biokompatibilia

Biokompatibilia is a term used to describe the compatibility of a material or device with living tissue and biological systems. It encompasses the ability to perform a function in a biological environment without causing adverse effects such as toxicity, inflammation, irritation, or immune rejection. In practice, biokompatibilia is a central consideration in the design and assessment of medical implants, devices, and biomaterials that come into contact with the human body.

Biokompatibilia is context-dependent; properties acceptable in one application may not be in another. Criteria include non-toxicity, stability under sterilization, mechanical compatibility with surrounding tissue, resistance to corrosion, and non-immunogenicity. It also involves predictable interactions over time, including tissue integration for certain implants or inert behavior for others.

Testing and regulation: Evaluation follows standards such as the ISO 10993 family. In vitro tests assess cytotoxicity, sensitization, and irritation; in vivo tests examine local and systemic responses. Regulatory agencies (for example, the FDA in the United States or CE marking in Europe) require device-specific biocompatibility data and risk assessment according to the device class.

Common materials and approaches: Metals (titanium alloys, stainless steels, cobalt–chromium) and ceramics (zirconia, alumina) are used for structural implants; polymers (silicone, PTFE, UHMWPE, PEEK) are used for seals, elastomers, and carriers; surface modifications (hydroxyapatite coatings, oxide layers, parylene) enhance tissue interaction and corrosion resistance.

Applications and challenges: Biokompatibilia underpins orthopedic, dental, cardiovascular, and neural devices, as well as wound dressings and drug-delivery systems. Ongoing challenges include wear debris, infection, patient variability, and long-term stability of leachables. Current research emphasizes bioactive and biodegradable materials, advanced surface engineering, and additive manufacturing for customized solutions.