Biocompatibility testing is a performance evaluation method used to evaluate the biological, physical, and chemical reactions of living tissues to inactive materials. It simulates the reaction of materials using medical products in specific parts of the body and judges the degree of biocompatibility of these materials. Good biocompatibility is the main reason why medical materials can be widely used in clinical practice.
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Biocompatibility usually includes two categories: histocompatibility and hemocompatibility
1.Histocompatibility - including cell adsorption, non-inhibition of cell growth, cell activation, resistance to cell protoplasmic transformation, anti-class, non-antigenic, non-mutagenic, non-carcinogenic, non-teratogenic, etc.;
2.Hemocompatibility - refers to anti-platelet thrombosis, anticoagulant, anti-hemolytic, anti-leukopenia, anti-complement hyperactivity, anti-plasma protein adsorption and anti-cytokine adsorption.
At present, the biomedical materials used for implantable devices in vivo include various polymer materials such as silicone rubber, epoxy resin, polyethylene, and polyester, as well as various metal materials such as platinum, titanium, tantalum, and stainless steel. Long-term implantation devices also need to choose corrosion-resistant alloys, such as titanium alloys, platinum alloys, cobalt alloys, etc., as packaging materials, in addition to high biocompatibility, these materials also have the advantages of high stability, sealing, small deformation, and high mechanical strength.
Biocompatibility testing items:
In vitro cytotoxicity, sensitization, stimulation, intradermal reaction, oral mucosal stimulation, stimulation, rectal stimulation, eye stimulation, hemocompatibility, abnormal toxicity, acute systemic toxicity, subacute systemic toxicity, subchronic systemic toxicity, chronic systemic toxicity, pyrogen, chromosomal aberration, micronucleus test, gene mutation test, AMES test, thrombosis, coagulation, platelet adhesion, complement activation, muscle implantation, subcutaneous implantation, bone implantation, light reaction, material characterization analysis, etc.
Biocompatibility testing of medical devices is an important part of ensuring the safety and effectiveness of medical devices. It helps to reduce the risk of patients experiencing adverse reactions when using medical devices and ensures the reliability of medical devices in medical practice.