The addition of chemical laboratory tests to the biological test methods is a significant further development of the service portfolio in order to offer our customers from the medical technology sector a complete service package of accredited tests for the biocompatibility of medical devices from a single source. This also includes the requirement to include chemical laboratory tests as part of chemical characterization in accordance with DIN EN ISO 10993-18 in the scope of accreditation.
The assessment of the relevant chemical test methods has been successfully carried out by the responsible ZLG - Central Authority of the Federal States for Health Protection of Medicinal Products and Medical Devices - in the chemistry laboratory at the Leipferdingen site and the accreditation certificate has been extended to include the following test methods.
- Headspace GC-MS for volatile organic substances
- GC-MS for semi-volatile organic substances
- LC-HRMS for non-volatile organic substances
- ICP-MS for inorganic substances
Detailed information on chemical characterization according to DIN EN ISO 10993-18 and the test methods can be found here.