Biological assessment, or biocompatibility testing, of medical devices is a mandatory part of the conformity assessment of such products.
Standard EN 10993 specifies safety assessments with respect to biocompatibility and biological risks of medical devices. This document specifies:
— the general principles governing the biological evaluation of medical devices as part of a risk management process.
— the general categorisation of medical devices based on the nature and duration of their contact with the body.
— the assessment of existing relevant data from all sources.
— the identification of gaps in the available data based on a risk analysis.
— the identification of additional data needed to analyse the biological safety of the medical device.
— the biological safety assessment of the medical device.