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医用显示器性能稳定性研究及监管建议

Research on Performance Stability of Medical Display Devices and Regulatory Suggestions
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摘要 医用显示器作为医学影像诊断的关键终端设备,其性能稳定性直接影响临床诊断准确性。文章分析了影响医用显示器性能稳定性的关键指标,包括亮度、灰阶一致性等参数的变化规律,并研究了长期使用可靠性和系统稳定性对诊断效果的影响。同时,探讨了医用显示器性能稳定性的评估方法。结合国内外监管要求,提出了完善标准体系、加强全生命周期监管、提升行业认知等三条建议,旨在提高医用显示器的临床使用安全性和诊断准确性。 Medical displays are key terminal devices for medical imaging diagnosis,and their performance stability directly affects the accuracy and reliability of clinical diagnosis.This article systematically analyzes the key indicators that affect the performance stability of medical displays,including the variation patterns of parameters such as brightness and grayscale consistency,and explores the impact of long-term reliability and system stability on equipment performance.Meanwhile,the evaluation method for the stability of medical display performance was studied.Based on the current regulatory situation at home and abroad,three suggestions have been proposed to improve the standard system,strengthen full lifecycle supervision,and enhance industry awareness,in order to improve the clinical safety and diagnostic accuracy of medical displays.
作者 孟昭阳 孙智勇 马跃 MENG Zhao-yang;SUN Zhi-yong;MA Yue(Liaoning Inspection,Examination&Certification Centre,Liaoning Shenyang 110171)
出处 《中国医疗器械信息》 2025年第19期43-45,共3页 China Medical Device Information
基金 辽宁省自然科学基金联合基金(面上资助计划项目)(项目名称:医用显示器影像质量评价方法研究及监管建议,项目编号:2023-MSLH-098)。
关键词 医用显示器 性能稳定性 医用显示器监管建议 medical display performance stability regulatory recommendations for medical displays
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