眼科光学相干断层扫描仪关键性指标及标准化检测中质量控制研究  

Study on the QC of key indicators and standardized detection of ophthalmic OCT

作　　者：胡帆 杨赛 王冬梅 周强 孙小莉 吴健[3] HU Fan;YANG Sai;WANG Dong-mei(Henan Institute of Medical Device Inspections,Zhengzhou 450000,China)

机构地区：[1]河南省医疗器械检验所,河南郑州450003 [2]河南省计量科学研究院,河南郑州450000 [3]郑州大学公共卫生学院,河南郑州450001

出　　处：《中国医学装备》2021年第9期24-28,共5页China Medical Equipment

基　　金：国家重点研发计划(2018YFC0114501)“数字诊疗装备研发”。

摘　　要：目的:探讨眼科光学相干断层扫描(OCT)设备质量控制的关键性指标及标准化检测方法。方法:采用一种定制的检测装置分别检测OCT设备深度测量的精度、横向分辨率和纵向分辨率(轴向分辨率)、视场角、眼底图像和OCT图像的匹配(位置的一致性)等指标。结果:OCT设备深度测量的精度为0.995 mm,OCT扫描视场角为19°,眼底预览视场角为45°,横向分辨率为16.7μm,纵向分辨率为4.7μm,眼底图像和OCT图像的匹配度在100μm以内,其结果均符合国际标准化组织ISO16971-2015标准的要求。结论:研究探索的一套实际操作性强且可以普遍适用的检验装置及检测方法,能够为第三方检测机构在眼科OCT设备检验检测方面提供参考,并可为制造商的生产研发环节提供指导,为临床使用机构对在用眼科OCT设备的日常质量控制提供借鉴。Objective:To explore the key indicators and standardized detection methods of the quality control(QC)of ophthalmic optical coherence tomography(OCT)equipment.Methods:A customized detection device was used to detect the precision of depth measurement,transverse resolution and longitudinal resolution(axial resolution),field angle,matched-degree of the eye fundus image and OCT image(the uniformity of position),etc.Results:The precision of depth measurement of OCT equipment was 0.995mm,and field angle of OCT scan was 19°,and preview field angle of fundus was 45°,and transverse resolution was 16.7μm,and longitudinal resolution was 4.7μm,and the matcheddegree of eye fundus image and OCT image was within 100μm.All of these results could meet the requirement of the standards of International Standardization Organization(ISO 16971-2015).Conclusion:This paper researched and explored a set of inspection devices and detection method with highly actual operability and universally application,which can provide reference for the third-party inspection institutions in the aspects of inspection and detection of ophthalmic OCT equipment,and can provide guidance for the links of production,research and development of manufacturers,and can provide reference for the clinical institutions in the routine QC of ophthalmic OCT equipment.

关 键 词：眼科光学相干断层扫描(OCT) 横向分辨率 纵向分辨率 检验检测 质量控制 

分 类 号：R318.6[医药卫生—生物医学工程]