YY/T 1155-2009: Automatic Luminescence Immunoassay Analyzer

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Scope

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 (hereinafter
referred to as “the 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.

Basic Data

Standard ID	YY/T 1155-2009 (YY/T1155-2009)
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	8,888
Date of Issue	2009-12-30
Date of Implementation	2011-06-01
Quoted Standard	GB/T 191; GB/T 14710; GB 4793.1-2007; YY 0466-2003
Regulation (derived from)	China Food and Drug Administration Announcement 2009 No.83
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the fully automated immunoassay analyzer requirements, test methods, marking, labeling and brochures, packaging, transport and storage of materials. This standard applies to automated immunoassay analyzer (hereinafter referred to as the analyzer). Analyzer using luminescence immunoassay systems and methods of human serum, plasma or other body fluids of various analytes quantitative and qualitative detection, including those based on chemiluminescence, electrochemiluminescence, such as the principle of fluorescence immunoassay analyzer.