In Vitro Biocompatibility Testing of Medical Devices.

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:

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.