Three major standards, ISO 10993-1, -17 and -18 are going to be revised. For ISO 10993-1 “Evaluation and testing within a risk management process” a strong focus will be the chemi-cal characterisation of medical devices including medical device composition and extractables and leachables data. Also, additional biological and toxicological endpoints will have to be evaluated in line with the FDA guidance document. A major revision of ISO 10993-17 on allowable limits for leachable substances is in preparation including new con-cepts in risk assessment approaches. A major revision is also planned for ISO 10993-18 by incorporating new procedures and experimental requirements based on technical and scien-tific experience developed during the last 10 years.
An up-to-date overview on regulatory and normative changes will be provided to participants. In addition, you will also gain insight into normative trends by having the chance to discuss the standards in their editing state. This will be supported by
- Participants will be informed in detail about the approach on how to conduct a biological evaluation most efficiently, on the changes in the three standards and their consequences.
- Information will be given on the best and most efficient way to conduct a chemical characterisation, including information on the selection of chemical analytical methods for extractable and leachable studies.
- Toxicological hazard and risk assessment will play a major role in the future risk management process for medical devices. Participants will be informed about the approach, the content and the structure of expert statements for fulfilling the requirements of the global authorities.
- This will be supported by several practical examples and case studies where participants will gain an overview of the relevant guidelines and standards and their planned changes, as well as practical knowledge for the professional planning of biological studies and the biological and clinical evaluation of medical devices.