IEC TS 62791:2015 PDF

Overview

IEC TS 62791:2015 provides a standardized test method for quantifying the imaging performance of real‑time, gray‑scale (B‑mode) medical ultrasound scanners using low‑echo sphere phantoms. The technical specification is applicable to a broad range of transducer types operating in the 2 MHz to 15 MHz frequency range. It defines terms, phantom geometries, data‑acquisition procedures and automated analysis steps to produce reproducible measures of sphere detectability and image quality.

Key topics and requirements

• Scope and applicability: Performance testing of pulse‑echo B‑mode scanners with transducers from 2 MHz to 15 MHz.
• Phantom design: Guidance for tissue‑mimicking (TM) phantoms containing a spatially random distribution of low‑echo spheres; separate geometry recommendations for 2–7 MHz and 7–15 MHz transducers (annex examples include 4 mm, 3.2 mm and 2 mm sphere sets).
• Imaging conditions: Environmental and general test conditions are specified to ensure repeatability.
• Data acquisition and storage: Procedures for acquiring multiple image frames, storing digitized images, and handling scanner‑native or archived image files.
• Automated analysis: Computation of mean pixel values (MPVs), identification of sphere centres and calculation of the LSNR‑value (a standardized detectability metric defined in the TS) as a function of depth; includes estimation of standard errors and reproducibility checks.
• Special cases: Advice on total internal reflection surfaces, 3‑D probe considerations (2‑D imaging mode, 3‑D reconstructions, mechanically driven probes) and recommendations for sufficient image counts to assure reproducibility.

Practical applications and users

Who benefits from IEC TS 62791:2015:

• Ultrasound manufacturers - for design validation, performance benchmarking and acceptance testing across transducer types.
• Clinical engineers and medical physicists - for routine quality assurance (QA), acceptance testing and longitudinal performance monitoring of ultrasound systems.
• Independent test laboratories and regulators - to produce reproducible, comparable performance reports for devices under test.
• R&D teams and procurement groups - for objective comparison of gray‑scale imaging performance when evaluating systems or new transducer designs.

Typical uses:

• Acceptance testing of new scanners
• Periodic QA and regression testing after software/hardware changes
• Comparative studies between scanners or transducer models
• Development and validation of image‑processing features that affect gray‑scale detectability

Related standards

See the IEC catalogue and other IEC publications on medical ultrasound and tissue‑mimicking phantoms for complementary guidance. IEC TS 62791 references normative documents and provides cross‑links to broader IEC resources (webstore.iec.ch, Electropedia) for up‑to‑date standards and terminology.