This standard stipulates the principles that should be followed when naming clinical chemistry in vitro diagnostic kits, and formulates specific naming examples for some items. This standard includes scope, normative reference documents, terms and definitions, requirements, etc. This standard applies to clinical chemistry in vitro diagnostic reagent (box) products that use spectrophotometry to conduct quantitative testing in medical laboratories using fully automatic biochemical analyzers, semi-automatic biochemical analyzers or spectrophotometers. This standard does not apply to calibrators and quality control products.
YY/T 1227-2014 history
2014YY/T 1227-2014 In vitro diagnostic reagent (kit) nomenclature for clinical chemistry