ISO 10993 1:2009

Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

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.