Page 5 - 《中国医疗器械杂志》2025年第6期

Chinese Journal of Medical Instrumentation 2025年 第49卷 第6期

研 究 与 论 著

文章编号：1671-7104(2025)06-0591-06

医疗器械软件图形学测量功能的标准化

测试过程与方法的研究

【作 者】 刘重生 ，李银洁 1,2
1,2
1 上海市医疗器械检验研究院，上海市，201318
2 国家药品监督管理局医用电气设备重点实验室, 上海市, 201318
【摘 要】 医疗器械软件在临床诊疗中的应用越来越广泛。图形学测量功能作为医疗器械软件的核心模块，其准确性
与可靠性直接影响医疗决策质量。然而，当前国内外对图形学测量功能缺乏统一的标准化测试方法，导致
该方面存在验证方法不一致、测试流程不统一等问题。该研究针对医疗器械软件图形学测量功能的标准化
测试需求，系统分析测量功能的共性特征，采用黑盒测试方法，基于数字模体的标准化测试框架，构建了
涵盖功能适用性与准确性的测试指标体系，设计了数字模体的制备方法及具备可追溯性的验证流程。该研
究建立的标准化测试方法填补了该领域标准化测试方法的空白，为医疗器械软件图形学测量功能的注册审
评、质量验证提供了可量化的技术依据，有助于提升医疗器械软件的临床安全性与监管一致性。
【关 键 词】 医疗器械软件；图形学测量；功能准确性
【中图分类号】 R319; R45
【文献标志码】 A doi: 10.12455/j.issn.1671-7104.250301
Research on Standardized Testing Processes and Methods of Graphics
Measurement Functions of Medical Device Software

1,2
【 Authors 】 LIU Zhongsheng , LI Yinjie 1,2
1 Shanghai Institute of Medical Device Testing, Shanghai, 201318
2 NMPA Key Laboratory for Medical Electrical Equipment, Shanghai, 201318
【 Abstract 】 With the widespread application of medical device software in clinical diagnosis and treatment, the
accuracy and reliability of graphics measurement functions, which are core modules of medical device
software, directly impact the quality of medical decision-making. However, the current lack of
standardized testing methods both domestically and internationally has led to inconsistencies in
verification approaches and testing protocols. Addressing the standardized testing requirements for
graphics measurement functions in medical device software, this study systematically analyzes the
common characteristics of these measurement functions. Based on the black-box testing methodology
and a digital phantom-based standardized testing framework, it constructs a testing indicator system
encompassing functional applicability and accuracy, while designing preparation methods for digital
phantoms and traceability validation processes. The standardized testing method developed in this study
fills a critical gap in the standardization of testing methods for this domain. It provides quantifiable
technical criteria for the regulatory review and quality verification of graphics measurement functions in
medical device software. This advancement contributes to enhancing the clinical safety of medical
software and ensuring regulatory consistency.
【Key words】 medical device software, graphics measurement, functional accuracy

0 引言 疗诊断和治疗中发挥着越来越重要的作用。其中，
测量图形学参数的功能 [1-3] 作为医疗器械软件的重
随着医疗技术的不断进步，医疗器械软件在医 要组成部分，为医生提供了获取可量化的图形学数

据的手段，有助于提升医疗服务的质量和效率。
收稿日期：2025-05-06
作者简介：刘重生，E-mail: cmtc.lzs@foxmail.com 该功能在我国的《医疗器械软件注册审查指导

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