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ANSI/AAMI/ISO 10993-1: 2018
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
This document specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of medical 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.
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Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]