[Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]

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.