Accredited test methods for chemical characterization according to DIN EN ISO 10993-18

11/01/2022 Medical

With this year's assessment of our chemical laboratory in Leipferdingen, the main test methods 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 with regard to Medicinal Products and Medical Devices) and included in the scope of accreditation.

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.

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