biocompatibele

Biocompatibele is the feminine form of the Dutch adjective biocompatibel, used to describe materials or devices that can function in contact with living tissue without causing unacceptable harm. In practice, biocompatibility means that a material elicits an acceptable tissue response for a given application, exposure route and duration, and does not produce systemic toxicity, inflammation, or sensitization beyond acceptable limits.

The assessment of biocompatibility is performed according to international standards such as ISO 10993 and ASTM F748, within a risk-management framework (ISO 14971). The evaluation includes in vitro tests for cytotoxicity, chemical characterization, and extraction testing; in vivo tests for irritation or sensitization; and longer-term studies such as implantation tests to assess tissue response, degradation products, and systemic effects. The selection of tests depends on the device type, the estimated patient contact, and the duration of exposure.

Materials commonly regarded as biocompatible include medical-grade titanium and its alloys, cobalt-chrome alloys, stainless steel, silicone elastomers, polyurethanes, highly crosslinked polyethylene, and certain biopolymers and ceramics such as hydroxyapatite. Applications include dental implants, orthopedic implants, cardiovascular devices, catheter components, and tissue-engineering scaffolds. Some materials are designed to be resorbable and safely degrade in the body, while others are intended to remain in situ permanently.

Biocompatibility is context-dependent. A material that is biocompatible for short-term skin contact may not be suitable for implanted devices, and a safe material at one sterilization method (e.g., gamma irradiation) may exhibit different behavior after another (e.g., ethylene oxide). Regulatory approval requires documentation of biocompatibility testing and ongoing post-market surveillance.