YY/T 0658-2008
Semi-automated coagulation analyzer (English Version)
- Standard No.
- YY/T 0658-2008
- Language
- Chinese, Available in English version
- Release Date
- 2008
- Published By
- Professional Standard - Medicine
- Status
- 2018-04
- Replace By
- YY/T 0659-2017
- Latest
- YY/T 0659-2017
- Scope
- This standard specifies the terms and definitions, classification and composition, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of semi-automatic coagulation analyzers. This standard applies to fully automatic coagulation analyzers that perform coagulation, anticoagulation, fibrinolysis and antifibrinolysis function analysis on blood. This 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). It is used for coagulation factors, The technical requirements for D-dimer and other tests are not specified in this standard.
YY/T 0658-2008 Referenced Document
- GB 4793.1 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
- GB/T 14710 Enviromental requirement and test methods for medical electrical equipment*， 2009-11-15 Update
- GB/T 191 Packaging.Pictorial marking for handling of goods
- YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
- YY 0648-2008 Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD）medical equipment
YY/T 0658-2008 history
- 2018 YY/T 0659-2017 coagulation analyzer
- 2008 YY/T 0658-2008 Semi-automated coagulation analyzer
YY/T 0658-2008 Semi-automated coagulation analyzer was changed to YY/T 0659-2017 coagulation analyzer.
