YY/T 1218-2013 (English Version) PDF

Scope: This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of thyrotropin quantitative labeling immunoassay kits. This standard applies to kits for the quantitative determination of thyrotropin (TSH) based on the double-antibody sandwich method (hereinafter referred to as: TSH kit). It includes using enzyme labeling, (electro) chemiluminescent labeling, (time-resolved) fluorescent labeling and other labeling methods as capture antibodies, using microwell plates, tubes, magnetic particles, microbeads and plastic beads as carriers to coat the antibodies, and quantitatively determine TSH immunoassay kit. This standard does not apply to: a) colloidal gold-labeled TSH test strips; b) various types of radioimmunoassay or immunoradiation kits labeled with radioactive isotopes such as 125I.

YY/T 1218-2013 Referenced Document

YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update

2013 YY/T 1218-2013 Thyroid-stimulating hormone quantitative labelling immunoassay kit