Chemical characterization of medical devices according to DIN EN ISO 10993-18
Chemical characterization as the basis for biocompatibility assessment
Based on the risk assessment according to DIN EN ISO 10993-1, the chemical characterization according to DIN EN ISO 10993-18 is an essential part of the biocompatibility assessment of medical devices. The aim is to identify and quantify chemical substances that may pose potential hazards. The focus is on chemical substances from materials, auxiliary and operating materials, packaging or cleaning and sterilization.
The chemical substances are extracted from or into the product under simulated extraction conditions (Leachables) or intensified respectively exhaustive conditions (Extractables) - as specified by the manufacturer - in accordance with DIN EN ISO 10993-12, and the substances are analyzed using suitable chromatographic and spectroscopic analysis methods.
The results of the analysis with the qualitatively and quantitatively determined substances then form the basis for the toxicological evaluation to be carried out subsequently in accordance with DIN EN ISO 10993-17.
Typical materials / process auxiliaries | Characteristic | Analysis method |
Solvent residues (isopropanol, acetone, hexane), monomers in polymers, plasticizers | Volatile Organic Substances | Headspace GC-MS |
Plasticizers, antioxidants, siloxanes, lubricating oils, mold release agents | Semivolatile organic substances | GC-MS |
Detergents, plasticizers, antioxidants, siloxanes | Non-volatile organic substances | LC-HRMS |
Elemental impurities from alloys, pigments, abrasives (e.g. aluminum, lead, chromium, cobalt, nickel, titanium, zinc) | Anorganic substances | ICP-MS |
Further information
This service does not fall within the scope of accreditation and also not the recognition on the part of ZLG and GLP of the biological laboratory of CleanControlling Medical GmbH & Co. KG in Liptingen. The tests are performed in cooperation with the accredited chemistry laboratory of CleanControlling Medical GmbH & Co. KG in Leipferdingen. Detailed information on the scope of accreditation of the chemistry laboratory in Leipferdingen can be found here.
You can also find detailed information on test procedures and test standards in our Infothek.
If you have any questions, the employees from our sales team will be happy to help you.
Newsletter registration
You find more information about our medical newsletter here!