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Periodic quality assurance of diagnostic ultrasound systems is essential for maintaining diagnostic accuracy and patient safety. IEC TS 62558:2011 provides a standardized approach for evaluating the void-detectability ratio (VDR) of 3D ultrasound imaging systems using a specially designed phantom containing cylindrical artificial cysts embedded in tissue-mimicking material (TMM).
IEC TS 62558 specifies a measurement method and phantom design for evaluating and periodically testing the 3D distributions of void-detectability ratio in real-time pulse-echo ultrasound scanners. The standard is applicable to ultrasound systems operating in the frequency range from 1 MHz to 15 MHz, covering most diagnostic imaging applications including abdominal, obstetrics, gynecology, and musculoskeletal imaging.
The phantom-based approach allows healthcare facilities and manufacturers to:
The standard specifies rigorous requirements for the TMM used in constructing the phantom. The material must closely match the acoustic properties of soft tissue to ensure clinically relevant measurements.
| Property | Specification | Tolerance | Measurement Method |
|---|---|---|---|
| Speed of sound | 1540 m/s | ±10 m/s | Time-of-flight method |
| Attenuation coefficient | 0.5 dB/(cm·MHz) | ±0.05 dB/(cm·MHz) | Insertion loss method |
| Backscatter coefficient | Mimics soft tissue | Per Annex specification | Reference phantom method |
| Density | 1.04 g/cm³ | ±0.02 g/cm³ | Gravimetric |
| Non-linearity parameter B/A | ~6.9 | ±0.5 | Finite amplitude method |
The phantom contains cylindrical anechoic cavities (voids) of various diameters arranged in a 3D matrix. Each void slice contains holes of different diameters, enabling evaluation across multiple ultrasound frequencies. The void diameters range from 1 mm to 8 mm, simulating cysts of various sizes in clinical practice.
The VDR calculation involves voxel-level analysis of the acquired 3D ultrasound data compared to known void locations in the phantom. The standard defines a systematic process:
The standard’s informative Annexes provide example construction procedures, test results, and system characterization data that help phantom manufacturers and test laboratories implement consistent evaluation protocols.
The TMM formulation specified in the standard is designed for long-term stability. Properly constructed and stored phantoms typically maintain their acoustic properties for 2-3 years. The enclosure must be hermetically sealed to prevent dehydration and contamination. Routine stability checks involve periodic measurement of reference voids and comparison with baseline data established during phantom qualification.
Q1: How often should VDR testing be performed using the IEC TS 62558 phantom?
A: For clinical systems, quarterly testing is recommended as part of a routine quality assurance program. After major repairs or software upgrades, additional testing should be performed to establish new baseline performance data.
Q2: What is the typical lifespan of a TMM phantom?
A: With proper storage and handling, TMM phantoms typically last 2-3 years. The TMM should be stored in a controlled environment (18-25°C) away from direct sunlight. Signs of dehydration (surface cracking, altered echogenicity) indicate end of useful life.
Q3: Can the same phantom be used for 2D and 3D ultrasound quality assurance?
A: Yes, while designed specifically for 3D VDR evaluation, the phantom can also be used for conventional 2D quality assurance tests including B-mode uniformity, spatial resolution, and anechoic cyst detection.
Q4: How is the VDR affected by ultrasound frequency?
A: Higher frequencies generally provide better spatial resolution and thus higher VDR for small cysts, but suffer from reduced penetration depth. The standard’s phantom includes voids of various diameters to test system performance across the clinically relevant frequency range.