To Study the Bio-compatibility of a brand new bio-material of which our device or product has been made, I will use ISO 10993-1 Test Matrix to determine what kind of test I should perform. And the decision of the test’s I should perform on my product is completely based on the use of my product, for example where in the body my product will be used, The surface of the device will be in contact with the skin or muscles and etc. So for example if I use this brand new bio-material to make a product which is an implant then I have to perform this test’s in reference to different categories my device fall in, for example the device will be in contact of tissue/bone or blood then the device will be implanted in the body for prolong, limited or permanent. And there are some test mentioned ISO 10993-1 which is mandatory to perform for before clinical trials regardless of the use of the bio-material like Cytotoxicity, sensitization and Irritation. The test marked on ISO 10993-1 chart with the red cross are mandatory to perform and the test marked with a blue dot are optional.
As I said before these tests will be completely depend on the intended application of our material, for example if we use this material for some implant orthopedic application then we have to perform the test listed in the third category OF ISO 10993-1 some of the test we will perform in case are cytotoxicity, sensitization, Genotoxicity, chronic toxicity and carcinogenicity. On the other hand if I use this material to make a stent which will come in contact with a soft tissue and a circulating blood in this case I have to perform some additional testing to check the bio-compatibility of my product like Systemic Toxicity, Irritation, Sub-Chronic Toxicity(if it is Permanent use), Genotoxicity and Hemocompatibility.