Biocompatibility

Compatibility put to the test

The Medical Devices Act covers a wide variety of products. It requires a flexible approach and in-depth knowledge of the prescribed tests to ensure implementation in accordance with DIN EN ISO 10993.

We have the necessary expertise and offer relevant in vitro tests. The respective cells and culture conditions are applied according to the specific requirements of the customer and the standard to determine biocompatibility.

• 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), non-GLP
  • kDPRA (OECD TG 442C)
  • LuSens (OECD TG 442D)
• In vitro skin corrosion (OECD TG 431), non-GLP
• Release analysis
• Arrangement and monitoring of GLP studies according to ISO 10993