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/AAMI/ISO 10993-1:2009 history
1970ANSI/AAMI/ISO 10993-1:2018 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
2009ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process