Successful Implementation of Toxicological Characterization
The Toxicological Characterization of material components or leachable substances is an important tool for identifying potential health risks. It can serve as a basis for arguing against the use of certain biological tests on animals or for justifying why animal testing cannot be avoided.
The current requirements of ISO 10993-17 have expanded and clarified the toxicological risk assessment. In addition, individual requirements were further specified by Amendment 1 from 2025.
A toxicological risk assessment is no longer required only for leachable substances under clinical conditions of use, butalso for extractable components of medical devices. The approach to toxicological risk assessment is explained in detail.
We also deal in detail with the calculation of limit values and the estimation of maximum exposure.
In this interactive seminar, you will learn which toxicological endpoints are relevant for medical devices and how particularly hazardous substances can be identified. You will learn which components are part of a toxicological characterization, how to derive limit values, and which biological endpoints can be covered by the toxicological characterization.
Using specific examples, hazard identification is explored in greater depth through group work.
- Content
- Introduction to toxicology and relevant toxicological endpoints
- Identification of substances of very high concern
- Procedure for toxicological characterization
- Determination of hazard potential
- Investigation of the dose-response relationship
- Derivation of limit values
- Exposure assessment
- Comparison of exposure levels
- Examples of substances for hazard identification
- Your Benefits
- You will gain an overview of relevant toxicological endpoints and their significance for medical devices.
- You will learn about the various requirements for toxicological characterization.
- You will learn how a toxicological assessment is conducted.
- You will be able to review and approve toxicological characterizations.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Medical device manufacturers
- Regulatory affairs managers
- Research and development
- Toxicology
- Chemistry
- Quality assurance
