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Biocompatibility of Medical Devices, Cosmetics and Chemicals (ISO 10993)

The evaluation of the biocompatibility of medical devices is specified in the standard series DIN EN ISO 10993 and represents – according to the authorities – an absolute prerequisite prior to the performance of extensive animal studies. This situation is even stronger reflected for the evaluation of cosmetics and its compounds: here the EU Directive 76/768/EEC (Cosmetics Directive) provides the regulatory framework phasing out animal testing for cosmetics purposes across the EU. Moreover the Cosmetics Directive declared a marketing ban for cosmetic products and their ingredients in the EU when tested on animals. Even the reformation of the EU Chemicals Law by the REACH concept suggests the priorisation of non animal testing.

Recognising the importance of these guidelines MicroMol (accredited according to the ISO 17025 and ZLG) offers a professional in vitro platform for medical device testing according to the demands of the Medical Device Directive 93/42 / EEC (MDD) as well as for the testing of cosmetics, chemicals and substances generally involved in biological processes.

Biocompatibility testing in cellular in vitro systems:

  • Determination of cytotoxicity in vitro according to ISO 10993-5 / ISO 10993-12 (upon substance confrontation)
  • Determination of skin irritation according to the ISO 10993-10 (OECD TG 439)
  • Determination of skin corrosion according to the OECD TG 431
  • Determination of eye irritation according to the OECD TG 460 (Fluorescein leakage test)
  • Determination of the allergenic potential / sensitization of medical devices and substances in vitro according to ISO 10993-10 (Human Cell Line Activation Test : OECD TG 442E)
  • Testing for genotoxicity, carcinogenicity and reproductive toxicity: Mammalian Cell Gene Mutation Test ISO 10993-3: OECD TG 476; Micronucleus Test in CHO cells: OECD TG 487)

Biocompatibility testing with microbiological background:

  • Cleaning validation
  • Determination of sterility in the course of the validation of a sterilisation procedure (sterility validation / Determination of Bioburden (DIN EN ISO 11737-1)
  • Determination of the virucidal potential (DIN EN ISO 14476)
  • Microbiological examination of non-sterile products (2.6.12 Ph. Eur.)
  • Efficacy of antimicrobial preservation (2.5.333 Ph. Eur)
  • Microbiological testing of the production environment and materials
  • Testing for genotoxicity, carcinogenicity and reproductive toxicity: AMES Test (ISO 10993-3: OECD TG 471)
  • Pyrogen testing (Monocyte activation test according to the EP chapter 2.6.30)

 Additional: Stability testing:

  • Temperature stability
  • Light stability
  • Microbiological challenge testing (DIN EN ISO 11930)

 

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