Test standards on cytotoxicity & biocompatibility

  • DIN EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system

  • DIN EN ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

  • DIN EN ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

  • USP 38 <87> Biological reactivity tests, in vitro.