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 supports testing of extracts from medical devices and solid materials, classifying test items as either a skin sensitizers or non-sensitizers.
- Supports both polar and non-polar extraction vehicles (ISO 10993-12).
- Human-relevant with high predictive accuracy.
- Fully aligned with the 3Rs.
Powered by genomics and machine learning, the assay is human-relevant and highly accurate, enabling shorter turnaround times compared to traditional animal studies.
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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.
