NEN-EN-ISO 10993-18:2020
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Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
Hardcopy
English
06-01-2020
NEN-EN-ISO 10993-18 specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and theestimation 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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