AAMI/ISO 10993-1:2018

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 04/27/2020

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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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