Hemolysis (Blood Interaction Tests) ISO 10993-4

It is based on the spectrophotometric measurement of erythrocyte loss and the increase in the level of free plasma hemoglobin secreted as a result of damage, which occurs as a result of the interaction of the materials used in the devices that come into contact with blood, directly or the interaction of the extracted solution with rabbit blood. The presence of hemolytic material in contact with blood can cause damage to red blood cells and produce high levels of free plasma hemoglobin, which induces toxic effects that can stress organs. In our center, blood compatibility and hemolysis tests are performed according to ISO 10993-4 and ASTM F756-17 standards.

Other Tests

Test for Mammalian Chromosome Abnormalities

Chromosomal abnormalities (CA) refer to a numerical or structural change in the chromosome. CA test is used to detect various structural and numerical abnormalities by mutagens

Hemolysis Test

Blood interaction tests are performed to determine the possible effects of medical devices that interact directly or indirectly with blood.

Cytotoxicity Test

Cytotoxicity is carried out with the aim of determining the toxic effects that can be caused by the contact of medical devices interacting with the body.

Stability Test

It is carried out to determine the time effects on the physical properties of medicinal products and their packages.

Bioburden Test

Bioburden is defined as the number of living microorganisms present in a given amount of material before medical equipment or devices are subjected to the sterilization procedure.