
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
14,199
Date of Issue
2017-03-28
Date of Implementation
2018-04-01
Older Standard (superseded by this standard)
YY/T 0653-2008
Regulation (derived from)
China Food and Drug Administration Announcement 2017 No. 38
