Treffer: [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software].
Local Abstract: [Publisher, Chinese] 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。.
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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.