YY/T 1155-2019: Automatic luminescence immunoassay analyzer

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Scope

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).

Basic Data

Standard ID	YY/T 1155-2019 (YY/T1155-2019)
Description (Translated English)	Automatic luminescence immunoassay analyzer
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	14,170
Date of Issue	2019
Date of Implementation	2020-06-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the requirements, test methods, labeling, marking and instructions for use, packaging, transportation and storage of fully automatic luminescence immunoassay analyzers. This standard applies to automatic luminescence immunoassay analyzers (hereinafter referred to as analyzers) used in medical laboratories. The analyzer adopts luminescence system and immunoassay method to quantitatively or qualitatively detect various analytes in human serum, plasma or other body fluids, including luminescence immunoassay analyzers based on the principles of chemiluminescence, electrochemiluminescence, and fluorescence. This standard does not apply to: luminescence immunoassay analyzer based on image recognition; automatic luminescence immunoassay analyzer for point-of-care testing (POCT).