YY/T 1233-2024 Active Industry standards-Medicine

YY/T 1233-2024 Cardiac troponin detection reagent kit(labelling immunoassay)

YY/T 1233-2024 Cardiac troponin detection reagent kit(labelling immunoassay)

Publish Date: 2024-09-29 Implement Date: 2025-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1233-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2024-09-29

Implement Date: 2025-10-15

Pages: 9 pages

Scope

This document specifies the requirements for myocardial troponin assay kits (labeled immunoassay), including identification, labeling, and user manuals, as well as packaging, transportation, and storage, and describes the corresponding test methods.
This document is applicable to kits used for the quantitative detection of myocardial troponin I (hereinafter referred to as cTnI) and myocardial troponin T (hereinafter referred to as cTnT) in human serum, plasma, or whole blood in vitro. The methods include enzyme-linked immunosorbent assay (ELISA), enzymatic and non-enzymatic chemiluminescence, electrochemiluminescence, and time-resolved fluorescence immunoassay, etc.

Development Information

Word Count: 17 Thousand words Pages: 9 pages

Replace the following standards

YY/T 1233-2014 Cardiac troponin-I(cTnI)quantitative detection reagent(kit)(Chemiluminescent immunoassay)

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/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use GB/T 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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