Feasibility of Reference Material Certification for Speed of Sound and Attenuation Coefficient Based on Standard Tissue-Mimicking Material

Abstract

Speed of sound and attenuation are essential for characterizing reference materials such as biological tissue-mimicking materials (TMMs) used in ultrasonic applications. There are many publications on the manufacture of TMMs and the measurement of their properties. However, no studies in the literature have applied the metrological approach of International Organization for Standardization (ISO) Guide 35 to certify biological ultrasound TMMs as candidates for reference materials (RMs). The work described here was aimed at studying the process for manufacturing fat, muscle and aorta artery TMMs, including the study of the homogeneity, stability, trend and characterization of TMMs. The properties of interest were the speed of sound (SoS) and attenuation coefficient (AttC) at 7.5 MHz, with target expanded uncertainty of 40 m/s and 0.3 dB/cm, respectively. The short-term stability study was 2 mo at 4°C and 40°C (simulating possible transportation conditions). The long-term stability study lasted an additional 4 mo with the TMM at 22°C (simulating possible storage conditions). Homogeneity was evaluated before the stability study. Uncertainties associated with homogeneity, stability, characterization and trend were duly calculated. No trend was observed in this study, but the AttC spread widely during the stability test, substantially enlarging the final uncertainty. Therefore, this property could not be used to certify TMM candidates as RMs. However, the SoSs for most TMMs lay within the target uncertainty, disclosing viability to certify TMMs as RMs for this property. Assigned values for SoS were 1560 m/s for aorta TMM with an average expanded uncertainty for certificate validity of 12 mo (Ue;12=20 m/s), 1552 m/s for muscle TMM (Ue;12=20 m/s) and 1494 m/s for fat TMM (Ue;12=11 m/s). Thus, TMMs were proved suitable to be certified as RMs for SoS.