中国医疗设备2018，Vol.33Issue(3)：87-90,4.DOI:10.3969/j.issn.1674-1633.2018.03.022
输液泵/注射泵质量评价与分析
Quality Evaluation and Analysis for Infusion/Syringe Pumps
张克 1陈甜甜 1范书健 1刘铮1
作者信息
- 1. 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
- 折叠
摘要
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 problems of such products, recommendations will put forward to the manufacturers, and thus the overall quality of products will be improved to protect people's safety.关键词
输液泵/注射泵/国家医疗器械抽验/质量评价与分析Key words
infusion pumps/syringe pumps/national medical devices sampling inspection/quality evaluation and analysis分类
医药卫生引用本文复制引用
张克,陈甜甜,范书健,刘铮..输液泵/注射泵质量评价与分析[J].中国医疗设备,2018,33(3):87-90,4.
