[Embryonic Toxicity Test of Medical Devices for Human Assisted Reproductive Technology].

ABSTRACT

OBJECTIVE: To introduce the test methods of embryo toxicity applied to medical devices for human assisted reproductive technology (ARTMD), and provide the evaluation reference. METHODS: The embryo toxicity test methods of ARTMD were summarized, and the key procedures and challenges in their safety evaluation were also discussed. RESULTS: Establishing sensitive and stable test system is important to guarantee the safety and efficacy of ARTMD. CONCLUSIONS: It remains development opportunities in improving sample preparation, extending test technology and expending evaluation method.