95.99 Withdrawal of Standard Aug 17, 2018
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
International Standard
11.100.20 Biological evaluation of medical devices
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.
WITHDRAWN
ISO 10993-1:2003
WITHDRAWN
ISO 10993-1:2009
95.99
Withdrawal of Standard
Aug 17, 2018
WITHDRAWN
ISO 10993-1:2009/Cor 1:2010
PUBLISHED
ISO 10993-1:2018