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DIN EN ISO 10993-18:2021 Edition

DIN EN ISO 10993-18:2021 Edition

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Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process

Published By Publication Date Number of Pages
DIN 2021-03 83
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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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DIN EN ISO 10993-18
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