Determination of chemical contaminations of medical devices

A holistic determination of the chemical cleanliness of medical devices is not possible with a single analytical method due to the variety of different chemical impurities. Suitable methods must be selected for specific problems or combined in a sensible manner. Methods are available that present results as sum parameters (e.g. TOC for water-soluble impurities) or chromatographic and spectroscopic methods that allow conclusions to be drawn about possible sources of contamination.

In the context of biocompatibility assessment, chemical characterization according to DIN EN ISO 10993-18 is an essential part of the testing strategy to assess the biological compatibility of the residues or materials used. The toxicological evaluation according to DIN EN ISO 10993-17 as a basis for the assessment of biological compatibility requires the identification of chemical substances and compounds. For this purpose, chromatographic or spectroscopic procedures are suitable test methods.