YY/T 1970-2025 Pending Industry standards-Medicine

YY/T 1970-2025 Lipoprotein-associated phospholipase A2 testing kit(Chemiluminescent immuoassay)

YY/T 1970-2025 Lipoprotein-associated phospholipase A2 testing kit(Chemiluminescent immuoassay)

Publish Date: 2025-06-18 Implement Date: 2026-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1970-2025

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2025-06-18

Implement Date: 2026-07-01

Pages: 12 pages

Scope

This document specifies the requirements, marking, labeling, and user instructions for lipoprotein-associated phosphatase A2 assay kits (chemiluminescence immunoassay), as well as their packaging, transportation, and storage. It also describes the corresponding testing methods.
This document applies to assay kits that quantitatively measure lipoprotein-associated phosphatase A2 in human serum and plasma using the chemiluminescence immunoassay principle (hereinafter referred to as "assay kits"), including chemiluminescence analysis kits with carriers such as microplates, tubes, magnetic particles, microbeads, and plastic beads.

Development Information

Word Count: 12 Thousand words Pages: 12 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 191-2025 Graphical symbols marking for handling and storage of packages 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 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 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 YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements

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