GARD®skin Medical Device.
ISO 10993-10:
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.
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Preparing for the regulatory transition towards NAMs
As ISO 10993-10 continues to evolve, medical device manufacturers that begin building NAM-based expertise today can strengthen their readiness for future regulatory expectations by:
- Building internal NAM-relevant databases
- Gaining hands-on experience interpreting NAM-based results
- Strengthening weight-of-evidence in regulatory submissions
- Reducing late-stage regulatory risks
- Aligning with 3Rs principles and sustainability goals
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.
The number of biomarkers used in GARDskin Medical Device.
