Test criteria

With test procedures based on the DIN EN ISO 10993 series of standards, whose tests are mandatory for medical products, textiles in the healthcare sector or products for sensitive target groups (e.g. allergy sufferers) can also be tested for their particularly good compatibility. 
The test to exclude cell damage serves as the basis for the "medically tested" quality label. Additional tests can be ordered. All tests are based on test reports with detailed results.

 

In a cell culture test, cell-damaging substances that can be released from the sample material when worn are detected with the help of skin cells in relation to their effect. The cytotoxicity test according to DIN EN ISO 10993-5 is the initial step of numerous biocompatibility tests in the DIN EN ISO 10993 series of standards.

For this test, an extract of the sample material is prepared which cultivated with L 929 skin cells in different concentrations over several days. The vitality of the cells or the potential cell-toxic effect of the test material is quantitatively determined in comparison to control cultures. 

A prerequisite for the award of the label is that the substances released from the test item have no cell-toxic effect. The quality label is based on a test report with detailed results.

The cell culture test uses immune cells to detect the allergy potential of substances that may be released from the sample material when worn. The sensitisation test is a general screening test for the detection of an allergenic effect. The technical prerequisite for the sensitisation test is passing the cytotoxicity test. For the test, an extract of the sample material is prepared and incubated with immune cells for 48 hours. Sensitising substances stimulate the cells to form surface markers to which specific fluorescence-labelled antibodies are bound. In the flow cytometer, the percentage of positive cells is determined by the fluorescence intensity. 

A prerequisite for the award of the label is that no sensitisation potential is detected by the sample.
The quality label is based on a test report with detailed results.

 

The irritating effect of materials is quantitatively determined on the basis of membrane changes on the mucous membrane of a chicken egg. The test thus allows the assessment of a hazard potential for skin irritation. 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).

For the test, an extract of the sample material is prepared and placed on the chorionallantoic membrane (CAM) of incubated chicken eggs for a few minutes. Certain textiles or creams/ointments/solutions can be applied directly to the CAM. The strength of three different types of reaction of the CAM (coagulation, haemorrhage and lysis of blood vessels) is determined according to the endpoint method. 

A prerequisite for the award of the label is that no highly irritating substances are released from the test material (test result: not to slightly irritating, score ≤ 10). The quality label is based on a test report with detailed results.

Proof by presentation of a valid STANDARD 100 by OEKO-TEX® certificate or commissioning of the STANDARD 100 by OEKO-TEX® certificate.

The Hohenstein Laboratories are accredited by DAkkS for all the above tests.

MORE ABOUT BIOCOMPATIBILITY TESTING