AMES Test (Bacterial Reverse Mutation Analysis) OECD 471

The Ames test determines whether a chemical is mutagenic or not. The basis of this test is based on the principle that Salmonella typhymurium/Escherichia coli WP2 uvrA strains, which do not have the ability to synthesize histidine, which are created by artificial mutation, after being treated with the test component, gain the ability to synthesize histidine / tryptophan by undergoing a second mutation and can reproduce in histidine / tryptophan independent environment.

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.