With this year's assessment of our chemical laboratory in Leipferdingen, the essential test procedures for the chemical characterization of materials for medical devices have now been assessed by the ZLG (Central Office of the Federal States for Health Protection for Drugs and Medical Devices) and included in the scope of accreditation.
The addition of biological test methods with chemical laboratory tests is a significant further development of the service portfolio in order to offer our medical technology customers a complete service package of accredited tests of the biocompatibility of medical devices from a single source. This also includes the requirement to include chemical laboratory tests as part of chemical characterization according to DIN EN ISO 10993-18 in the scope of accreditation.
The assessment of the relevant chemical test methods was successfully carried out by the responsible ZLG - Central Office of the States for Health Protection for Drugs and Medical Devices - in the chemistry laboratory at the Leipferdingen site and the accreditation certificate was expanded to include the following test procedures.
- Headspace GC-MS for volatile organic substances
- GC-MS for semivolatile 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 .
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