The basis for the biological assessment of medical devices is the ISO 10993 series of standards. (DIN EN) ISO 10993-1 specifies which endpoints you must consider in the biological risk assessment of medical devices.
- Chemical characterization - (DIN EN) ISO 10993-18
The chemical characterization of materials for medical devices identifies components that can be released from the product. The chemical substances are determined with the GC/MS test, which provides data for the biological assessment and & toxicological hazard potential for risk management.
- Cytotoxicity - (DIN EN) ISO 10993-5
The cell culture test uses skin cells to detect cell-damaging substances (cytotoxins) that can be released from the material. The test assesses hazard potential for cell damage. This is recorded as a sum parameter.
- Cytotoxicity for elastane-containing products (e.g. compression stockings) in conjunction with Wiegand, C. et al. (2017) *
Optimized protocol for the biocompatibility testing of compression stockings and similar products with close skin contact. *The journal of the textile institute, Vol. 109, No. 7, 891-902.
- Skin irritation - (DIN EN) ISO 10993-23
The in vitro test for skin irritation utilizes three-dimensional human skin models (composed of different cell layers analogous to the human epidermis). The test procedure predicts the irritation potential of extracts from medical devices (and their components) using the viability of the RhE models.
- Irritation/mucosal damage (HET CAM test)
The HET-CAM according to DB-ALM Method Summary n° 96 is a recognized alternative to animal testing on rabbit eyes (Draize test), which is required according to (DIN) EN 10993-10. In the HET-CAM, coagulation, hemorrhage and lysis of blood vessels are determined on the chorionallantoic membrane of chicken eggs and three degrees of irritation are recorded (no to mild / moderate / severe irritation).
- In vitro alternative method for sensitization
In the cell culture test, the allergy potential (sensitization potential) of substances that can be released from the sample material is recorded using immune cells (or "guard cells"). The sensitization test assesses the allergenic hazard potential of the sample.
- Biocompatibility of coatings
Our innovative test methods collect valuable preclinical data.
- Further tests on request