Prior to the production of Medical Devices, material selection and risk analysis is an important part of the design process for medical devices.
With the revision to iso 10993-1 standard, it is stated that in the risk assessment process, the definition of chemical components of direct and indirect contact medical devices and material characterization, including chemical characterization, should be carried out.
ISO 10993-18 Biological evaluation of medical devices – part 18: Determination of the chemical properties of materials.
Chemical characterization will be taken into account with appropriate toxicological evaluation to determine whether further tests are 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 evaluation of the device and the toxicological risk assessment.