Biocompatibility and Devices

CBI offers comprehensive biocompatibility testing — in compliance with ISO-10993, ISO-9394 and US Pharmacopeial Convention and Code of Federal Regulations standards — in a rapid and cost-effective manner.

In Vivo Assays

  • Acute, systemic, subacute, chronic and carcinogenicity toxicity studies
  • Beuhler, Draize and Magnussen-Kligman maximization testing
  • Biocompatibility
  • Bone, joint,  and orthopedic
  • Contact lens testing, ISO-9394
  • Device-drug combinations
  • Device-stem cell combinations
  • Dermal, ocular, mucosal irritation testing
  • Bone, joint, and orthopedic
  • Long-term surgical implantation studies
  • Muscle, bone, subcutaneous and intradermal implantation
  • Topical, intracutaneous, ocular and primary skin irritation testing
  • Pyrogenicity testing

CBI has conducted numerous studies related to dural, amnionic, pericardial and other patches, coated films, sutures, matrices, osteoinduction materials, cartilage regeneration, morselized bone, spinal fusion, bone regeneration and tendon repair. These studies are often customized or unique experiments.

Safety Pharmacology Assays

  • Safety Pharmacology: Irwin, respiratory, cardiovascular intravenous irritation, CNS

In Vitro Assays

  • Blood compatibility testing (hemocompatibility)
  • Cytotoxicity testing (Agar overlay and MEM elution)
  • Other in vitro assays

Have any additional questions? Contact us today!