YY/T 1160-2021 Active Industry standards-Medicine

YY/T 1160-2021 Carcinoembryonic antigen testing kit

YY/T 1160-2021 Carcinoembryonic antigen testing kit

Publish Date: 2021-12-06 Implement Date: 2022-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1160-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-12-06

Implement Date: 2022-12-01

Pages: 12 pages

Scope

This document specifies the classification, requirements, testing methods, labels and user manuals, packaging, transportation, and storage of cancer embryonic antigen (CEA) assay kits.
This document applies to assay kits that quantitatively determine CEA based on the principle of double antibody sandwich assay, including luminescent immunoassay kits and enzyme-linked immunosorbent assay kits using labeling methods such as chemiluminescence, electrochemiluminescence, and fluorescence.
This document does not apply to various radioimmunoassay or immunoradiometry kits labeled with radioisotopes such as 125I for CEA.

Development Information

Word Count: 16 Thousand words Pages: 12 pages

Replace the following standards

YY/T 1160-2009

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 29791.2-2013 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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