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.
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.
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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:
- Cytotoxicity: ISO 10993-5
- Irritation on skin and other epithelia: ISO 10993-23 using 3D reconstructed human tissues
- Skin sensitization: ISO 10993-10 using GARD®skin Medical Device
with over 90% accuracy and demonstrated applicability for use with the extraction vehicles saline and oil
GARD®skin Dose-Response can be used for risk assessment of chemicals found during chemical characterization, providing quantitative potency information on skin sensitization.
The number of biomarkers used in GARDskin Medical Device.