无菌医疗器械包装运输性能的试验研究

Experimental Research on Shipping Performance of Sterile Medical Device Package

采用ASTM D4169运输容器和系统性能试验标准中的第13种流通周期,以一次性使用输注泵包装为例,按该流通周期的试验进程依次对该包装进行了人工搬运、运载堆码、无约束振动、低气压、运载振动、集中冲击和人工搬运试验。介绍了各试验进程的试验方法,可为医疗器械生产企业,检测机构等评价医疗器械包装承受运输环境能力时提供参考。

This study used the thirteenth distribution cycles in the standard of ASTM D4169. This research used the disposable infusion pump package as an example, the manual handling, vehicle stacking, loose-load vibration, low pressure, vehicle vibration, concentrated impact and manual handling were tested according to the test schedule of the distribution cycle. This paper introduces the test methods of various test schedules, which can provide references for medical device manufacturers and testing organizations to evaluate the capacity of medical device packaging to withstand transportation environment.