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 (extractables and leachables) released 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), but suitable tests should be chosen depending on the device.
The tests are always customized for the product.
- Suitable sample matrices
- Medical devices
- Available quality systems
- Accredited test method, GLP test method