Presentation | Extractables & Leachables Studies - An Important Part of Biocompatibility Assessments


Patient safety requires precise knowledge about extractables and leachables released by medical devices. The high complexity of many medical devices increases the risk of leaching and so proper chemical characterization is a mandatory step in biocompatibility studies. During the Medical Device Regulations & Compliance Online Summit (May 2022), our expert Tino Otte, Head of Consulting and Sales, will present on "Extractables & Leachables Studies as an important part of Biocompatibility Assessments"
During his presentation, Tino will cover the framework for extractables and leachables design including ISO 10993-18 and will use case studies and examples of analytical screening strategies to illustrate the following:
  • Depending on device class, application scenario and contact time E&L study design needs to be aligned
  • 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 which could cause unexpected problems
  • Typical problems and limitations during analysis will be discussed

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