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.

本技术简报概括了用于医疗设备和医疗设备组件中元素可提取物测试的ICP-MS方法的验证过程。