In the chemical characterisation of materials for medical devices, components are recorded that can be released from the product.
Depending on the focus of the investigation, extraction agents and conditions are selected to determine extractable and leachable substances (extractables & leachables). Screening for chemical substances is carried out using gas chromatography (GC-MS), liquid chromatography (LC-qTOF) and inductively coupled plasma mass spectrometry (ICP-MS).
The test provides data for the biological assessment and evaluation of the toxicological hazard potential within the framework of risk management.
We offer the following tests in the accredited area and/or under GLP:
- Sample preparation according to DIN EN ISO 10993-12
- Screening for VOC from aqueous extract using GC-MS
- Screening for SVOC from aqueous, semi-polar and/or non-polar extract using GC-MS
- Screening for NVOC from aqueous, semi-polar and/or non-polar extract using HPLC-qTOF
- Screening for elemental components in the water extract using ICP-MS
- Screening for VVOC and VOC by means of thermodesorption (testing in the emission chamber)