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Characteristics:

Biological Functionality:

Biomaterials are designed to fulfill specific biological functions. For instance, in drug delivery systems, their ability to release drugs at a controlled rate constitutes their biological functionality.

Biocompatibility:

This is a crucial characteristic of biomaterials, encompassing the interaction between the material and living tissues. It primarily includes tissue compatibility and blood compatibility. Tissue compatibility necessitates the absence of toxicity, carcinogenicity, pyrogenicity, and immune rejection. Blood compatibility ensures no thrombosis, hemolysis, or other adverse reactions upon contact with blood.

Chemical Stability:

Biomaterials must remain stable in vivo or in vitro, without undergoing detrimental chemical changes. This includes resistance to biological aging or controlled biodegradability, ensuring functional integrity over the required period.

Processability:

Biomaterials should be easily processed into the desired shapes and sizes to meet various application needs. They must also withstand various sterilization methods, such as UV sterilization, autoclaving, ethylene oxide gas sterilization, and alcohol disinfection.

Potential Hazards:

Biological Reactions:

Implantation of biomaterials may elicit a series of biological reactions, including exudate reactions, infections, calcification, thromboembolism, and tumorigenesis. Exudate reactions can result from the infiltration of low-molecular-weight substances during synthesis and processing. Infections are common complications in implant-based biomedical treatments. Calcification can impair the function of implanted biomedical devices. Thromboembolism is a concern for blood-contacting biomedical materials, requiring blood compatibility to prevent thrombosis. The carcinogenic potential of biomedical materials has been a subject of concern, necessitating chronic toxicity, genotoxicity, and carcinogenicity tests for long-term in vivo applications.

Mechanical Failures:

Biomaterials may experience mechanical failures such as fracture and wear during use, leading to implant failure or further harm to the body.

Material Residues:

Biomaterials may contain residues such as initiators, catalysts, residual monomers, and plasticizers. These residues can leach out after implantation, posing hazards to the human body.

In summary, the characteristics and potential hazards of biomaterials are crucial considerations in ensuring their safety and effectiveness. Comprehensive biological evaluations, physical and chemical performance assessments, and clinical studies are necessary to validate the suitability of biomaterials for specific applications. During design and manufacturing, attention must be paid to biocompatibility, chemical stability, and processability. When selecting and using biomaterials, a holistic approach considering the specific application needs, patient conditions, and material characteristics and hazards is essential. Continuous monitoring of the long-term performance of biomaterials in vivo and addressing potential biological reactions and mechanical failures is also critical.