Biocompatibility

viTRO Medical Device Tests

Cytotoxicity – ISO 10993-5:

  • XTT method
  • Neutral Red Uptake (NRU) method
  • Trypan Blue
  • Direct and indirect contact
  • Colony Forming Assay

Irritation – ISO 10993-23:

  • Irritation test on reconstructed human epidermis

Hemocompatibility – ISO 10993-4:

  • Hemolysis test: to determine the hemolytic properties of a medical device
  • PTT (Partial Thromboplastin Time) test: coagulation abnormalities
  • Complement activation tests (SC5b-9)
  • Platelet activation test (PF4)

Mutagenicity & Genotoxicity – ISO 10993-3:

  • Bacterial reverse mutation assay (Ames test)
  • In vitro gene mutation tests on mammalian cells (L5178Y) (inspired by OECD 490)
  • Micronucleus test on CHO cells
  • Chromosome aberration test (CHO or human lymphocytes)

Tests vivo Medical devices

Tolerance studies – Irritation – ISO 10993-23:

  • Acute and repeated skin and eye irritation (rabbit)
  • Intradermal tolerance test
  • Mucosal irritation test (nasal, vaginal, anal, buccal) (rabbit)

Tolerance studies – Sensitization – ISO 10993-10:

  • Sensitization studies: LLNA-BrdU (mouse)
  • Maximization test (Magnusson & Kligman)
  • Non-maximization test according to Buelher 

Systemic toxicity – ISO 10993-11:

  • Acute and repeated-dose toxicity via oral, dermal, intraperitoneal, intravenous, parenteral routes – subacute, subchronic, and chronic toxicity
  • Pyrogen test (rabbit) according to the USP, the European Pharmacopoeia, and the Japanese Pharmacopoeia

Implantation studies – ISO 10993-6:

  • Subcutaneous, knee joint, muscle

Surgery and efficacy:

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