一次性手术医疗器械包装封口浅析

Procedure analysis of Single use surgical instruments packaging heat sealing

本文阐述了医疗器械的常用灭菌方法及包装形式,并对包装材料及灭菌关系进行了简单分析,借助一次性手术医疗器械的实际包装封口情况,对无菌屏障评估及封口工艺的过程确认方案和过程验证的方法进行介绍。

Packaging type、sterilization method and sealing process of introduction,talk about compatibility of the packaging materials with sterilization.Introduction from the microbial barrier evaluation process from European Standard.Share the actual case for the management of packaging sealing.