Xu Yun
Center for Medical Device Evaluation, NMPA, Beijing, 100081.
Zhongguo Yi Liao Qi Xie Za Zhi. 2024 Jul 30;48(4):457-460. doi: 10.12455/j.issn.1671-7104.240067.
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.
作为辅助生殖技术的直接微环境，人类辅助生殖技术用培养基的评价尤为重要。本文探讨了分类管理、技术审评要点、临床评价及审评思路，重点阐述了人类辅助生殖技术用培养基的基本要求、原材料控制、生物学评价、灭菌工艺，并结合部分物料限量、新增物料及质量体系控制，全面评估人类辅助生殖技术用培养基全生命周期的管理风险。
