According to ISO 10993
The in vitro assays for skin irritation and skin sensitization assessment of medical devices are now included in ISO 10993-23 and ISO 10993-10, respectively. Together with the in vitro methods for cytotoxicity assessment included in ISO 10993-5, they offer an ethical alternative to animal testing, with human relevance and high accuracy:
As part of the biological evaluation of finished medical devices
To address the three endpoints that need to be evaluated for all medical devices following the 3Rs principle.
As part of screening during the product life cycle
For the selection of safe materials and to investigate toxicological hazards for production and sterilization contaminants during product development.
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.