YY/T 1589-2018 Active Industry standards-Medicine

YY/T 1589-2018 Estradiol testing kit(Chemiluminescent immunoassay)

YY/T 1589-2018 Estradiol testing kit(Chemiluminescent immunoassay)

Publish Date: 2018-04-11 Implement Date: 2019-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1589-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2018-04-11

Implement Date: 2019-05-01

Pages: 7 pages

Scope

This standard specifies the requirements for estrogen determination kits (chemiluminescence immunoassay), including test methods, labeling and user manuals, packaging, transportation, and storage. This standard applies to kits used to determine estrogen based on the principle of chemiluminescence immunoassay. It includes chemiluminescence immunoassay kits using carriers such as microplates, tubes, magnetic particles, microbeads, and plastic beads.

Development Information

Word Count: 12 Thousand words Pages: 7 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/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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