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Biocompatibility /

Biological Safety

TentaMedix provides a highly sophisticated and accredited in-vitro platform for testing of medical devices according to the DIN ISO 10993. We are skilled to test pharmaceuticals and biological active substances using cellular test systems according to international accepted guidelines.

 

Determination of cytotoxicity in-vitro

  • According to DIN ISO 10993-5 / USP <87>
  • Read out: XTT / Neutral red uptake (NRU) / MTT / MTS
  • Determination of photoxicity (OECD TG 432)

Skin irritation and sensitization in vitro

  • In vitro skin irritation on reconstructed human epidermis: ISO 10993-10 / 23 as draft / OECD TG 439)
  • ARE-Nrf2 Luciferase Test Method (Kerationsens assay): OECD TG 442d
  • Human Cell Line Activation Test (h-CLAT): OECD TG 442e
  • Skin corrosion in vitro (OECD TG 431)

Occular corrosion and irritation

  • Human Corneal Epithelium like Test: OECD TG 492
  • Fluorescein Leakage Test: OECD TG 460

    Genotoxicity

    • Bacterial Reverse Mutation Test (AMES-test): DIN ISO 10993-3 / OECD TG 471
    • In-vitro mammalian micronucleus test: DIN ISO 10993-3 / OECD TG 487

    Hemocompatibilty

    • DIN ISO 10993-4
    • Dynamic process using human whole blood in a closed loop system
    • Integrity of red blood cells: haemolysis / determination of total and plasma haemoglobin (HB)
    • Determination of complete blood composition (CBC)
    • Effects on coagulation: changes in total thrombocyte count, human platelet factor 4 (hPF-4), Prothrombin (PT), Fibrinogen (Fib), Thrombin time (TT), Thrombin / anti-Thrombin complex (TAT)
    • Activation of the immune system: determination of complement factors C3a, C5a, Sc5b-9

    Pyrogen Testing

    • Bacterial Endotoxin Testing (BET): Limulus Amoebocyte (LAL) Test  Ph. Eur. 2.6.14
    • Non Endotoxin Pyrogens (NEPs) Monocyte Activation Test (MAT): Ph. Eur. 2.6.30

    Bioburden and Sterility

    • Determination of Bioburden as well as the product specific recovery (ISO 11737-1, Ph. Eur 2.6.12), validation and product testing
    • Test of sterility performed within a sterilization process (ISO 11737-2, Ph. Eur. 2.6.12), validation and product testing
    • Direct inoculation or rinsing of test item

      Chemical characterization

      TentaMedix’s platform of medical device testing according to ISO 10993  is supplemented by the chemical characterization of test items and the determination of Leachbales & Extractables by sophisticated Chromatography / Mass Spectroscopy (LC-MS, GC-MS, HS-GC-HS. ICP-MS) according to the DIN ISO 10993-13/14/15/17/18. In addition Tentamedix offers a platform for proper generation of extracts from medical devices (ISO 10993-12).

      Chemical characterization and the leachables / extractables testing is performed by our accredited partner labs within the Tentamus network.

      Biocompatibility in-vivo

      In addition to our in-vitro testing platform we offer – when claimed – the determination of biological reactivity  in-vivo, in detail

      • ISO 10993-2 – Animal welfare regulations
      • ISO 10993-6 – Determination of local effects upon implantation
      • ISO 10993-11 – Determination of systemic toxicity
      • ISO 10993-20 – Principles and methods of immune toxicology

      The in-vivo tests are performed by qualified partner laboratories.

      TentaMedix is GMP certified and accredited according to the ISO 17025. We offer a professional service for testing of medical devices according to Medical Device Directive 93/42 / EEC (MDD).

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