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 (OECD TG 442E), the assay can directly test extracts of medical devices and solid materials, classifying the test item as either a skin sensitizer or non-sensitizer.

Use both saline and oil as extraction vehicles

The test system supports both polar and non-polar extraction vehicles as recommended in ISO 10993-12.

Meet the demand for 3Rs

The test is human-relevant and highly accurate, with a markedly shorter turnaround time compared to the traditional animal study, and with demonstrated ability to handle complex mixtures.

A highly accurate and ethical alternative to animal testing

Our GLP-certified laboratories provide in vitro biocompatibility testing addressing the three endpoints that all medical devices are subjected to assess:

Interested in potency information?

GARD®skin Dose-Response can be used for risk assessment of chemicals found during chemical characterization, providing quantitative potency information on skin sensitization.

196 genes

The number of biomarkers used in GARDskin Medical Device.