Liver-specific phantom design for phsiological and pathological ultrasound imaging within the scope of ISO 17043 and ISO 13485

This study focuses on the development of a cost-effective and locally producible ultrasound phantom designed to simulate the physiological and pathological properties of the liver. Ultrasound technology plays a crucşal role in medical device calibration and user training due to its advantages, such as non-ionizing radiation, the ability to image soft tissues and real-time analysis capabilities. However, the high cost and limited customizability of commercial ultrasound phantoms often restrict their widespread application. To address this issue, a low-cost and locally producible alternative was developped using materials such as agar-agar, zinc chloride and silicone to effectively replicate the acoustic properties of biological tissues. Furthermore, vascular structures were simulated using aspiration catheters and a recirculation pump, enabling the dynamic visualization of blood flow. The phantom was optimized to mimic both healthy and pathological tissue characteristics. The design, production and validation processes adhered to ISO 17043 and ISO 13485 standards, ensuring compliance with international medical device quality and performance benchmarks. Experimental findings demonstarted the phantom's effectiveness in training and calibration applications, with high compatibility with ultrasound devices and realistic tissue simulation. This study highlights the potential of locally developed and customizable solutions in medical education and research, offering a sustainable alternative to expensive commercial products.