NF EN ISO 10993-1:2020
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The latest, up-to-date edition.
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
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01-12-2020
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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