ISO 10993-5

ISO 10993-5

Biological Evaluation of Medical Devices

This test method describes methods to assess the in-vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion:

  • with extracts of device, and/or
  • in contact with a device.

These methods are designed to determine the biological response of mammailan cells in-vitro using appropriate biological parameters. 

Labs
Services

In-Vitro Laboratory

Scientists in our In-Vitro testing labs are well trained on ASTM, AATCC, AOAC, CLSI, and EN standard methods. The efficacy testing services of this laboratory include MIC/MBC, biofilm prevention and removal, time-kill kinetics, clean room disinfectant validation, zone of inhibition and custom efficacy studies for disinfectants, antimicrobials and other products requiring EPA registrations and FDA 510(k) submissions. Studies in…

Learn More