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.
The biological assessment of gas pathways in medical devices is a special case. The mere application of DIN EN ISO 10993-1 can lead to tests of dubious benefit and the failure to recognise potential hazards. For this reason, the DIN EN ISO 18562 series of standards offers an alternative for the biological assessment of gas pathways of a medical device and its parts or accessories intended for ventilation or the supply of substances via the respiratory tract of a patient.
- 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 according to DIN EN ISO 10993-5 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 chemico test for sensitisation by a molecular event in the form of a covalent protein binding according to DIN EN ISO 10993-10, Annex C
The DPRA is a method in which the reactivity of a product extract is quantitatively determined by the depletion of synthetic cysteine- or lysine-containing peptides. The percentage depletion values are calculated and a prediction model is used to classify the product as sensitising or non-sensitising to the skin.
- In vitro test for sensitisation by activation of epidermal keratinocytes according to DIN EN ISO 10993-10, Annex C
The skin sensitisation is evaluated by measuring the basal release of IL-18 after application of a product extract to the air-liquid interface of the reconstructed human epidermis (RhE) (test can be combined with the test for skin irritation according to DIN EN ISO 10993-23)
- In vitro test for sensitisation by activation of epidermal dendritic cells according to DIN EN ISO 10993-10, Annex C
In the U-SENS test, the changes in the expression of the cell surface marker CD86 on U937 cells are quantitatively determined using flow cytometry. The reaction of the human immune cells to the sample extract allows the assessment of an allergenic hazard potential of the examined sample.
- Biocompatibility evaluation of breathing gas pathways in healthcare applications
- DIN EN ISO 18562-1 Evaluation and testing within a risk management process
- DIN EN ISO 18562-2 Tests for emissions of particulate matter
- DIN EN ISO 18562-3 Tests for emissions of volatile organic compounds (VOCs)
- DIN EN ISO 18562-4 Tests for leachables in condensates
- 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.