Chemical characterization of medical devices by ISO 10993-18

Chemical characterization by the ISO 10993-18 standard is performed to identify the constituents of a medical device and to estimate and control the risks associated with its chemical composition. The test is a key part of assessing the biocompatibility of medical devices.

Chemical characterization includes the estimation of substances released under simulated or exaggerated laboratory conditions (extractables) or the detection of actually released substances (leachables) by the medical device during clinical use. Applicable methods may include HS-GC (volatile organic compounds), GC-MS (semi-volatile organic compounds), LC-MS (non-volatile organic compounds), and ICP-MS (inorganic elements). Suitable tests, solvents, and analysis methods should be chosen according to the device's composition, intended contact time, and site.

The tests are always customized for the product. Any chemicals detected above the concentrations established to be safe require further evaluation, typically through toxicological risk assessment (ISO 10993-17).

Suitable sample matrices
Medical devices
Available quality systems
Accredited test method, GLP test method

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