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.
Hemolysis (Blood Interaction Tests) ISO 10993-4
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
Bacterial Reverse Mutation Test (AMES)
The Ames test determines whether a chemical is mutagenic or not.
Irritation and Skin Sensitivity Test
It is made to determine whether a medical device, material or chemical substance is irritating.
Gene Mutation Test (HPRT Test)
It is used to detect gene mutations induced by chemicals.
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.
European Pharmacopoeie 11-2 Bacterial Endotoxin Test (2.6.14)
It is performed to detect toxic structures in the cell walls of gram-negative bacteria.
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.
Sterility Tests
It is performed to detect the absence of live microbial cells in a sterilized product.
