Biocompatibility is defined as the compatibility of materials, that are in physical, chemical or biological contact with the body, with the body’s systems, not damaging the surrounding tissues, compatibility with tissues, not exerting toxic effects and not causing inflammation. A biocompatible product is a product that is in harmony with the living thing and is not rejected by the immune system. Thus, a medical device is expected to elicit an optimal cellular or tissue response without producing undesirable, systemic effects.
with 10 Different In Vitro tests.
What is Biocompatibility?
Working Hours
| Monday-Friday | 08:30 – 18:00 |
| Saturday | 08:30 – 13:00 |
| Sunday | Closed |
Tests
Irritation and Skin Sensitivity Test
It is made to determine whether a medical device, material or chemical substance is irritating.
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.
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.
Bacterial Reverse Mutation Test (AMES)
The Ames test determines whether a chemical is mutagenic or not.
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
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.
Hemolysis Test
Blood interaction tests are performed to determine the possible effects of medical devices that interact directly or indirectly with blood.
