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ONORM 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)
This document lays down a framework for the identification and, where appropriate, quantification of the components of a medical device, which enables the identification of biological hazards and the estimation and control of the biological risks posed by component materials. A largely gradual approach to chemical characterisation is used, which may include one or more of the following steps: - the identification of the manufacturing materials (configuration of the medical device); - the characterisation of the manufacturing materials by identifying and quantifying their chemical components (material composition); - the characterisation of the medical device in relation to chemical substances introduced during manufacture (e.B. mold release agents, manufacturing-related impurities, sterilisation residues); - estimation (under laboratory extraction conditions) of the potential of medical ...
Austrian Standards Institute [on]