医疗器械包装运输测试标准应用对比分析

摘要：

本文以医疗器械包装运输性能测试应用为主旨，系统分析国内外医疗器械包装运输标准异同。文章比对分析国际运输安全协会、美国标准、我国国家标准以及医药行业标准的主要适用范围、测试项目差异，并以质量为50kg的医疗器械包装件为例，分析运输测试温湿度条件、低气压、振动、冲击、堆码试验参数等效性与差异性。分别对有源、无菌和涉及中美双报的医疗器械包装运输测试提出应重点关注的项目，为开展医疗器械全生命周期监管提供技术支持。

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.

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。

作者简介：刘姗姗，工程师，主要从事进出口商品检验研究。冯智劼，研究员，主要从事进出口商品检验研究。李学洋，高级工程师，主要从事进出口商品检验研究。张闯，工程师，主要从事进出口商品检验研究。李涛，通信作者，高级工程师，主要从事进出口商品检验及风险研究。