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!