Biocompatibility

Compatibility put to the test

 

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

We have the necessary expertise and offer appropriate in vitro tests. The relevant cells and culture conditions are applied according to the customer's specific requirements and the standard, in order to determine biocompatibility.

• 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 sensitization (ISO 10993-10), non-GLP
  • kDPRA (OECD TG 442C)
  • LuSens (OECD TG 442D)
• Release studies
• Organization and monitoring of GLP studies according to ISO 10993