Comparative Analysis of Transport Packaging Standards for Medical Devices
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.
medical devicepackagetransport stabilitystandards comparative analysis
国家科技期刊平台
NSTL
万方数据
维普
