YY/T 0653-2008 Translated English of Chinese Standard (YYT 0653-2008, YY/T0653-2008, YYT0653-2008): Hematology analyzerThis Standard specifies the terms and definitions, classification, requirements, test methods, labels and instructions, packaging, transportation and storage of hematology analyzers. This Standard applies to hematology analyzers (hereinafter referred to as analyzers), which qualitatively and quantitatively analyze the tangible components in human blood and provide relevant information. |
Contents
| 3 | |
Scope | 4 |
Product classification | 6 |
Test methods | 9 |
Labels and instructions | 11 |
Packaging transportation and storage | 13 |
Annex A normative Fiveclassifying test method | 14 |
Bibliography | 17 |
Common terms and phrases
accuracy of white analyze the tangible analyzer shall meet analyzers Parameter Detection Annex A normative anticoagulation applicable clauses Atmospheric pressure automatic hematology analyzer basophils blood cell classification blood smear calibrator Carry-over rate WBC classification for five-classifying clauses in GB CLIA comply concentrated blood cells concentration range Confidence interval worksheet confidence limit confidence range Detection range Precision dilution concentration Environmental test eosinophils five-classifying analyzers GB/T HCT/MCV hematology analyzer capable histogram human blood measurement Instrument comparability Deviation instrument method instrument operating instructions labels and instructions linear quality controls linear range lymphocytes manufacturer’s specifications MEASURE three medical device meet the requirements method shall meet monocytes NCCLS neutrophils number of medical Packaging Parameter Detection range personnel uses blood Precision WBC 4.0 production company’s name range Precision WBC red blood cells reference method requirements for semi-automatic requirements of Table semi-automatic analyzers Standard symbols terms and definitions test method test personnel white blood cell