This Standard specifies the terms and definitions, product classification, technical requirements, testing methods, labelling, marking, instructions for use, packaging, transportation and storage for blood coagulation analyzers. This Standard applies to blood coagulation analyzers which are used clinically for the analysis of coagulation-anticoagulation and fibrinolysis-antifibrinolysis of patients’ blood. This Standard does not apply to the instruments for platelet aggregation function testing, hemorheological function testing and point-of-care testing.
Basic Data
Standard ID
YY/T 0659-2017 (YY/T0659-2017)
Description (Translated English)
Blood coagulation analyzer
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
10,194
Date of Issue
2017-03-28
Date of Implementation
2018-04-01
Older Standard (superseded by this standard)
YY/T 0659-2008; YY/T 0658-2008
Regulation (derived from)
China Food and Drug Administration Announcement 2017 No. 38
