Overview
IEC 61391-2:2010 - Ultrasonics - Pulse-echo scanners - Part 2 specifies standardized test methods and terms for measuring two core performance metrics of real‑time ultrasound B‑mode (pulse‑echo) scanners:
- Maximum depth of penetration (system sensitivity)
- Local dynamic range (ability to display low‑level echoes near strong echoes)
The standard applies to pulse‑echo B‑mode scanners and the broad range of transducers they use (mechanical probes, phased arrays, linear/curved arrays, 2D and 3D probes) operating in the 1 MHz to 15 MHz frequency band. It covers both fundamental and harmonic modes that fall within this frequency range (harmonic modes above 15 MHz are excluded).
Key Topics and Requirements
- Scope and definitions for B‑mode scanners and scan geometry, aligned with IEC 61391‑1 terminology.
- Measurement methodology for:
- Determining maximum depth of penetration using dedicated penetration phantoms (Annex A).
- Measuring local dynamic range using acoustic‑signal injection and acoustically‑coupled burst techniques, and using phantoms with inclusions or reflectors (Annex B, figures provided).
- Test objects (phantoms): descriptions of suitable phantom types and guidance on reporting phantom specifics with test results.
- Data access: procedures assume access to digitized image data; where not available, frame‑grabber capture is acceptable.
- Environmental and equipment conditions, instrumentation required, and recommended analysis practices for reliable, reproducible measurements.
- Frequency recommendations: designed for 1–15 MHz operation; phantom manufacturers are encouraged to extend phantom specifications above 15 MHz where appropriate.
Practical Applications - Who Uses This Standard
- Ultrasound equipment manufacturers - to specify and validate scanner performance for product datasheets and design verification.
- Test laboratories and QA/acceptance teams - for factory acceptance, routine performance checks, and maintenance verification.
- Clinical engineers and hospital biomedical departments - to assess whether imaging systems meet operational sensitivity and contrast‑range needs for clinical tasks.
- Regulatory and procurement specialists - to compare devices objectively and support compliance evidence.
- R&D teams - to benchmark front‑end/back‑end design choices (transducers, beamformers, image processing).
Benefits include standardized, repeatable measurements that enable meaningful comparisons of maximum penetration depth and local dynamic range across different makes and models.
Related Standards (if applicable)
- IEC 61391‑1:2006 - Techniques for calibrating spatial measurement systems and measurement of system point‑spread function.
- IEC 62127‑1:2007 - Hydrophones: measurement and characterization of medical ultrasonic fields (up to 40 MHz).
- IEC 60601‑1 - General requirements for basic safety and essential performance of medical electrical equipment.
Keywords: IEC 61391-2, ultrasonics, pulse-echo scanners, maximum depth of penetration, local dynamic range, B‑mode, transducers, phantoms, ultrasound test methods, 1–15 MHz.