What is a Biocompatibility Test?

Biocompatibility refers to the mutual adaptability between medical materials and the patient’s tissues and physiological systems. The clinical success of medical materials and their safe use are mainly due to their good biocompatibility. Generally, some medical materials will release toxic substances during use, resulting in incompatibility with patients. For the purpose of monitoring biocompatibility, medical materials and their extracts are generally simulated in the worst case to ensure safety under normal conditions of use.

Biocompatibility refers to the ability of living tissues to react to inactive materials, and generally refers to the compatibility between the material and the host. After the biomaterial is implanted in the human body, it will have an impact and effect on the specific biological tissue environment, and the biological tissue will also have an impact and effect on the biomaterial. The cyclic effect of the two continues until equilibrium is reached or the implant is removed.

Biocompatibility can be divided into two parts: biological reaction and material reaction. The biological reaction includes blood reaction, immune reaction and tissue reaction; material reaction is mainly manifested in the change of the physical and chemical properties of materials.

Biocompatibility is mainly determined by the nature and use of the material. The properties of materials and products themselves, including shape, size and surface roughness, residual toxic low-molecular substances during material polymerization or preparation, material processing pollution, material degradation products in the body, etc. are all related to their biocompatibility. The short-term contact between the material and the body will cause toxicity, irritation, teratogenicity and local inflammation to the cells and the whole body; long-term contact may have mutagenic, teratogenic and carcinogenic effects; contact with blood can cause abnormal blood coagulation and hemolysis. Therefore, when When considering the use of materials in the field of biomedicine, their biocompatibility is an important indicator that needs to be considered and evaluated.

There are many items for biocompatibility testing, and there are usually three items that are most commonly tested:

• Cytotoxicity test:

Biological evaluation of medical devices. Part 5: In vitro cytotoxicity test GB/T 16886.5-2003ISO 10993-5-1999

• Skin irritation test:

Biological evaluation of medical devices. Part 10: Irritation and delayed-type hypersensitivity test GB/T 16886.10-2005 ISO 10993-10: 2002

• Sensitization test:

Biological Evaluation of Medical Devices Part 10: Irritation and Delayed Hypersensitivity Test GB/T 16886. 10-2005 ISO 10993-10: 2002

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