电子内窥镜产品国内外畸变性能评价方法的探讨
Discussion on the evaluation methods of distortion properties of electronic endoscope products at domestic and abroad
仲志真 1唐伟 2宓云軿1
作者信息
- 1. 上海市医疗器械化妆品审评核查中心 上海 200020
- 2. 上海安清医疗器械有限公司 上海 201201
- 折叠
摘要
目的:比较中国、欧盟和美国在电子内窥镜图像畸变的评价方法上存在的差异,为制定更为科学合理的评价方法提供参考.方法:详述中国、欧盟和美国注册中畸变评价的 3 种标准方法,分析评价这 3 种方法的异同,针对每种方法的科学合理性及可操作性进行深入探讨.结果:通过对比分析,3 种方法各自存在优势和不足.结论:中国的畸变评价法中球面视场更贴近实际,利于实现设备的自动化测试和计算.
Abstract
Objective:To compare the differences in the evaluation methods of image distortion of electronic endoscopes in China,the European Union(EU)and the United States(US),and to provide reference for the development of more scientific and reasonable evaluation methods.Methods:Three standard methods of distortion evaluation in China,EU and US were described in detail,their differences and similarities were analyzed and evaluated,and the scientific rationality and operability of each method were discussed in depth.Results:Through comparative analysis,each of them has its own advantages and shortcomings.Conclusion:Spherical field of view in China's distortion evaluation method is closer to reality,which is conducive to achieving automated testing and calculation of equipment.
关键词
内窥镜/图像质量/畸变/单色像差Key words
endoscope/image quality/distortion/monochromatic aberration引用本文复制引用
出版年
2024
NETL
NSTL
万方数据