Given the completion of mechanical testing (e.g., compression, pull-out, etc.), this inquiry questions whether a cytotoxicity test using the MTT assay alone is adequate for assessing material suitability prior to implantation.
Hello Zatul Faqihah Salaha
Besides the cytocompatibility test (MTT, a minimum of four concentrations of the test material are tested), you need to carry out tissue compatibility evaluation which consists of tests that estimate the local irritation potential of material using sites such as skin or mucous membranes, usually in an animal model. The route of exposure (skin, eye, mucosa) and duration of contact should be analogous to the anticipated clinical use of the particular material.
There are a few tests which you could perform.
The Intracutaneous Test: extracts of the test material and blanks are injected intradermally. The injection sites are scored for erythema and edema (redness and swelling). This procedure is recommended for those materials that will have internal contact with the body or body fluids. It will help detect the potential for local irritation due to chemicals that may get extracted from the biomaterial.
The Primary Skin Irritation Test: should be considered for topical devices that have external contact with intact or breached skin.
Mucous Membrane Irritation Test: recommended for devices that will have contact with natural channels or tissues.
You would also need to carry out hemocompatibility evaluation which evaluates material - blood interaction. The tests used for evaluation of blood compatibility are classified into five categories according to the process or system being tested such as thrombosis, coagulation, platelets and platelet function, hematology and immunology.
The biomaterial for in vivo implantation should be non-toxic. It should be biocompatible meaning its ability to co-exist and perform with a natural substance in a specific biological application.
For more information, I have attached a link below which you would want to refer.
https://nhsrcindia.org/sites/default/files/Biomadical%20Equipment%20Management%20%26%20Maintenance%20Programe.pdf
Best.
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