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ANSI/AAMI/ISO 10993-1:2009 (R2013)

Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process

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 analyze the biological safety of the medical device; the assessment of the biological safety of the medical device.

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Association for the Advancement of Medical Instrumentation [AAMI]


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