GARD®skin Medical Device.

In vitro skin sensitization testing for medical devices and solid materials

GARDskin Medical Device offers an in vitro alternative for skin sensitization testing as a part of the Biological Evaluation of Medical Devices according to ISO 10993.

As an adaptation of GARDskin, the assay can directly test extracts of medical devices and solid materials, classifying the test item as either a skin sensitizer or non-sensitizer.

To meet the demand for 3R, the test is human-relevant, highly accurate and efficient, with markedly shorter turnaround time comparing to the traditional animal study.

Use both saline and oil as extraction vehicles

GARDskin Medical Device can predict skin sensitizing hazard of medical devices and solid materials by testing extractables:

  • Human relevant with high accuracy.
  • The test system supports both polar and non-polar extraction vehicles as recommended in ISO 10993-12.
  • With demonstrated ability to handle complex mixtures.
200 genes

The number of biomarkers used in GARDskin Medical Device.