YY/T 0653-2017: Translated English of Chinese Standard. YY/T0653-2017: Hematology analyzer
https://www.chinesestandard.net, 10.08.2018 - 18 Seiten
This Standard specifies the terms and definitions, product classification, technical requirements, test methods, labels, marks and instructions for use, packaging, transport and storage of hematology analyzer. This Standard is applicable to the hematology analyzer that analyzes physical components in human blood and provides relative information (hereinafter referred to as the analyzer). This Standard is NOT applicable to the reticulocyte testing.
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Terms and definitions
Labels marks and instructions for use
Annex A normative Five classification test method
according to formula analyzer capable analyzer shall meet analyzer technical requirements analyzer white blood anticoagulated applicable provisions average value basophils blood analyzer blood cell classification blood smear capable of dividing Carryover rate requirements clinical sample concentration of clinical conditions specified Confidence interval calculation confidence range control and laboratory correlation coefficient Dichotomous dividing white blood electrical equipment Electromagnetic compatibility eosinophils equipment for measurement equipment GB/T exceeding Not exceeding Five-classification analyzer white hematology analyzer high concentration instrument method linear deviation linear range low concentration lymphocytes meet the requirements method shall comply modified monocytes neutrophils normal working conditions operating instructions packaging Parameter Testing range Particular requirements product classification product shall prevail provisions of GB/T quality control products rate requirements Parameter red blood cells reference method relative deviation requirements for electrical requirements of Table requirements Parameter Testing Safety requirements Table A.2 terms and definitions test method test result upper limit white blood cell YY/T