This part of ISO 10993 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.
