Biocompatibility and standardization procedures

Testing in a regulatory environment

Standard procedures for in vitro tests are standardized protocols that ensure results are reproducible and comparable. These standards are defined by international organizations such as the International Organization for Standardization (ISO) and the Organisation for Economic Co-operation and Development (OECD). They provide guidelines for carrying out tests, selecting suitable cell lines, and analyzing and documenting the results.

Biotesys can support you with a wide range of established assays:

Biocompatibility according to ISO 10993

• In vitro cytotoxicity (ISO 10993-5), non-GLP
• In vitro skin irritation (ISO 10993-23/ OECD TG 439), non-GLP
• In vitro skin corrosion (OECD TG 431), non-GLP
• In vitro sensitisation (ISO 10993-10), non-GLP
  • kDPRA (OECD TG 442C)
  • LuSens (OECD TG 442D)
• Determination of the physical compatibility of contact lens care products and eye drops with contact lenses in accordance with ISO 11981