Chemical Characterisation: a prerequisite for the biological evaluation
Following the approval of the Final Draft of ISO 10993-18 (ISO/FDIS 10993-18:2019, Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process) in June 2019, the final publication is expected early 2020. The focus of chemical characterization will not only be to evaluate the raw materials but also to take into account the presence of any impurities or residues associated with the manufacturing and sterilization process that may impact medical devices biocompatibility. Chemical characterization becomes a key factor in the assessment of the biological evaluation since obtained data are fundamental to correctly set the biological risk assessment of medical devices and also to plan how to evaluate biological effects relevant to the device.
This workshop will provide an up-to-date overview on normative changes of the new ISO 10993-18 in relation with the biological evaluation of devices and planning for future testing.