Bio – toxicological tests

Laboratorio Tossicologico

Biocompatibility tests allow to evaluate the presence or absence of a potential biological risk connected with the use of the device on humans. The tests to be performed are established by the guiding standard UNI EN ISO 10993-1 and / or USP based on the type of devices, their invasiveness and the duration / type of contact with human tissues. The biocompatibility tests carried out are conducted in strict compliance with and in accordance with the specific standards identified for each type of test and according to the internationally recognized methodologies. Coronati Consulting is able to offer qualified support for the drafting of a detailed study program for each type of medical device.


For some of these tests, Coronati Consulting Lab collaborate with qualified, accredited and certified external laboratories.

List of tests

  • Biological evaluation of medical device according to ISO 10993-1
  • Cytotoxicity (ISO 10993-5)
  • Sensitization with GMPT method (ISO 10993-10)
  • Sensitization with LLNA method (ISO 10993-10)
  • Skin, ocular and mucosal irritation (ISO 10993-10)
  • Intracutaneous reactivity (ISO 10993-10)
  • Acute systemic toxicity (ISO 10993-11)
  • Subacute toxicity(ISO 10993-11)
  • Sub chronic toxicity (ISO 10993-11)
  • Pyrogen test (Farm. Eur. / USP / ISO 10993-11)
  • LAL test (Farm. Eur. / USP / ISO 10993-11)
  • Genotoxicity (Ames test, Micronucleus Test ) ISO 10993-3
  • Implantation test. muscular, subcutaneous, bone intraocular (ISO 10993-6)
  • Hemocompatibility (ISO 10993-4 / ASTM F756)

Chemical tests

Microbiological tests

Surgical masks tests

Bio-toxicological tests

Measuring laboratory

Packaging tests

Other tests