YY/T 1192-2011 (English Version) PDF

Scope: This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of human chorionic gonadotropin (HCG) quantitative determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative detection of human chorionic gonadotropin (HCG) reagents (kits) in human blood matrix or other body fluid components based on the principle of chemiluminescence immunoassay [hereinafter referred to as "HCG reagents (kits)"]. 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) Human chorionic gonadotropin calibrators and human chorionic gonadotropin quality control products intended to be sold separately; b) Biochips based on chemiluminescence immunoassay.

YY/T 1192-2011 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

2011 YY/T 1192-2011 Human chorionic gonadotropin(HCG) quantitative detection reagent(kit) (chemilumiuescent immunoassay)