Presentation Recording | Extractables & Leachables Studies - An Important Part of Biocompatibility Assessments
Patient safety requires precise knowledge about extractables and leachables released by medical devices. The complexity of many medical devices increases the risk of leaching and suitable chemical characterization is a mandatory step in biocompatibility studies. During the Medical Device Regulations & Compliance Online Summit, our expert Tino Otte, Head of Consulting and Sales, presented on "Extractables & Leachables Studies as an important part of Biocompatibility Assessments."
During his presentation, Tino covered the framework for extractables and leachables design including ISO 10993-18 and used case studies of analytical screening strategies to illustrate the following points:
- E&L study design needs to be aligned to the device class, application scenario and contact time.
- Several analytical screening techniques should be utilized to cover all compound classes from volatile to non-volatile.
- Harsh extraction conditions might be required depending on the application scenario
- Typical problems and limitations during analysis.
Watch the recording now or access it at your leisure!