NF EN ISO 10993-18:2020
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The latest, up-to-date edition.
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
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English - French
05-01-2020
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following: the identification of its materials of construction (medical device configuration); the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition); the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
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