Biological evaluation of medical devices. Part 1, evaluation and testing within a risk management process / International Organization for Standardization / International Organization for Standardization
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
