A chemical characterization study of a medical device per ISO 10993-18 provides invaluable data for the toxicological risk assessment (TRA). It is crucial that high confidence and thorough extractable data be provided by a laboratory to the toxicologist for assessment. Instrumental and interpretative approaches to the extractable data have evolved since the inception of Part 18 and since the 2020 ISO revision. High resolution mass spectrometry and data deconvolution techniques are the state-of-the-art for chemical characterization of medical devices.