Cytotoxicity, Irritation, Sensitization, Genotoxicity, Systemic Toxicity, Subchronic Toxicity, Implantation, Hemocompatibility, Pyrogenicity

Tests for genotoxicity, carcinogenicity and reproductive toxicity (TS EN ISO 10993-3, OECD-471):

In this context, genotoxicity tests are tests in which mammalian or non-mammalian cells (bacteria, yeast or fungi) are used to determine whether the test samples cause gene mutations, changes in chromosome structure or other DNA or gene changes. In this context, this experiment is applied as the determination of gene mutations in bacteria (Salmonella typhimurium) in accordance with the OECD 471 standard referred to by the ISO 10993-3 standard.

Selection of interaction tests with blood (Hemolytic Impact Test) (TS EN ISO 10993-4 / A1, ASTM F756-08):

Blood interaction experiments are carried out to examine the interactions between blood or any component of blood and the material that affect blood, tissues or organs. The hemolytic effect test within the scope of these experiments is the measurement of the increase in free plasma hemoglobin level caused by the loss / damage of erythrocytes by contact of the hemolytic substance with blood. For this purpose, the hemoglobin levels released by the contact of test and control substances or their extracts with rabbit blood are compared spectrophotometrically.

Outside the body (in vitro) Cytotoxicity Tests (TS EN ISO 10993-5):

The cytotoxicity test includes qualitative and quantitative evaluation of the damage that may occur in cells that come into contact with test and control substances or extracts. In this experiment performed in cell culture medium, Vero (CCL 81) African monkey kidney cell is used as the cell line.

Tests for Post-Implantation Local Effects (TS EN ISO 10993-6):

The implantation experiment is the microscopic and macroscopic examination of the local effects of test and control materials on living tissues where they are implanted. The implantation sites are selected according to clinical use, and samples are usually implanted into the rat gluteal muscle.

Skin Irritation Test (TS EN ISO 10993-10):

Skin irritation test is to examine the localized non-specific inflammatory response created by test and control materials in a single application. For this purpose, three rabbits are used for each sample.

Intradermal Irritation Test TS EN ISO 10993-10):

Intradermal irritation test is the examination of localized non-specific inflammatory response created by test and control materials in a single application. For this purpose, three rabbits are used for each sample.

Sensitization Test (TS EN ISO 10993-10):

The sensitization (hypersensitivity) test is based on the formation of Type IV (delayed) specific hypersensitivity in the skin of the guinea pig.

Acute Systemic Toxicity Test (TS EN ISO 10993-11):

Systemic toxicity tests are carried out to evaluate the general systemic toxicity potential of the substances released from the locally applied medical device and / or its raw material, as a result of absorption, metabolism and distribution from the local area of the body to distant organ systems. In this context, the acute systemic toxicity test examines the adverse effects that occur within 72 hours.

Pyrogenicity Test (TS EN ISO 10993-11, European Pharmacopoeia 7th Edition)

Pyrogenicity test is the measurement of the temperature rise detected after the application of a properly prepared sterile extract of the material to be examined to rabbits by iv injection. This test is done to determine if there is a material-mediated pyrogenicity.