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?
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Tests
In this context, biocompatibility tests are important for the compatibility assessment of medical devices and materials. Products such as biomedical devices, drugs and implants produced or offered as a service in the biomedical sector must be documented with biocompatibility analysis.
In the process of certification or licensing of medical devices, materials and biocidal products with CE certificate, biocompatibility tests must be performed according to the international standard test protocol “ISO 10993 – Biological Evaluation of Medical Devices” and all materials used in the relevant device must be biologically compatible. The biocompatibility of the medical devices developed in this context against tissues on humans becomes clear as a result of the biocompatibility tests.
Bacterial Reverse Mutation Test (AMES)
The Ames test determines whether a chemical is mutagenic or not.
Hemolysis Test
Blood interaction tests are performed to determine the possible effects of medical devices that interact directly or indirectly with blood.
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.
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.
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.
Irritation and Skin Sensitivity Test
It is made to determine whether a medical device, material or chemical substance is irritating.
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
Sterility Tests
It is performed to detect the absence of live microbial cells in a sterilized product.
Stability Test
It is carried out to determine the time effects on the physical properties of medicinal products and their packages.
