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.
Subject(s)
Humans , Reproductive Techniques, Assisted , Toxicity TestsABSTRACT
Infertility has become a global problem affecting human reproductive health.As an important treatment for infertility, assisted reproductive technology has made great progress over the past few decades.Rapid development has also taken place in medical devices for human assisted reproductive technology.It is imperative to establish the risk management and safety evaluation system of these products.In 2016, the industry standard YY/T 1434-2016 Human in vitro Assisted Reproductive Technology With Medical Equipment in vitro Mouse Embryo Test was officially released.In this paper, the key notes and elements of this in vitro mouse embryo test are briefly reviewed.