YY/T 1233-2014: Translated English of Chinese Standard. (YYT 1233-2014, YY/T1233-2014, YYT1233-2014): Cardiac troponin-I (cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay) [Tips: BUY here & GET online-reading at GOOGLE. Then, if you need unprotected-PDF for offline-reading, WRITE to Wayne: Sales@ChineseStandard.net]
https://www.chinesestandard.net, 15 févr. 2015 - 11 pages
This Standard specifies the terms and definitions, requirements, test methods, marking, labeling, instructions, packaging, transportation, and storage of cardiac troponin-I (cTnI) quantitative detection reagent (kit) (chemiluminescent immunoassay). This Standard applies to the quantitative detection of human cardiac troponin-I (cTnI) quantitative detection reagent (kit) by the principal of chemiluminescent immunoassay, including the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers such as microplates, tubes, and magnetic particles. This Standard does not apply to the requirements for the calibrator and control materials in reagent (kit).
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Marks labels and instructions
Packaging transportation and storage
according to formula according to GB/T acute myocardial infarction Analytical specificity average value batches of reagent Between-batch difference blank limit CALCULATE according CALCULATE the average cardiac troponin cardiac troponin-I cTnI certified reference materials chemiluminescent immunoassay coefficient of variation component of reagent critical value cross reactants Cross reaction rate detect a same-sample DETECT the accuracy Document enterprise shall provide expired-sample Explanation of analytical following contents Instructions of reagent items shall meet least the following Limit of blank linear interval measurement results Medical Device meet the requirements perform detection Product lot number Product name quantitative detection reagent reagent kits Recovery test relative deviation requirements of 4.3a requirements of 4.7 results shall meet RLU value sample to perform serum sample Shanghai skeletal troponin solution-A Stability in validity standard deviation SD terms and definitions Test methods Thermal stability test Traceability Manufacturing enterprise traceable assignment process validity period value of acute zero-concentration calibrator