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Biological evaluation in a regulatory context

Standard procedures for in vitro tests are based on uniform protocols that ensure reproducible and comparable results. These standards are defined by international organisations such as the International Organisation for Standardisation (ISO) or the Organisation for Economic Co-operation and Development (OECD). They provide guidelines for conducting tests, selecting suitable cell lines and analysing and documenting the results.

BioTeSys can support you with a variety of established assays:

  • Biocompatibility (ISO 10993)
    • Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009), non-GLP
    • Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021 / OECD TG 439), non-GLP
    • Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021), non-GLP
      • kDPRA (OECD TG 442C)
      • LuSens (OECD TG 442D)
  • In Vitro Skin Corrosion: Reconstructed Human Epidermis (Rhe) Test Method (OECD TG 431), non-GLP
  • Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2017)