YY/T 1155-2009: Translated English of Chinese Standard. (YYT 1155-2009, YY/T1155-2009, YYT1155-2009): Automatic Luminescence Immunoassay Analyzer
https://www.chinesestandard.net, 2015. 2. 5. - 11페이지
This Standard specifies the requirements, test methods, marks, labels and instructions, packaging, transportation, and storage of automatic luminescence immunoassay analyzer. This Standard applies to automatic luminescence immunoassay analyzer. The Analyzer uses luminescent system and immunological analyzing method to set and qualitatively detect human blood serum, plasma or other body fluids in a variety of analytes, including luminescent immunoassay analyzers based on principle of chemiluminescence, electrochemical luminescence, fluorescence, etc.
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Marks labels and instructions
Packaging transportation and storage
4th sample 6th sample 8th hour According to Equation Accuracy and fluctuation Analyzer is turned analyzer It refers Analyzer to test automatic luminescence immunoassay CALCULATE the mean calibration products specified Carryover contamination rate China climatic environment test clinical test items correlation coefficient corresponding normal value documents so quoted environmental test Ex-factory serial number fluctuation degree fresh patient samples high concentration sample instrument shall mark item calibration products labels and instructions Linear correlation linear lower-limit sample linear regression linear upper-limit sample luminescence immunoassay analyzer luminescent system magnitude-levels Main functions manufacturing enterprise mean value measured values Measurement repeatability within-batch measurement results mechanical environment test Medical Device Outer marks products and reagents reagents of clinical REPEAT the test requirements of GB Safety requirements samples of corresponding specify the clinical Standard Temperature accuracy test in GB/T test methods test shall comply testing item calibration value or fresh Within-batch measurement repeatability yyxx zero concentration sample Zhang