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液相色谱串联质谱技术（LC-MS/MS）因结合了色谱的高分离性能和质谱高敏感、高特异性等优势被临床实验室广泛应用，但多应用于实验室自建项目，需要进行严格的方法评估，相关指导原则也应运而生，主要包括美国临床和实验室标准协会的C62-A文件、欧洲药品管理局和美国食品药品监督管理局的生物分析方法验证指导原则、人用药品注册技术要求国际协调会的M10《生物样品分析方法验证》指导原则征求意见稿以及日本卫生劳动福利部的生物分析方法验证指导原则，然而不同机构颁布的指导原则各有特点。本文结合我国现行的临床质谱应用建议，分析总结参考原则特点，为LC-MS/MS分析临床生物样品的标准化应用提供更多的参考。“,”Liquid chromatography tandem mass spectrometry (LC-MS/MS) is widely used in clinical laboratories due to its high separation performance, sensitivity and specificity. However, it is mostly used for laboratory developed tests, which requires strict method evaluation. Relevant guidelines were issued by different agencies have their own characteristics. including C62-A jssued by CLSI,guidelines for bioanalytical method validation (BMV) issued by European Medicines Agency (EMA) and Food and Drug Administration (FDA), the draft version of the guidelines for bioanalytical method validation (M10) issued by International Council on Harmonisation (ICH) and Ministry of health, labor and welfare (MHLW) of Japan. In this paper, we analyzed the similarities and differences of the above-mentioned guidelines in combination with the current clinical mass spectrometry application suggestions in China to provide more reference for the standardized application of LC-MS/MS.