ISO 10993-5 | Bioscience Labs

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 mammalian cells in-vitro using appropriate biological parameters. 

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In-Vitro Testing 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 our…

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