Biocompatibility

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  • Pre-study of your dossier to guide you in your choice of testing strategy.
  • Expertise: risk analysis, Biological Risk Assessment, worst case strategy, evaluation of your dossier, interpretation of physico-chemical test results in accordance with ISO 10993-17.

Thanks to their compliance with Good Laboratory Practice (GLP) and current standards, the reports from these studies can also be used in the context of CE, FDA or Japanese marking…

Table I of ISO 10993-1 classifies medical devices according to the nature and duration of their contact with the human body, and lists the tests applicable to each type of medical device.

viTRO Medical Device Tests

Cytotoxicity – ISO 10993-5:

  • XTT staining
  • Red neuter absorption staining (NRU)
  • Colony formation test

Irritation – ISO 10993-23:

  • 3D Reconstructed epidermis

Hemocompatibility – ISO 10993-4:

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

Mutagenicity & Genotoxicity – ISO 10993-3:

  • Bacterial mutation-Ames mutagenicity
  • In vitro gene mutation tests on mammalian cells (L5178Y) (inspired by OECD 490)
  • Micronucleus test (CHO cells: Chinese hamster)
  • Chromosome aberration test (human lymphocytes)

Tests vivo Medical devices

Tolerance studies – Irritation – ISO 10993-23:

  • Acute and repeated skin and eye irritation (rabbit)
  • Intradermal, nasal, vaginal, anal, jugal (rabbit)

Tolerance studies – Sensitization – ISO 10993-10:

  • Sensitization studies: LLNA-BrdU (mouse) Magnusson & Kligman, Buehler (guinea pig)

Systemic toxicity – ISO 10993-11:

  • Acute or repeated oral and dermal toxicity Subacute – subchronic toxicity – chronic (rat)
  • Pyrogen test (rabbit)

Implantation studies – ISO 10993-6:

  • Subcutaneous, intraosseous, knee joint, muscle (rat)

Surgery and efficacy:

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