Key Points of Difference Between Old and New Standards in the Safety Evaluation
of Endoscope Equipment
JIANG Shuo1,2, WAN Min1,2, LI Qingyu1,2, PEI Xiaojuan1,2, ZHANG Zaiai1,2, FENG Lefei1,2, CHEN Yiyi1,2, ZHANG Ke1,2
1. Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection, Jinan Shandong 250101, China; 2. NMPA Key
Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices, Jinan Shandong 250101, China
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, overtemperature
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.
蒋硕1,2，万敏1,2，李庆雨1,2，裴晓娟1,2，张在爱1,2，冯乐菲1,2，陈一依1,2，张克1,2. 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.
JIANG Shuo1,2, WAN Min1,2, LI Qingyu1,2, PEI Xiaojuan1,2, ZHANG Zaiai1,2, FENG Lefei1,2, CHEN Yiyi1,2, ZHANG Ke1,2. Key Points of Difference Between Old and New Standards in the Safety Evaluation
of Endoscope Equipment. China Medical Devices, 2024, 39(3): 58-62.
