二类含壳聚糖敷料的生物学评价实例及探讨

Biological Evaluation Examples and Exploration of ClassⅡChitosan Dressings

二类含壳聚糖敷料作为创面敷料中的一类产品,包括含壳聚糖、改性壳聚糖不同结构形态和临床预期用途的产品。作为与创面直接接触的医疗器械产品,在注册申报过程中进行生物学评价是必不可少的环节。通过对二类含壳聚糖敷料产品的实例分析,探讨在注册技术审评中运用标准GB/T16886.1-2022《医疗器械生物学评价第1部分:风险管理过程中的评价与试验》进行评价的问题,为相关产品研发、注册及审评提供参考。

As a type of wound dressing,ClassⅡchitosan dressings include chitosan and modified chitosan,as well as products with different structural forms and clinical expected uses.As a medical device product that comes into direct contact with the wound,conducting biological evaluation is an essential step in the registration and application process.By example analysis of classⅡchitosan dressings,this study explores the application of GB/T 16886.1-2022“Biological Evaluation of Medical Devices-Part 1:Evaluation and Testing in Risk Management Process”in registration technical review,providing reference for the development,registration,and evaluation of related products.