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 are chosen according to the device's composition, intended contact time, and site.
We provide a range of chemical characterization tests based on the market area (MDR, FDA) and quality requirements (GLP).
The tests are always customized for the product. Any chemicals detected above the concentrations established to be safe require further evaluation, typically through a toxicological risk assessment (ISO 10993-17).
The starting price is based on the chemical characterization of volatile organic compounds (GLP, FDA).
More information about the method:
GC-MS analysisIon chromatography (IC)LC-MS analysis (LC-MS)TD-GC-MS analysisICP-MS analysis- Suitable sample matrices
- Medical devices
- Available quality systems
- Accredited testing laboratory
- Standard
- Method expert
Price
We also charge a 97 € service fee per order.
Large batches of samples are eligible for discounts.
Questions? We're happy to help.
Questions? We're happy to help.
Business hours: Mon–Fri 9 AM – 5 PM Finnish time (EST/EEST)
Other tests we offer
Cleaning validation of medical devices by ISO 17664
Irritation testing by ISO 10993-23
Face mask tests according to EN 14683 for type II and type IIR masks
Biocompatibility evaluation of breathing gas pathways by ISO 18562
Genotoxicity - Bacterial reverse mutation test (AMES)
Pyrogenicity testing by ISO 10993-11
Sterility test by ISO 11737-2: Aerobic bacteria, anaerobic bacteria and fungi
Ethylene oxide (EO) sterilization and sterilization residues by ISO 10993-7
Biological evaluation plan (BEP)
Hemocompatibility testing by ISO 10993-4
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