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.
ISO 10993-23: Irritation on other Epithelia
The irritation potential of medical devices and their components or extracts can be assessed on 3D reconstructed human epithelial models such as corneal, vaginal, oral, oesophageal, nasal, eye, colon-rectal and intestine as justified by ISO 10993-23 which allows assessing irritation responses on tissues other than skin using other in vitro models if qualified for use with medical devices.
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