The revision of part 18 of the ISO 10993 series is now available as final draft and can be purchased from several websites. The new title “chemical characterization of medical device materials within a risk management process” suggests some important changes compared to the previous version.
In this webinar the main changes are highlighted including the use of an Analytical Evaluation Threshold (AET) and the importance of accurate identification and quantification of compounds for a subsequent toxicological assessment. In addition, we’ll explain when an Extractables study should be performed, how to design this study and how it differs from a Leachables study.
By the end of this webinar you should know:
- When and how to set-up an Extractables and/or Leachables study as part of an overall risk management
- The difference between a screening and targeting analytical technique
- Why and how to calculate an Analytical Evaluation Threshold
- The importance of reliable compound identification and quantification
