7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in direct or indirect contact with the patient or user. (ii) Where bio-compatibility testing has been undertaken (as per prescribed standards) to characterize the physical, chemical, toxicological and biological response of a material, detailed information should be included on the tests conducted, standards applied, test protocols, the analysis of data and the summary of results. At a minimum, tests should be conducted on samples from the finished, sterilized (when supplied sterile) device. (iii) Depending on nature and intended use of the investigational medical device, device performance for its actions (including mechanical, electrical, thermal, radiation and any other of this type) and safety should be assessed in healthy or diseased animal model (intended to be treated by such medical device), as appropriate, demonstrating reaction to active and basic parts of the devices on absolute tissue, local tissue as well as whole organ, clearly recording local, general and systemic adverse reactions, risks or potential risks and performance of device in line with intended use. Wherever possible, histopathology, pathophysiology and path anatomy should be carried out. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 112 of 248 (iv) ISO-10993, Biological Evaluation of Medical Devices, should be followed for conducting bio-compatibility study for invasive medical devices should be carried out. A report of bio-compatibility study along with rationale for selecting specific tests carried out should be prepared including conclusion of the study.