Phantoms are physical models designed to mimic medical tissues and structures in medical imaging. They are used in medical research, quality assurance, and training. Despite their increasing application and widespread use, standardized frameworks for the verification and validation of phantoms remain insufficiently established, primarily due to the interdisciplinary challenges involved. This paper addresses this gap by identifying and categorizing essential validation aspects for medical imaging phantoms, derived from an extensive literature review. Building upon these categories—application validity, physiological validity, anatomical validity, user validity, economic validity, and concurrent validity—a structured validation matrix is proposed to guide users through a comprehensive interdisciplinary evaluation process. The matrix incorporates both objective measurements, such as imaging performance benchmarks and quantitative anatomical comparisons (e.g., Hounsfield Values, Dice coefficients, respectively), and subjective assessments from expert and user feedback. Emphasis is placed on aligning validation procedures with the specific purpose and intended use of each phantom, ensuring reproducibility through rigorous documentation of test conditions and outcomes. By integrating multidisciplinary criteria into a systematic validation framework, this work aims to enhance the reliability and usability of phantoms, providing a methodological tool embedded in the design process, which supports their development and application in advancing medical imaging technologies.
Wegner et al. (Thu,) studied this question.