ONORM EN ISO 10993-1:2011

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version) (Austrian Standard)

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.

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Austrian Standards Institute [on]