输液泵注射泵质量评价与分析.PDFVIP

MEDICAL ENGINEERING TECHNOLOGY 医学工程技术 输液泵/注射泵质量评价与分析 张克，陈甜甜，范书健，刘铮 山东省医疗器械产品质量检验中心医用电器检验室，山东济南 250101 [摘 要] 目的 为生产企业提高输液泵/注射泵产品质量，加强产品质量管理，提供参考。方法 对输液泵/注射泵产品2016年国 家医疗器械抽验结果进行统计、分析及探讨，重点分析不合格项目及原因，探索研究潜在质量风险点。结果 法定标准检验 有6个检验项目出现不合格产品，“供电电源的中断”在不合格产品中的出现率最高，达到75.0% 。探索研究发现注册产品 标准/产品技术要求未引用YY0709-2009情况较多，“丸剂量和阻塞的防止”整体质量不高，存在安全隐患。结论 针对该类 产品现有问题，向生产企业提出建议，进而提高产品质量水平，保障人民群众用械安全。 [关键词] 输液泵；注射泵；国家医疗器械抽验；质量评价与分析 Quality Evaluation and Analysis for Infusion/Syringe Pumps ZHANG Ke, CHEN Tiantian, FAN Shujian, LIU Zheng Department of Medical Electrical Equipment Inspection, Shandong Quality Inspection Center for Medical Devices, Jinan Shangdong 250101, China Abstract: Objective To provide a reference for improving the quality of infusion/ syringe pumps, and strengthen the management for the production enterprises. Methods Statistics, analysis and discussion was performed on the current supervision status and national medical devices sampling inspection results in 2016, especially these non-compliance items and reasons, and the potential quality risk points were explored and researched. Results There were 6 test items appeared to be substandard products in the statutory “ ” standards test, and the interruption of the power supply was the highest incidence of substandard products, reaching at 75.0%. The results of the exploration and research indicated that many of registered product standards/product technical requirements were not “ ” quoted YY0709-2009, and the overall quality of protection against bolus volumes and occlusion was not high enough, there were potential safety issues. Conclusion In view of the existing