Medical Devices

VUOS has long experience with biological evaluation of medical devices. All tests are performed in Quality Assurance System (GLP - Good Laboratory Practice) according to the European Standard EN ISO 10993.

  • Tests for in vitro cytotoxicity: EN ISO 10993-5, EN ISO 10993-12
    • Test by direct contact, test on extracts
  • Tests for local effects after implantation: EN ISO 10993-6, EN ISO 10993-12 
  • Tests for irritation and delayed-type hypersensitivity: EN ISO 10993-10, EN ISO 10993-23, EN ISO 10993-12
    • In vitro tests, LLNA and guinea pig maximization test, ¨
    • in vitro skin irritation, in vivo intracutaneous reactivity, in vivo mucosal/ vaginal/ penile/ rectal irritation
    • BCOP, in vitro eye irritation,
  • Tests for systemic toxicity: EN ISO 10993-11, EN ISO 10993-12
    • Acute toxicity, subacute toxicity, subchronic toxicity – dual route of parenteral administration
  • Tests for interaction with blood (haemocompatibility): EN ISO 10993-4, EN 10993-12
    • Coagulation, Platelet activation, Haematology, Thrombosis ex vivo
  • Tests for genotoxicity , carcinogenicity and reproductive toxicity: EN ISO 10993-3, EN ISO 10993-12
    • AMES, in vitro mammalian cell micronucleus, in vivo erythtocyte micronucleus test