YY/T 1233-2014 in English

本标准适用于以化学发光免疫分析法为原理定量测定人心肌肌钙蛋白-I(cTnI)的试剂（盒），包括以微孔板、管、磁颗粒等为载体的酶促及非酶促化学发光免疫分析测定试剂（盒）。
本标准规定了心肌肌钙蛋白-I定量测定试剂（盒）（化学发光免疫分析法）的术语和定义、分类、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存等内容。
本标准不适用于对试剂盒中的校准品和质控品的要求。

Scope

This standard specifies the terms and definitions, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of cardiac troponin-I quantitative determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of human cardiac troponin-I (cTnI) based on the principle of chemiluminescence immunoassay reagent (kit) [hereinafter referred to as "cTnI reagent (kit)"], including microwell plates, tubes, Enzymatic and non-enzymatic chemiluminescence immunoassay assay reagents (boxes) using magnetic particles as carriers. This standard does not apply to the requirements for calibrators and quality control materials in kits.