Medical Device Biocompatibility Test

Biological Evaluation According to ISO 10993-1 & ISO 14971

Biological evaluation of a medical device shall be conducted within a risk management process acc. to ISO 14971. This involves the identification of biological hazards, the estimation of the associated biological risks, the determination of their acceptability and the implementation of risk control measures (ISO/FDIS 10993-1:2025). Biological evaluation shall consider both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle.