Chemical characterization according to DIN EN ISO 10993-18 - Test methods in the future scope of accreditation

Medical

Following the successful integration of the chemical laboratory into the business areas of CleanControlling Medical GmbH & Co. KG, a significant milestone was reached with the assessment of the test procedures for the chemical characterization of materials for medical devices by the ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten).

The addition of chemical laboratory tests to the biological test methods is an essential further development of the service portfolio in order to offer our medical technology customers 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 laobor tests within the scope 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 at the end of October by the ZLG - Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprotukten - in the chemistry laboratory at the Leipferdingen site. After allocation of the formal accreditation certificate, the following tests fall within the scope of accreditation: 

  • 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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