中国医疗设备2024，Vol.39Issue(3)：58-62,5.DOI:10.3969/j.issn.1674-1633.2024.03.010
内窥镜设备安全性评价在新旧标准中的差异要点解读
Key Points of Difference Between Old and New Standards in the Safety Evaluation of Endoscope Equipment
摘要
Abstract
Objective To analyze the differences between the old and new standards in the safety evaluation of endoscope equipment,so as to promote its quality control.Methods Based on the working principle,structural features and main functions of endoscope equipment,the key points of difference in standards were summarized from both general and specific electrical safety standards.Some rational suggestions were put forward for the design and development of endoscope equipment.Results The main differences in safety evaluation of endoscope equipment between old and new standards were reflected in aspects such as basic safety,over-temperature protection,fire enclosure,cleaning,disinfection,sterilization,applied part,radiation safety,and the risk of interconnect with high-frequency equipment.Conclusion By analyzing the key points of the difference between the old and new standards in the safety evaluation of endoscope equipment,certain ideas are provided for the design and development of such products,and a reference is provided for the improvement of product quality evaluation system.关键词
内窥镜设备/安全性/评价/标准差异Key words
endoscopic equipment/safety/evaluation/difference in standards分类
医药卫生引用本文复制引用
蒋硕,万敏,李庆雨,裴晓娟,张在爱,冯乐菲,陈一依,张克..内窥镜设备安全性评价在新旧标准中的差异要点解读[J].中国医疗设备,2024,39(3):58-62,5.基金项目
山东省重点研发计划(重大科技创新工程)项目(2022CXGC010502) （重大科技创新工程）
山东省医疗器械和药品包装检验研究院内部科研课题(NB202208). （NB202208）
