YY/T 0658-2008
YY/T 0658-2008 Semi-automated coagulation analyzer
Abstract
This standard specifies the terms and definitions, classification and composition, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage of semi-automatic coagulation analyzers. This standard applies to fully automatic coagulation analyzers used for analyzing coagulation, anticoagulation, fibrinolysis, and anti-fibrinolysis functions in blood. The standard specifies the technical requirements for instruments used to detect plasma prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), and thrombin time (TT). Technical requirements for the detection of coagulation factors and D-dimer are not specified in this standard.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Replaced |
| Standard Code | YY/T 0658-2008 |
| CCS | Medical laboratory equipment |
| ICS | Laboratory medicine |
| Implement Date | 2009-06-01 |