The reliability tests for biomedical devices: A review

In the quality of biomedical devices, mechanical properties, durability and biocompatibility are the three most concerned properties. Also, by failure modes analysis, the failure modes of biomedical devices can be mainly divided into thrombosis, infection, inappropriate healing, structural failure, adverse local tissue interactions, migration and systemic and miscellaneous effects. Each failure mode has negative effects on some (or all) of the quality properties. According to the tested quality properties, tests for biomedical devices can be summarized as mechanical tests and biological tests. Mechanical tests are used to test mechanical properties and durability while biological tests are used to test biocompatibility and durability. Different kinds of tests focus on studying different failure modes, in some ways, evaluating the reliability of biomedical devices from different angles. Based on reliability-centered systems engineering which focus on dealing with failure and the unique property of biomedical devices, i.e. biocompatibility, the concept of failure is extended and the clear definition of the reliability of biomedical devices is given.