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.
Revises
ISO 10993-1:2003
WITHDRAWN
ISO 10993-1:2009
95.99
Withdrawal of Standard
Aug 17, 2018
Corrected by
ISO 10993-1:2009/Cor 1:2010
PUBLISHED
ISO 10993-1:2018
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