DZ/T 0101.12-1994
Active
YY/T 1962-2025
Active
Industry standards-Medicine
YY/T 1962-2025 Aldosterone testing kit (Chemiluminescent immunoassay)
YY/T 1962-2025 Aldosterone testing kit (Chemiluminescent immunoassay)
Basic Information
Standard Code:
YY/T 1962-2025
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2025-06-18
Implement Date:
2025-07-01
Pages:
12 pages
Scope
This document specifies the technical requirements, marking, labeling, and user instructions for the aldosterone assay kit (chemiluminescence immunoassay), as well as its packaging, transportation, and storage, and describes the corresponding test methods.
This document is applicable to kits used for quantitatively measuring aldosterone in human serum or plasma based on the principle of chemiluminescence immunoassay.
Development Information
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 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
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