biokompatiblen

Biokompatiblen is the term used to describe the biocompatibility of materials intended for medical or dental use. Biocompatibility refers to the ability of a material to perform with an appropriate host response in a specific biological context, without causing adverse effects such as cytotoxicity, sensitization, inflammation, or systemic toxicity. Biokompatibility is context-dependent; a material that is compatible with one tissue or duration of contact may be unsuitable in another situation.

Assessment typically follows a risk-based framework and is guided by international standards, notably the ISO 10993 family of standards for the biological evaluation of medical devices. Practical work includes in vitro tests for cytotoxicity, hemocompatibility and irritation, as well as in vivo studies for implantation effects and systemic toxicity. The duration and type of tissue contact (limited, prolonged, or permanent) influence the evaluation strategy.

Common materials used for biocompatible applications include titanium and its alloys, ceramics, silicone and other polymers, and surface-modified materials designed to reduce adverse reactions. Biocompatibility considerations cover not only the bulk material but also additives, degradation products, sterilization effects, and potential leaching of contaminants. Applications span implants, dental restorations, catheters, wound dressings, prosthetics, and tissue engineering scaffolds.

Regulatory frameworks require documentation of biocompatibility to support device approval or CE marking, with risk management and ongoing post-market surveillance. Ongoing research addresses context-specific responses, long-term effects, and the influence of patient variability, as well as the development of standardized testing that better predicts in vivo outcomes.