Historical
DIN EN ISO 10993-18:2021
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020
This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through: - 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); - the estimation 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). This document may also be used for chemical characterization (e. g., the identification and/or quantification) of degradation products.
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Deutsches Institut für Normung [din]