IEC TR 61390:2022 PDF

Overview

IEC TR 61390:2022 - Ultrasonics - Real-time pulse-echo systems - Test procedures to determine performance specifications - is a technical report from the IEC that defines representative test procedures for measuring the performance of complete real‑time medical ultrasonic imaging equipment operating in the 0.5 MHz to 23 MHz band. The report covers pulse‑echo scanners (mechanical sector, electronic phased‑array sector, linear array, curved array, water‑bath scanners, plane‑wave/fast imaging scanners and hybrid arrangements) and specifies methods based on:

• Sonograms from tissue‑mimicking objects (phantoms)
• Sonograms from artificial low‑ or high‑reflective targets
• Measured parameters of the transmitted ultrasound field

Note: IEC TR 61390:2022 does not specify methods for measuring electrical parameters of scanner electronics. This edition updates the 1996 first edition and adds new phantom designs, additional transducer types and analysis methods (Annex B).

Key topics and technical requirements

The report organizes practical test procedures and equipment guidance. Major topics include:

• Recommended equipment (Clause 6.1): hydrophones, oscilloscopes/transient recorders, spectrum analyzers, pulse generators, degassed water tanks, target holders/positioning systems, tissue‑mimicking phantoms, and evaluation software
• Test settings and display/sensitivity optimizations (Clause 6.2)
• Measured performance parameters (Clause 6.3), including:
  • Acoustic working‑frequency bandwidth
  • Axial, lateral and elevational resolution
  • Contrast‑detail resolution and display sonic contrast
  • Detectability of non‑ or minimally‑scattering regions
  • Dead zone, proximal/distal working limits and depth of penetration
  • Slice thickness, beam shape and uniformity degradation
  • Displayed dynamic range, M‑mode calibration and measurement accuracy
• Phantom descriptions and tissue‑mimicking materials (Annex A)
• Analysis methods for complex phantoms (Annex B), including automated segmentation and beam profile analysis

Practical applications and who uses this standard

IEC TR 61390:2022 is a practical reference for:

• Ultrasound scanner manufacturers - for design verification, performance claims and R&D
• Independent test laboratories and conformity assessment bodies - for standardized performance testing
• Clinical/biomedical engineering teams - for acceptance testing and periodic quality assurance
• Regulators and procurement specialists - to interpret and compare imaging performance specifications
• Research groups developing novel transducers or imaging modes (plane‑wave/fast imaging)

Use cases include verifying resolution and contrast performance with tissue‑mimicking phantoms, mapping beam profiles, quantifying depth of penetration, and validating display accuracy.

Related standards

IEC TR 61390:2022 complements other IEC and medical‑device standards covering ultrasonic equipment safety, electrical performance and clinical requirements. Consult the IEC standards catalogue for related ultrasonics and medical electrical equipment publications.

Keywords: IEC TR 61390:2022, ultrasonics, real‑time pulse‑echo systems, medical ultrasonic imaging, test procedures, performance specifications, tissue‑mimicking phantoms, hydrophone, resolution, contrast, slice thickness.