Research on the Standardized Testing Process and Methods of the Graphics Measurement Function of Medical Device Software

With the widespread application of medical device software in clinical diagnosis and treatment, the accuracy and reliability of graphical measurement functions, as a core module, 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 graphical measurement functions in medical device software, this study systematically analyzes the common characteristics of these measurement functions. A black-box testing methodology is proposed, establishing a standardized testing framework based on digital phantoms. This framework 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 graphical measurement functions in medical device software. This advancement contributes to enhancing the clinical safety of medical software and ensuring regulatory consistency.