IEC 61828:2020

IEC 61828:2020 Overview

IEC 61828:2020 is a comprehensive international standard developed by the International Electrotechnical Commission (IEC) that defines key terms and measurement methods for focusing ultrasonic transducers used in medical ultrasound applications. This standard addresses both focusing and nonfocusing transducers operating across the medical ultrasound frequency range of 0.5 MHz to 40 MHz, covering diagnostic and therapeutic applications. It is essential for system designers, researchers, and quality assurance professionals involved in characterizing ultrasonic fields emitted by transducers.

This edition supersedes the original 2001 version, incorporating extensive technical revisions, including new measurement techniques, updated definitions, and expanded annexes to support enhanced accuracy in transducer characterization.

Key Topics

• Definitions for Transmitted Fields
  The standard establishes precise terminology for describing transmitted ultrasound fields of focusing and nonfocusing transducers, linking theory, design, and measurement.

• Measurement Methods
  It prescribes detailed procedures using hydrophones to measure ultrasound fields in standard test media such as water, reflecting conditions similar to biological soft tissues and tissue-mimicking gels.

• Beam Axis Alignment
  IEC 61828:2020 specifies techniques for accurate alignment of hydrophones and transducers, critical for reliable beam characterization.

• Advanced Measurement Procedures
  The document outlines methods for various field characteristics including beamwidth, beam area, beam maximum, spatial impulse response, and numerical projection of focal parameters.

• New Technical Additions

  • Separate clauses for acoustic field measurement equipment and measurement procedures for clarity.
  • Incorporation of measurements involving time delays, array transducers, plane and steered waves, and high intensity therapeutic ultrasound (HITU) fields.
  • Expanded guidance on pulsed waves, focusing gains, minimum beamwidth estimation, and managing hydrophone limits to avoid nonlinearity.

• Supportive Informative Annexes
  These cover rationale for definitions, measurement uncertainties, positioning systems, planar hydrophone scanning for acoustic power, and precise water properties affecting measurement fidelity.

Applications

IEC 61828:2020 is fundamental for applications involving:

• Medical Ultrasound Device Development
  Facilitating consistent characterization and quality assessment of focusing and nonfocusing transducers used in diagnostic imaging and therapeutic procedures.

• Safety and Performance Evaluation
  Providing standardized parameters and measurement protocols essential for assessing the acoustic output, ensuring efficacy and patient safety.

• Research and Scientific Communication
  Offering a common terminology and methodology to support reproducible experimental setups and comparative studies in ultrasound technology.

• Calibration and Quality Control Laboratories
  Guiding hydrophone-based acoustic field measurements to maintain compliance with regulatory and industry standards.

Related Standards

IEC 61828:2020 aligns with and references other international standards relevant to ultrasonics and medical devices, including:

• IEC 60601 Series – Safety and performance standards for medical electrical equipment.
• IEC 61689 – Standard on ultrasonic physiotherapy transducers.
• ISO/TR 11137 – Sterilization of health care products using radiation, relevant for device safety.
• IEC 62127 Series – Ultrasonics hydrophone measurement methods.

This integration ensures interoperability and harmonized terminology across medical ultrasound equipments' evaluation standards.

Keywords: IEC 61828, ultrasonic transducers, focusing transducers, medical ultrasound, acoustic field measurement, hydrophone, beam axis alignment, ultrasound beam characterization, diagnostic ultrasound, therapeutic ultrasound, ultrasonic safety standards, ultrasonic measurement methods.