Conducting a toxicological risk assessment (TRA) for a medical device is an important first step to evaluate safety, and TRAs are often used to address several biocompatibility endpoints, including systemic toxicity (acute, subacute, subchronic, and chronic toxicity), genotoxicity, carcinogenicity, and reproductive and developmental toxicity. However, chemical characterization requirements outlined in ISO 10993-18:2020 (e.g., range of solvent polarities that may not be clinically relevant, elevated time and temperature, concentration of extracts to meet the analytical evaluation threshold) often lead to very large datasets and unfavorable TRAs. Therefore, more risk assessment tools are needed to streamline large risk assessments and help toxicologists better characterize potential risk.
In this webinar, some new terms introduced in the updated version of ISO 10993-17 will be discussed, including identified constituent, total quantity, toxicological screening limit (TSL), worst-case estimated exposure dose, and release kinetics. The impact of these additions will be discussed with a focus on the TSL and assumed release. The TSL can be applied to screen chemicals for short- and long-term risk. Assumed release refers to adjustments to the worst-case estimated exposure based on release days. Both the TSL and assumed release concepts have the potential to significantly impact TRA approaches.
The second half of the webinar will focus on a case study that applies the TSL and assumed release concepts. Considerations for application of these tools will be demonstrated through the case study, and will provide an example of how both can be applied and documented in a TRA.
The new approaches introduced in ISO 10993-17:2023 are impactful. The standard provides extensive guidance around risk assessment for medical devices, which should improve consistency. It also introduces new tools to streamline the TRA process without additional testing, which has the potential to save both time and money.
Learning Objectives:
- Understand why ISO 10993-17 is important
- Gain insight into key changes in the updated version of ISO 10993-17
- Discover how to apply the TSL to screen large numbers of chemicals
- Learn how exposure can be adjusted for release days to mitigate concerns in exhaustive extractables
