YY/T 1175-2010 (English Version) PDF

Scope: This standard specifies the terms and definitions, classification, requirements, test methods, identification, labels, instructions for use, and packaging of tumor marker quantitative determination reagents (kits) (chemiluminescence immunoassay) [hereinafter referred to as "reagents (kits)"] , transportation and storage. This standard applies to reagents (kits) for the quantitative determination of human tumor markers based on the principle of chemiluminescence immunoassay. Including enzymatic and non-enzymatic chemiluminescence immunoassay assay reagents (boxes) using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers. This standard does not apply to: a) Tumor marker calibrators and tumor marker substance control substances intended to be sold separately; b) Biochips based on chemiluminescence immunoassay.

YY/T 1175-2010 Referenced Document

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

2010 YY/T 1175-2010 Quantitative detection reagent (kit) for tumor markers.Chemiluminescent immunoassay