This standard specifies the requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of brain natriuretic peptide and amino-terminal brain natriuretic peptide precursor detection reagents (boxes) (quantitative labeling immunoassay method). This standard applies to reagents (kits) for quantitative detection of brain natriuretic peptide [hereinafter referred to as "BNP reagents (kit)"] and reagents (kits) for quantitative detection of amino-terminal brain natriuretic peptide precursors [hereinafter referred to as "BNP reagents (kit)"] NT-proBNP detection reagent (box)"]. This standard does not apply to: a) Various types of glue gold-labeled test papers; b) Various types of radioimmunoassay or immunoradiation kits labeled with Class I radioactive isotopes.
YY/T 1451-2016 Referenced Document
GB/T 191 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
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 1451-2016 history
2016YY/T 1451-2016 B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide test reagent (quantitative labelling immunoassay)