ISO 10993-1:2009 describes:
the general principles governing the biological evaluation of medical devices within a risk management process
the general categorization of devices based on the nature and duration of their contact with the body
the evaluation of existing relevant data from all sources
the identification of gaps in the available data set on the basis of a risk analysis
the identification of additional data sets necessary to analyse the biological safety of the medical device
the assessment of the biological safety of the medical device.