During the biological evaluation of medical devices more and more emphasis is placed on the chemical and toxicological characterization based on recent updates of the ISO standards 10993-1 and 10993-18. The toxicological evaluation of ingredients and extractables and leachables and a respective risk assessment is performed according to ISO 10993-17.
The course will provide a basic understanding of the toxicological characterization of ingredients/extractable substances. It will give insights into toxicological endpoints such as irritation, sensitization, systemic toxicity, genotoxicity and carcinogenicity, extended to the more medical device specific ones like pyrogenicity, implantation effects or hemocompatibility. An overview on the regulatory requirements as well as the relevant standards will be provided. Chances and challenges of the approach of chemical and toxicological characterizations will be discussed.
Examples will illustrate the impact of toxicological evaluation on biological evaluation and moreover on the selection of the right materials for a medical device.
Important questions will be highlighted, such as:
- What information is required for a toxicological risk assessment?
- How does a toxicological risk assessment look like?
- How is the chemical characterization performed?
- Which toxicological properties are critical for biological safety?
- What are CMR substances?
- How do I handle unknown substances?