ICS11.040.20 CCSC31 团 体 标 准 T/CAMDI165—2025 液相色谱用于临床维生素A、维生素E、25-羟基维生素D2/D3检测 通用技术要求 Generaltechnicalrequirementsformeasurementof VitaminA、VitaminE、25-hydroxyvitaminD2/D3byHighperformanceliquid chromatography 2025-12-31发布 2025-12-31实施 中国医疗器械行业协会发布 全国团体标准信息平台 T/CAMDI165-2025 目次 前言.................................................................................................................................................IV 1范围......................................................................................................................................................1 2规范性引用文件...................................................................................................................................1 3术语和定义...........................................................................................................................................1 3.1液相色谱Highperformanceliquidchromatography,HPLC............................................................1 3.2选择性Selectivity............................................................................................................................1 3.3残留Residue...................................................................................................................................1 3.4定量下限Lowerlimitofquantification.............................................................................................1 3.5线性Linearity...................................................................................................................................1 3.6正确度Accuracy..............................................................................................................................2 3.7精密度Precision..............................................................................................................................2 3.8稀释可靠性Dilutionreliability..........................................................................................................2 3.9可报告范围Reportablerange.........................................................................................................2 3.10信噪比Signal-to-NoiseRatio；SNR.............................................................................................2 3.11基质Matrix.....................................................................................................................................2 3.12稳定性Stability..............................................................................................................................2 3.13脂溶性维生素fat-solublevitamins；FSV......................................................................................2 4实验基本要求.......................................................................................................................................2 4.1实验室基本要求................................................................................................................................2 4.2人员要求...........................................................................................................................................3 4.3液相色谱设备的基本要求.................................................................................................................3 4.4样品采集、运输和存储要求..............................................................................................................3 4.4.1样品采集........................................................................................................................................3 4.4.2样品运输........................................................................................................................................3 4.4.3样品的保存....................................................................................................................................3 4.5试剂和耗材........................................................................................................................................3 5方法学建立...........................................................................................