Overview
IEC 63412-1:2024 is the first part in the IEC 63412 series, providing standardized specifications for the user interface of medical ultrasound shear-wave elastography systems. Prepared by IEC Technical Committee 87 (Ultrasonics), this international standard outlines the essential quantities and parameters that must be presented to users, particularly within image headers. The primary objective is to ensure clarity, accuracy, and consistency for operators, facilitating reliable liver and other organ assessments via non-invasive imaging.
Shear-wave elastography is an advanced medical imaging technique that measures the speed of shear waves in tissue, offering quantitative information about tissue stiffness - a valuable indicator for diagnosing various diseases, especially liver fibrosis. IEC 63412-1:2024 establishes a framework for presenting these measurements and related derived parameters, supporting improved communication, comparability, and reproducibility across different systems and clinical environments.
Key Topics
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Essential User Interface Parameters:
The standard defines the mandatory parameters for display, such as shear-wave speed (expressed in meters per second), as well as optional derived values like shear modulus and Young’s modulus. All presented quantities must be labeled with both their name/abbreviation and units.
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Documentation Requirements:
System documentation-including user manuals-must provide detailed explanations about all displayed values, underlying assumptions (e.g., tissue density, linearity, isotropy, incompressibility), and the formulas used to derive moduli from shear-wave speed.
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Shear-Wave Excitation and Propagation:
Manufacturers must specify excitation frequency and duration, as these impact measurement accuracy. The assumed direction of shear-wave propagation and tissue displacement, relative to transducer orientation, must also be clearly described.
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Dispersion Effects and Data Processing Transparency:
User documentation should disclose if shear-wave speed estimates are based on particle-displacement or particle-velocity data, as well as any filtering applied to the data. This transparency is vital for understanding potential biases in frequency-dependent shear-wave speed estimation, which can affect clinical interpretation.
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Standardized Colour Mapping:
For systems producing two-dimensional shear-wave speed images, IEC 63412-1 mandates the availability of a standardized, perceptually uniform colour map. This improves visualization consistency across different devices, minimizing the risk of misinterpretation due to colour display variabilities.
Applications
IEC 63412-1:2024 applies to all medical-diagnostic ultrasound systems utilizing shear-wave elastography for tissue characterization. While the primary clinical focus is liver assessment, the specifications are also relevant for imaging other organs such as the breast, thyroid, prostate, kidney, and muscle. Key applications include:
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Clinical Diagnosis:
Non-invasive detection and monitoring of liver fibrosis, tumor stiffness, and muscular disorders, leveraging standardized user interfaces and reporting for enhanced diagnostic confidence.
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System Comparison and Quality Assurance:
Enabling fair comparison of quantitative elastography data across devices, sites, and over time, which supports research, clinical trials, and regulatory compliance.
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Operator Training and Safety:
Clear interface prompts and documentation improve user comprehension and support safe operation, including the avoidance of excessive exposure to intense push pulses.
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Data Consistency and Interoperability:
Standardized value presentation and colour mapping facilitate data sharing, integration with electronic health records, and multi-center studies.
Related Standards
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IEC 63412-2 (planned):
Will specify requirements for test objects (phantoms) used in device calibration and performance validation.
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IEC 63412-3 (planned):
Will define test procedures for performance and constancy assessment of shear-wave elastography systems.
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ISO 5577:
Provides general terminology for ultrasonics, referenced for key definitions in this standard.
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IEC Electropedia & ISO Online Browsing Platform:
Authoritative sources for standardized terms referenced throughout the document.
By adhering to IEC 63412-1:2024, manufacturers, clinicians, and researchers can ensure that shear-wave elastography systems deliver clear, standardized output, supporting improved patient outcomes and reliable clinical decision-making.