The reason a biocompatibility test is performed is to determine the effectiveness and durability of a biomaterial, medical device or drug for human use and to analyze any potentially harmful or physiological side effects. To prevent insufficiently tested materials and devices from entering the market, governments around the world have established medical device regulatory organizations. One such body is the International Standards Organization (ISO). The ISO 10993 standard gives the basic guidelines for biocompatibility and its testing. Subdivisions of this standard specify which tests need to be performed for hazard identification on biomaterials and devices – these tests include genotoxicity, carcinogenicity and reproductive toxicity. Additionally, for pre-clinical research, the ISO 10993-2 standard identifies specific animal welfare requirements that need to be met for all animals used in animal tests to analyze the biocompatibility of biomaterials. The amount and type of compatibility tests performed would depend on if the biomaterial is to be implanted, use on the skin or surface, or if its part of a communication device. Regardless of where it is placed, there are three factors that all biomaterials are checked for – cytocompatibility evaluation, sensitization, and irritation or intracutaneous reactivity.