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
于晓慧 1陈方 2李文丽 1邵国俊3
作者信息
- 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;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
- 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;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
- 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;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
- 折叠
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.
Abstract
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Key words
medical electrical equipment/GB/T 14710-2009/simulated transportation test/environmental hazards/road transportation test引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据