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.