In this webinar, the speakers will discuss the uses of in vitro assays as a part of the risk assessment and biological evaluation for the following endpoints: cytotoxicity, skin irritation and skin sensitization.
The presentation will introduce biological evaluation and biocompatibility testing of medical devices, with focus on in vitro assays for skin irritation and skin sensitization now implemented in the ISO 10993-23:2021 and ISO/FDIS 10993-10:2021. For assessment of skin sensitization, the GARD™-technology will be introduced and the speakers will discuss how it can be used as a part of a biological evaluation.
The webinar will conclude with customer cases where in vitro assays, including GARDskin Medical Device assay and GARDskin Dose-Response, have been successfully utilized for risk assessment as part of the biological evaluation and for risk-based decision-making in compliance with the principles of the 3Rs throughout the product life cycle.
A highly accurate and ethical alternative
An exciting evolution is ongoing in the medical device toxicology field, transitioning from a process that largely relied on the results of animal testing to one which is increasingly focused on the use of in vitro methods for the safety assessment of medical device materials. A big step towards replacing animal testing for medical devices was taken when in vitro skin irritation testing using Reconstructed human Epidermis (RhE) tissue was implemented in the ISO 10993-23 standard published earlier this year. Moreover, in vitro assays for skin sensitization have been included in the updated ISO 10993-10.
In vitro biocompatibility package
The in vitro biocompatibility package includes testing of the three endpoints that need to be evaluated for all medical device products: cytotoxicity, skin irritation and skin sensitization, offering a solution for customers looking for a highly accurate and ethical alternative for testing of materials and medical devices.
The endpoint cytotoxicity can be tested in vitro using qualitative and quantitative test methods as described in ISO 10993-5:2009 and have a history of use both for regulatory purposes and as a screening tool early in the product development phase.
The endpoint skin irritation using RhE-tissue according to ISO 10993-23:2021 provides human relevant results with higher accuracy and less false positive results compared to the rabbit model.
Skin sensitization with GARD™
The endpoint skin sensitization can be assessed in vitro using the GARDskin Medical Device assay, based on a state-of-the-art technology GARD; including human immunological cells, a specific genomic biomarker signature and a machine learning-assisted classification-model. The GARDskin Medical Device assay enables the medical device industry to perform in vitro skin sensitization testing of both saline and oil extracts from devices or materials as described in ISO 10993-12 and FDIS/ISO 10993-10:2021, thus mimicking the intended use of the device when in contact with skin.