Qualification of an Inductively Coupled Plasma Mass Spectrometry (ICP-MS) Semi-quantitative 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 ICP-MS method for use in elemental extractables testing from medical devices and medical device componentry.本技术说明概述了电感耦合等离子体质谱法（Inductively Coupled Plasma Mass Spectrometry，ICP-MS）在医疗器械及其组件的元素可提取物检测中的方法验证工作。