The nearly equiatomic nickel-titanium (NiTi) alloy is known for its shape memory properties. These properties can be put to excellent use in various biomedical applications, such as wires for orthodontic tooth alignment and osteosynthesis staples. The aim of this study was to evaluate the short-term biological safety of the NiTi alloy. We carried out an end-point dilution minimal essential medium (MEM) extract cytotoxicity test, a guinea-pig sensitization test and two genotoxicity tests: the Salmonella reverse mutation test and the chromosomal aberration test. The NiTi alloy showed no cytotoxic, allergic or genotoxic activity, similar to the clinical reference control material AISI 316 LVM stainless steel. This promising biological behaviour was most likely due to a minimal release of ions and in that way a reflection of the good corrosion resistance of the NiTi alloy. Given these very good results, together with the good tissue compatibility as shown in several implantation studies in the literature, the NiTi alloy can be regarded as a biologically safe implant material with many promising clinical applications.