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Biocompatibility of Medical Devices (DIN ISO 10993)

The evaluation of the biocompatibility of medical devices is specified in the standard series DIN EN ISO 10993 and represents – according to governmental rules – an absolute prerequisite prior to the performance of extensive animal studies.

MicroMols’ testing laboratory, which is accredited according to ISO 17025:2005 and DAkkS, offers a professional service for testing of medical devices according to Medical Device Directive 93/42 / EEC (MDD). In detail we offer the following test platform:

Biocompatibility testing with microbiological background:

  • Cleaning validation
  • Sterility validation
  • Determination of Bioburden according to ISO 11737-1
  • Microbiological testing of the production environment and materials
  • AMES test according to DIN EN ISO 10993-3
  • Endotoxin testing

Biocompatibility testing in cellular in vitro systems:

  • Testing for cytotoxicity according to DIN EN ISO 10993-5: 2009
  • Testing for skin / eye irritation and skin corrosion according to DIN EN ISO 10993-10
  • Determination of the allergenic potential (sensitization) of medical devices and substances (DIN EN ISO 10993-10)

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