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See Chinese contents: YY/T 1155-2019 YY/T 1155-2019: Automatic luminescence immunoassay analyzer
This standard specifies the requirements, test methods, labels, markings and instructions for use, packaging, transportation, and storage of automatic luminescence immunoassay analyzers. This standard applies to automatic luminescence immunoassay analyzers (hereinafter referred to as analyzers) used in medical laboratories. Analyzers use luminescent systems and immunoassay methods to quantitatively or qualitatively detect various analytes in human serum, plasma, or other body fluids, including luminescence immunoassay analyzers based on chemiluminescence, electrochemiluminescence, fluorescence, and other principles. This standard does not apply to luminescence immunoassay analyzers based on image recognition and automatic luminescence immunoassay analyzers for point-of-care testing (POCT).
