AAMI/ISO 10993-1:2009/(R)2013 PDF

ISO 10993-1 describes the general principles governing the biological evaluation of medical devices within a risk management framework; 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 analyze the biological safety of the medical device; and the assessment of the biological safety of the medical device.

ANSI :	ANSI Approved
ISBN(s) :	1570203709
Number of Pages :	38
Published :	09/03/2009
Same As :	AAMI/ISO 10993-1:2009/(R)2013