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

Qualification of a Gas Chromatography/Mass Spectrometry (GC/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 GC-MS method qualification for use in general screening of extractables from medical devices.

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1. Verfasser: Alan Hendricker
Format: Dataset
Sprache:eng
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Zusammenfassung:This technical note summarizes the qualification of a GC-MS method qualification for use in general screening of extractables from medical devices.
DOI:10.17632/rddfdc2p29.1