一次性脊柱手术内固定器械包的无菌屏障系统有效性研究  

Effectiveness Research of Sterile Barrier System for Disposable Spinal Surgery Internal Fixation Instrument Package

作　　者：张立志 白冠玉 张志成[1] ZHANG Li-zhi;BAI Guan-yu;ZHANG Zhi-cheng(Department of Orthopaedics,the Seventh Medical Center of Chinese PLA General Hospital,Beijing 100700;Shanghai Ruizhi Medical Equipment Co.,Ltd.,Shanghai 201100)

机构地区：[1]解放军总医院第七医学中心骨科,北京100700 [2]上海锐植医疗器械有限公司,上海201100

出　　处：《中国医疗器械信息》2024年第10期1-5,共5页China Medical Device Information

基　　金：项目编号:LB20201A030019。

摘　　要：目的:检测模拟野外条件下一次性脊柱内固定器械包的无菌状态维持情况。方法:结合医疗器械运输验证ASTM D4169标准,模拟野战条件下医疗器械运输,由苏州富港工业检测技术有限公司对样品外箱、内包装盒、单包装及内部样品进行检测。通过对加速老化前后的试验样品进行无菌试验、目力检查、真空泄漏试验、染料渗漏试验、微生物屏障性能测试、密封强度和胀破试验来评价该试验样品无菌屏障系统的有效货架周期。结果:经检测样品外箱轻微变形,未出现破损;内包装盒、单包装及内部样品外观正常,未出现破损。经检测无菌屏障系统内产品在加速老化前后均保持无菌状态;在放大镜下目视检查整个封口区域的完整性、均匀性及有无贯通整个封口的通道;该试验样品加速老化前后均未发生泄漏;均无染料渗透无菌屏障系统封口;微生物屏障性能测试结果满意;包装的密封强度合格;胀破试验试验合格。结论:在本试验条件下,该试验样品无菌屏障系统能保证5年的有效货架周期。Objective:To test the sterile status maintenance of disposable spinal internal fixation instrument packages under simulated field conditions.Methods:Combined with the validation of ASTM D4169 standard for medical device transportation,simulate the transportation of medical devices under field conditions,and have Suzhou Fugang Industrial Testing Technology Co.,Ltd.test the outer box,inner packaging box,single packaging,and internal samples of the samples.Evaluate the effective shelf life of the sterile barrier system of the test sample before and after accelerated aging by conducting aseptic testing,visual inspection,vacuum leakage testing,dye leakage testing,microbial barrier performance testing,sealing strength and swelling test.Results:After testing,the outer box of the sample was slightly deformed and there was no damage.The appearance of the inner packaging box,single packaging,and internal samples was normal and there was no damage.After testing,the products inside the sterile barrier system remain sterile before and after accelerated aging;Visually inspect the integrity and uniformity of the entire sealing area under a magnifying glass,as well as whether there is a passage that runs through the entire sealing area;The test sample did not leak before and after accelerated aging;No dye penetration sterile barrier system sealing;The microbial barrier performance test results are satisfactory;The sealing strength of the packaging is qualified;The burst test is qualified.Conclusion:Under the conditions of this experiment,the sterile barrier system of the test sample can ensure an effective shelf life of 5 years.

关 键 词：一次性手术工具 脊柱内固定系统 无菌屏障 

分 类 号：R683.2[医药卫生—骨科学]