Use of extractables and leachables (E&L) chemistry testing has become commonplace (and often essential) in medical device biocompatibility evaluations. The details of how E&L is conducted have received a lot of attention in the industry; however it must be remembered that this testing is conducted to serve a toxicological risk assessment (TRA) and it is the demands of proper toxicology that has put constraints on E&L in the first place. The ISO standard for TRAs, ISO 10993-17 is undergoing a long overdue update. This presentation will discuss updates present in the current draft of the new standard and how those will impact future TRAs, chemistry for toxicology, and biocompatibility at large.
- Fundamental principles of TRA for medical devices will be reviewed
- Updates to 10993-17 focus include rational exposure estimates
- The Threshold of Toxicological Concern (TTC) vs the Analytical Evaluation Threshold (AET)