医疗卫生装备2018，Vol.39Issue(3)：76-78,3.DOI:10.7687/j.issn1003-8868.2018.03.076
输液泵/注射泵问题分析及监管对策
Problem analysis and supervision strategy 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,济南250101
- 折叠
摘要
Abstract
Objective To analyze the problems found during the sampling inspection of the infusion and syringe pumps. Methods The present situation of the supervision of medical devices was explored,and statistical analysis was executed on the sampling inspection results of medical devices in 2016 to evaluate completely their quality and application.Results The medical devices had problems in uneven quality,low rate of coverage of sampling inspection,unreferencing YY 0709—2009 Medical Electrical Equipment-Part 1-8:General Requirements for Safety-Collateral Stanalard:General Requirements,Tests and Guidance for Alarm Systems in Medical Eleatriail Equipment and Medical Electrical Systems when registering product standard and technical requirements,external labeling,instruction manual and packaging.The qualification rate for sampling inspection was kept at low level in the past few years.Conclusion The supervision strategy is put forward for medical devices to enhance their overall quality.关键词
输液泵/注射泵/国家医疗器械抽验/问题分析/监管对策Key words
infusion pump/syringe pump/national medical devices sampling inspection/problem analysis/supervision strategy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/注射泵问题分析及监管对策[J].医疗卫生装备,2018,39(3):76-78,3.
