医用电气设备模拟运输试验标准探讨  

Exploration of the Standard for Simulation Transport Tests of Medical Electrical Equipment

作　　者：于晓慧 陈方 李文丽 邵国俊 YU Xiaohui;CHEN Fang;LI Wenli;SHAO Guojun(Pharmaceutical Packaging Quality Evaluation Center,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250101,China;Scientific Research and Standardization Innovation Center,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250101,China;Sampling Inspection and Reception Office,Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan Shandong 250101,China;NMPA Key Laboratory of Quality Control for Pharmaceutical Packaging,Jinan Shandong 250101,China)

机构地区：[1]山东省医疗器械和药品包装检验研究院药品包装质量评价中心,山东济南250101 [2]山东省医疗器械和药品包装检验研究院科研标准创新中心,山东济南250101 [3]山东省医疗器械和药品包装检验研究院抽验受理办公室,山东济南250101 [4]国家药品监督管理局药品包装材料质量控制重点实验室,山东济南250101

出　　处：《中国医疗设备》2024年第8期120-125,共6页China Medical Devices

摘　　要：目的为我国医用电气设备的运输稳定性验证提供更好的评价方式及思路。方法梳理医用电气设备的流通特点及我国标准GB/T 14710-2009中运输试验存在的问题,分析国内外模拟运输试验主要参考标准的内容,对比探讨GB/T 14710-2009中规定的公路运输与其他运输标准的技术性差异。结果医用电气设备的模拟运输试验不仅限于GB/T 14710-2009中规定的三级公路运输,还包括搬运时的跌落、堆码中产生的挤压、多种路况及不同运输工具带来的振动等其他环节。结论应综合考察产品本身及流通周期中可能经历的各类潜在环境危害,结合实际确定运输试验具体内容。Objective To provide a better evaluation method and approach for verifying the transport stability of medical electrical equipment in China.Methods The circulation characteristics of medical electrical equipment and the problems existing in the standard GB/T 14710-2009 regarding transport tests was reviewed,and the contents of the main reference standards for simulated transportation tests at home and abroad were analyzed,and the technical differences between road transport as stipulated in GB/T 14710-2009 and other transport standards were compared.Results The simulated transport tests of medical electrical equipment were not limited to the third-class road transport specified in GB/T 14710-2009,but also included other aspects such as drops during handling,compression during stacking,vibrations from various road conditions and different modes of transportation.Conclusion It is essential to comprehensively assess the product itself and various potential environmental hazards that may be encountered during the circulation cycle,and determine the specific content of the transport test based on practical considerations.

关 键 词：医用电气设备 GB/T 14710-2009 模拟运输试验 环境危害 公路运输试验 

分 类 号：R197.39[医药卫生—卫生事业管理]