regulatory standards

As an organization offering CRO (Contract Research Organization) services we have expertise in navigating and interpreting various standards associated with testing, for example:

  • ISO 10993-4: Blood compatibility of biomaterials.
  • ISO 10993-5: Biocompatibility of biomaterials, e.g., cytotoxicity (indirect and direct).
  • ISO 10993-22: Guidance on nanomaterials
  • ISO 10993-19: Physico-chemical, morphological and topographical characterization of biomaterials.
  • ASTM E3161-18: Standard Practice for Preparing a Pseudomonas aeruginosa or Staphylococcus aureus Biofilm using the CDC Biofilm Reactor
  • ASTM E2871-19: Standard Test Method for Determining Disinfectant Efficacy against Biofilm Grown in the CDC Biofilm Reactor using the Single Tube Method