DS/EN ISO 10993-18:2020/A1:2023

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).