摘要
随着经济发展和技术进步,越来越多的动物源性补片产品应用于组织和器官修复替代的医学领域。动物源性补片由于结构组成和生产工艺的复杂性,其在实际应用中仍存在力学强度不足、降解速率快、有害可沥滤物检出等问题。其中,产品生产工艺是影响产品质量的关键要素。该文重点综述了目前国内动物源性补片的生产工艺和质量控制的关键点,以期为该类产品的质量控制和监督管理提供新思路。
With the development of the economy and technological progress,more and more animal-derived mesh products are being utilized in the medical field for tissue and organ repair and replacement.Owing to the complexity of their structure and production process,these animal-derived meshes still face several challenges in practical applications,such as insufficient mechanical strength,rapid degradation rates,and the detection of harmful leachable substances.Among these challenges,the production process is a key factor affecting product quality.This paper reviews the key aspects of the production process and quality control for animal-derived meshes in China,offering new insights for the quality control and regulatory oversight of such products.
作者
赵丹妹
李崇崇
俞兰
刘丽
黄元礼
柯林楠
ZHAO Danmei;LI Chongchong;YU Lan;LIU Li;HUANG Yuanli;KE Linnan(National Institutes for Food and Drug Control,Beijing,102629;Chongqing Quality Testing&Inspection Centre for Medical Devices,Chongqing,400799)
出处
《中国医疗器械杂志》
2024年第5期573-579,共7页
Chinese Journal of Medical Instrumentation
关键词
动物源性补片
生产工艺
质量控制
脱细胞
残留溶剂
animal-derived meshes
production process
quality control
decellularization
residual solvent