Material selection and risk analysis before the production of medical devices is an important part of the design process for medical devices.
With the revision to the ISO 10993-1 standard, it is stated that in the risk assessment process, the definition of the chemical components of direct and indirect contact medical devices and material characterization, including chemical characterization, should be performed.
ISO 10993-18 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Chemical characterization with an suitable toxicological assessment will be taken into account to determine whether further testing is required (ISO 10993-17 and ISO 10993-18). Based on the proposed revisions, the chemical characterization of a medical device provides the necessary data for the biological assessment and toxicological risk assessment of the device.
