Is Mouse Embryo Assay Required For Consumable Products For In Vitro Assisted Reproduction (except The Fluid For In Vitro Assisted Reproduction)?


2023-01-10

 The consumables for in vitro assisted reproduction (except the fluid for in vitro assisted reproduction) act on gametes, zygotes, and embryonic cells at different developmental stages. Therefore, in addition to routine biological evaluations, in vitro mouse embryo assay should be performed with reference to YY/T 1434 for such products. Because the results of mouse embryo assay are an important indicator for evaluating the safety of such products, according to the industry requirements and requirements of clinical assisted reproduction for such products, mouse embryo assay should be used as a routine quality control item for such products.