Fundamental Biological Evaluations
Cytotoxicity
In vitro evaluation to determine potential harmful effects of biomaterials on cells. Damage to cell membrane integrity and cellular metabolism is analyzed using L2929 Mouse Fibroblast cell lines.
Irritation
Determines whether the material creates an inflammatory response on skin, eye, or mucosal surfaces. Swelling, redness, and localized inflammation occurring as a result of direct contact are measured by grading.
ISO 10993-10Sensitization
Examines Type IV delayed hypersensitivity (allergy) reactions. With experiments conducted on guinea pigs, the potential of the material to cause an allergic response in the immune system is measured.
ISO 10993-10Toxicity and Genetic Evaluations
Genotoxicity
DNA damage, chromosome abnormalities, and mutagenic effects are examined in vitro and in vivo by bacterial mutation methods such as the Ames test.
Systemic Toxicity
Analysis of acute side effects that may occur in distant organs (liver, kidney, etc.) in case the material enters the systemic circulation.
ISO 10993-11Subchronic Toxicity
Histopathological effects of repeated exposure for three months or longer on organ functions and general health status are evaluated.
ISO 10993-11Implantation
Local reactions created in living tissues (fibrosis, inflammation, etc.) are monitored by macroscopic and microscopic methods.
ISO 10993-6Blood Interaction and Fever Reactions
Hemocompatibility
Adverse effects on blood components, erythrocyte damage (hemolysis), and platelet activation are tested.
Pyrogenicity
Measures by intravenous methods whether the material contains pyrogenic agents that can cause fever in the body.