Qualification of a Liquid Chromatography/Mass Spectrometry (LC/MS) Semi-quantitative Screening Method used for Analysis of Extractables and Leachables from Medical Devices, Medical Device Componentry and Other Associated Materials

This technical note summarizes the qualification of a LC-MS method qualification for use in general screening of extractables from medical devices.本技术说明总结了液相色谱-质谱联用（Liquid Chromatography-Mass Spectrometry, LC-MS）方法的确认工作，该方法可用于医疗器械可提取物的常规筛查。