ICS11.040.20 CCSC31 团 体 标 准 T/CAMDI155—2025 液相色谱用于临床治疗药物监测 通用技术要求 GeneraltechnicalrequirementsforClinicalTherapeuticalDrugMonitoringbyHigh performanceliquidchromatography 2025-12-22发布 2025-12-22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/CAMDI155-2025 I目次 目次.....................................................................................................................................................I 前言.................................................................................................................................................III 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治疗药物监测TherapeuticalDrugMonitoring；TDM...................................................................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样品保存........................................................................................................................................3 4.5试剂和耗材..............................................................................................................................