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ONORM EN ISO 10993-1:2021
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
This document lays down the following: - the general principles applicable to the biological assessment of medical devices within a risk management procedure; - the general classification of medical devices, based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - identifying gaps in the available data sets on the basis of a risk analysis; - the identification of additional data sets necessary for the analysis of the biological safety of the medical device; - the assessment of the biological safety of the medical device. This document applies to the assessment of materials and medical devices that are expected to come into direct or indirect contact with - the patient's body as part of the intended use, and/or - the user's body, if the medical device is intended for protection (e.g.B. surgical gloves, masks and a ...
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Austrian Standards Institute [on]