European Pharmacopoeie 11-2 Bakteriyel Endotoksin (2.6.14)

It is carried out to evaluate the potential of medical devices and materials to cause systemic acute toxic effects. Endotoxins are complex lipopolysaccharides located in the outer cell wall of gram-negative bacteria and are responsible for the organization and stability of the cell wall. With the bacterial endotoxin LAL (Limulus Amebocyte Lysate) test, it is aimed to detect the toxic structures in the cell walls of gram negative bacteria. The LAL test is performed in accordance with the EP-11 standard.

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.