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Medical devices

Your Partner for Preclinical Toxicology

Medical devices are assessed for biocompatibility as detailed in ISO10993. This is the accepted international standard which is used in conjunction with national requirements such as the United States Pharmacopeia (paragraphs 87 and 88). CiToxLAB has extensive experience of the biological testing necessary to comply with these standards.

The range of medical devices is very diverse, and we have successfully tested devices made from plastic, metal, ceramic, absorbent and biodegradable materials. The forms of devices we have tested include solids, creams, gels, liquids, fabrics, cements and adhesives.

Specific testing is recommended in the standards for each particular type of device and we offer the full range of required in vitro and in vivo biological tests. Whether you require testing of a finished device or assessment of raw plastic materials (USP Class I to VI) we can offer you the necessary packages.

The main current studies are listed below and we are always happy to discuss new projects.

In vitro cytotoxicity

  • Qualitative version with L929 cells that complies with both ISO10993-5 and USP (paragraph 87)

Sensitization

  • Local lymph node assay (LLNA)
  • Guinea pig maximization test (GPMT)

Irritation

  • Topical irritation (skin, buccal cavity, vagina, urethra, rectum)
  • Intracutaneous reactivity
  • Single or cumulative exposure in accordance with the intended clinical use

Genetic toxicology

  • Ames test (OECD 471)
  • Gene mutation test in mouse lymphoma cells (OECD 476)
  • Mouse micronucleus test (OECD 474) – for submissions to the US FDA

Systemic toxicity

  • Acute and repeated exposure, available with a wide range of dose routes in appropriate species

Implantation tests

  • Muscular or subcutaneous implantation in rabbits
  • Subcutaneous implantation in rats

Hemo-compatibility

  • In vitro hemolysis
  • In vitro coagulation

Carcinogenicity and reproductive toxicity

  • It is extremely rare that these test types are performed for medical devices. Our experience with these study types, when testing pharmaceuticals, enables us to perform them with medical devices if necessary.

Efficacy studies

  • The efficacy of certain types of medical devices can be assessed, for example in wound healing studies. Please contact us to discuss your requirements.