The basis for the biological assessment of medical devices is the DIN EN ISO 10993 series of standards. DIN EN ISO 10993-1 specifies which endpoints you must consider in the biological risk assessment of your product.
- Chemical characterisation according to DIN EN ISO 10993-18
In the chemical characterisation of materials for medical devices, components are recorded that can be released from the product. The chemical substances are determined by means of GC/MS. The test provides data for the biological assessment and the evaluation of the toxicological hazard potential within the framework of risk management.
- Cytotoxicity according to DIN EN ISO 10993-5
The cell culture test uses skin cells to detect cell-damaging substances (cytotoxins) that can be released from the sample material. The test thus allows the assessment of a 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 in vitro. The journal of the textile institute, Vol. 109, No. 7, 891-902.
- Testing for skin irritation according to DIN EN ISO 10993-23
The in vitro test for skin irritation utilises human three-dimensional skin models, which are composed of different cell layers analogous to the human epidermis. The test procedure is used to predict the irritation potential of extracts from medical products and their components via the viability of the RhE models.
- Test for irritation / mucosal damage
The HET-CAM according to DB-ALM Method Summary n° 96 is a recognised alternative to the animal test on the rabbit eye (Draize test), which is required according to DIN EN 10993-10. In the HET-CAM, coagulation, haemorrhage and lysis of blood vessels are determined on the chorionallantoic membrane of chicken eggs and three degrees of irritation are recorded as a result (no to mild / moderate / severe irritation).
- In vitro alternative method for sensitisation
In the cell culture test, the allergy potential (sensitisation potential) of substances that can be released from the sample material is recorded with the help of immune cells (so-called "guard cells"). The sensitisation test thus allows the assessment of an allergenic hazard potential of the examined sample.
- Further tests on request
Please also contact us on the subject of biocompatible coatings for medical devices. With our innovative test set-ups, we collect valuable preclinical data on this topic.