[Considerations on in vitro and in vivo magnetic nanoparticles hemocompatibility testing]

The aim of this paper is to summarize few aspects and underline some difficulties that hemocompatibility testing come up. The purpose of hemocompatibility testing is to look for possible undesirable changes in the blood caused directly by a medical device, by chemicals leaching from a device or biomaterials. Undesirable effects of device materials on the blood may include alterations in coagulation parameters, thrombus formation, hemolysis, and immunological changes. For each different event the literature is rich in showing tests, not different in principle, but in testing conditions. ISO 10993-4 describes hemocompatibility tests in five different categories (thrombosis, coagulation, platelets, hematology, and immunology). Here we put together the tests that ISO 10993 and/or American Society for Testing and Materials (ASTM) suggest to evaluate hemocompatibility and we emphases on their utility for magnetic nanoparticules testing. The individual tests are not discussed in detail; they may be performed either in vivo or, preferably, in vitro. For each test we made few considerations with criticism. There is still some uncertainty with respect to what is actually required by the regulatory authorities for the hemocompatibility test, and there is still no harmony between ASTM and ISO 10993 regulations regarding some aspects to be standardised.