YY/T 0659-2017 Translated English of Chinese Standard. YY/T0659-2017: Blood coagulation analyzerhttps://www.chinesestandard.net, 10 aug. 2018 - 15 sidor 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 patient blood. This Standard does not apply to the instruments for platelet aggregation function testing, hemorheological function testing and point-of-care testing. |
Innehåll
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Scope | 5 |
Terms and definitions | 6 |
Product classification | 8 |
Test methods | 10 |
Labelling marking and instructions for use | 14 |
Packaging transportation and storage | 15 |
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5.0 sample requirement Abnormal sample PT accordance with Formula accuracy applicable clauses applicable to full-automated applicable to semi-automated arithmetic mean value Beijing Blood coagulation analyzer calculate the mean carry out testing changes the requirements Channel difference applicable classification Semi-automated clauses of GB/T coagulation tests Item coefficient of variation Continuous working hours continuously after mixing control and laboratory deviation not exceeding different coagulation tests electrical equipment Electromagnetic compatibility equipment for measurement FIB or TT fibrinogen full-automated analyzers hemorheological function testing high-concentration clinical sample low-concentration clinical sample mean value measured measured values Normative references Particular requirements plasma for three platelet aggregation function Preheating PT or APTT rate of FIB reagents Relative deviation reporting unit requirements for electrical requirements GB/T requirements Item name Safety requirements standard deviation steps of instruments terms and definitions test continuously test method test the PT testing and point-of-care testing for three throughput rate vitro diagnostic IVD YY/T