标准科学Issue(2)：70-74,80,6.DOI:10.3969/j.issn.1674-5698.2024.02.012
医疗器械包装运输测试标准应用对比分析
Comparative Analysis of Transport Packaging Standards for Medical Devices
摘要
Abstract
This paper focuses on the application of medical device packaging and its transportation performance testing.It systematically analyzes the similarities and differences in domestic and international standards for the transportation of medical device packaging,providing technical solutions for the validation of the transportation stability of medical devices.The paper compares and analyzes the applicable scope and test item differences among the International Safe Transit Association(ISTA),the United States,Chinese national standards,and pharmaceutical industry standards.Taking a medical device packaging unit with a weight of 50 kg as an example,the study examines the equivalences and variances in temperature and humidity conditions,low air pressure,vibration,impact and stacking parameters during transportation testing.The paper identifies key considerations for packaging transportation testing of electrical,sterile and China-US dual-report medical devices,offering technical support for the whole life cycle supervision of medical devices.关键词
医疗器械/包装/运输稳定性/标准对比分析Key words
medical device/package/transport stability/standards comparative analysis引用本文复制引用
刘姗姗,冯智劼,李学洋,张闯,李涛..医疗器械包装运输测试标准应用对比分析[J].标准科学,2024,(2):70-74,80,6.基金项目
本文受国家质量基础设施(NQI)重点研发计划(项目编号:2021YFF0602502)资助. （NQI）
