In vitro skin sensitization testing of Medical Devices using GARD®

Rose-Marie Jenvert, Angelica Johansson, Olivia Larne, Emelie Danefur, Emil Altonen, Anders Jerre, Robin Gradin, Gunilla Grundström. SenzaGen, Lund, Sweden. Introduction All medical devices need to be evaluated for the end point skin sensitization according to the Biological Evaluation of Medical Devices (ISO 10993-1:2018), today commonly involving in vivo assays. Here, we show that the in […]
Rose-Marie Jenvert, Angelica Johansson, Olivia Larne, Emelie Danefur, Emil Altonen, Anders Jerre, Robin Gradin, Gunilla Grundström.
SenzaGen, Lund, Sweden.

Introduction
All medical devices need to be evaluated for the end point skin sensitization according to the Biological Evaluation of Medical Devices (ISO 10993-1:2018), today commonly involving in vivo assays. Here, we show that the in vitro assay GARD®skin Medical Devices can classify leachables as either skin sensitizers or non-sensitizers in polar and non-polar extraction of Medical Devices.

Conclusion
GARD®skin Medical Device

  • is an in vitro alternative for assessment of skin sensitization of Medical Devices
  • is compatible with the extraction vehicles salin, olive oil and sesame oil.

Link to poster

Poster publication at Eurotox, Helsinki, Sep 9, 2019.