In Vitro Irritation on Skin and other Epithelia.
ISO 10993-23: Skin Irritation on Reconstructed Human Epidermis
The skin irritation potential of medical devices, medical device components or extracts are assessed using 3D reconstructed human epidermis (RhE) models.
The test method allows classifying medical devices or materials as irritants or non-irritants based on cell viability outcomes after 24h exposure and 50% cell viability threshold.
Polar and non-polar extracts of the test item are prepared according to ISO 10993-12.
Special irritation tests: Irritation on other Epithelia
We help you assess the irritation potential of your medical devices and their components using advanced 3D human tissue models.
In accordance with ISO 10993-23, we offer irritation testing on a range of tissues beyond the skin, including:
- Corneal
- Vaginal
- Oral
- Esophageal
- Nasal
- Ocular
- Colorectal
- Intestinal
Our in vitro models are specifically qualified for Medical Devices, ensuring accurate and reliable irritation assessments.
An ethical and accurate alternative to animal testing
Our GLP-compliant laboratories provide in vitro biocompatibility testing addressing the three endpoints that all medical devices are subjected to assess:
