DS/ISO 10993-1:2018

This part document 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.