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Human Egg Maturity Assessment and Its Clinical Application
Published on: August 19, 2019
[Thoughts on Evaluation of Culture Medium for Human Assisted Reproduction Technology]
1Center for Medical Device Evaluation, NMPA, Beijing, 100081.
Abstract:
As the direct microenvironment of assisted reproductive technology, the evaluation of culture medium for human assisted reproduction technology is particularly important. This paper discussed the classification management, technical review points, clinical evaluation and review thinking, focusing on the basic requirements, raw material control, biological evaluation, sterilization process of culture medium for human assisted reproduction technology, combined with some material limit, new added material and quality system control to thoroughly assess management risk of the whole life cycle of culture medium for human assisted reproduction technology.

