YY/T 1582-2018: Colloidal gold immunochromatography reader

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Scope

This standard specifies the requirements, test methods, labels and instructions
for use, packaging, transportation and storage of colloidal gold
immunochromatography analyzers.
This standard is applicable to instruments that interpret the results of samples
by measuring the reflectivity of the bands in the reaction zone of the colloidal
gold reagent card (hereinafter referred to as analyzers).
This standard does not apply to instruments that use fluorescent labels or other
labeling methods for rapid immunoassay.

Basic Data

Standard ID	YY/T 1582-2018 (YY/T1582-2018)
Description (Translated English)	Colloidal gold immunochromatography reader
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	13,173
Date of Issue	2018-02-24
Date of Implementation	2019-03-01
Quoted Standard	GB/T 191; GB 4793.1; GB 4793.9; GB/T 14710; GB/T 18268.1; GB/T 18268.26; GB/T 29791.3; YY 0648
Regulation (derived from)	China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the requirements, test methods, labels, and instructions for use, packaging, transportation, and storage of colloidal gold immunochromatographic analyzers. This standard is applicable to instruments that interpret the sample results by measuring the reflectance of the reaction zone of the colloidal gold reagent card (hereinafter referred to as the analyzer). This standard does not apply to instruments that perform rapid immunoassays using fluorescent labels or other labeling methods.