YY/T 1792-2021 Active Industry standards-Medicine

YY/T 1792-2021 Fluorescence immunochromatography analyzer

YY/T 1792-2021 Fluorescence immunochromatography analyzer

Publish Date: 2021-09-06 Implement Date: 2023-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1792-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-09-06

Implement Date: 2023-03-01

Pages: 9 pages

Scope

This standard specifies the requirements, test methods, labels and user manuals, packaging, transportation, and storage for fluorescence immunoassay analyzers. This standard applies to fluorescence immunoassay analyzers (hereinafter referred to as analyzers) used for quantitative analysis of analytes in human samples. The analyzer is used in conjunction with immunoassay reagent cards labeled with fluorescent substances. By measuring the fluorescence intensity of the reaction zone stripes, the analyzer quantitatively analyzes the analytes in human samples. This standard does not apply to instruments used to detect immunoassay reagent cards labeled with colloidal gold or other labeling methods.

Development Information

Word Count: 16 Thousand words Pages: 9 pages

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB 4793.9-2013 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 9:Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use YY 0648-2008 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 191-2025 Graphical symbols marking for handling and storage of packages YY/T 0648-2025 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD)medical equipment

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