IEC 62359-2017 PDF

Full title and description

Ultrasonics — Field characterization — Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359:2010 with Amendment 1 published 2017). This 2017 publication is an amendment that updates test methods and calculation procedures used to determine exposure indices (thermal index, mechanical index) and related field-characterization parameters for medical diagnostic ultrasound.

Abstract

This document (Amendment 1 to IEC 62359) provides revisions and clarifications to field-characterization test methods for medical diagnostic ultrasonic fields, with particular emphasis on the determination and calculation of thermal and mechanical indices and related exposure parameters. It supplements the base IEC 62359 text by updating procedures for hydrophone measurements, parameter definitions and the computation algorithms used to estimate temperature-rise–related and non-thermal (mechanical) exposure metrics in tissue-equivalent models.

General information

• Status: Published.
• Publication date: 29 September 2017 (IEC publication date for Amendment 1 / consolidated 2017 edition).
• Publisher: International Electrotechnical Commission (IEC).
• ICS / categories: 17.140.50 (Electroacoustics / Ultrasonics).
• Edition / version: IEC 62359:2010 + Amendment 1 (Edition 2.0; consolidated 2017 edition commonly referenced as Edition 2.1).
• Number of pages: Amendment document: 28 pages (amendment pamphlet); consolidated and national/adopted versions (full standard + amendments) may be longer in adopted translations (for example national EN/DIN publications show longer page counts).

Scope

IEC 62359 (with the 2017 amendment) specifies test methods for characterization of diagnostic ultrasonic fields relevant to medical imaging. The scope covers: definitions of thermal and mechanical indices, procedures for hydrophone and field measurements, methods to calculate exposure-related parameters such as thermal index estimates and mechanical index, and guidance on use of tissue-equivalent modelling and acoustic intensity descriptors for diagnostic ultrasound equipment testing. It is intended to support consistent evaluation of potential thermal and non‑thermal bioeffects from diagnostic ultrasonic fields.

Key topics and requirements

• Definitions and formalization of thermal index (TI) and mechanical index (MI) used for diagnostic ultrasound safety labeling.
• Measurement techniques for ultrasonic field characterization, including hydrophone measurement practices and instrumentation considerations.
• Calculation methods and algorithms to estimate temperature-rise–related parameters in theoretical tissue-equivalent models.
• Procedures to determine mechanical (non-thermal) exposure parameters and to assess peak rarefactional pressure and related metrics.
• Guidance on reporting measured and computed exposure values for manufacturers, test laboratories and regulatory submissions.

Typical use and users

Primary users are medical device manufacturers (diagnostic ultrasound systems and transducer manufacturers), acoustical test laboratories, regulatory reviewers and conformity assessment bodies. The standard is used when characterizing the acoustic output of diagnostic ultrasound devices, preparing regulatory submissions, performing product safety assessments, and developing test protocols for system performance and labeling. The standard is also referenced by regulatory authorities and recognition lists for medical imaging device evaluation.

Related standards

IEC 62359 is related to other IEC standards and guidance for ultrasonic field measurement and reporting, including standards on hydrophone calibration and measurement (for example IEC 62127 series), related output and reporting standards (such as IEC 61157 / IEC 61161 family) and national/adopted EN versions that consolidate the base standard with amendments. Users should consult the referenced measurement and reporting standards for complete test chains.

Keywords

ultrasonics, field characterization, thermal index, mechanical index, diagnostic ultrasound, hydrophone measurement, acoustic intensity, medical ultrasound safety, IEC 62359, exposure assessment

FAQ

Q: What is this standard?

A: IEC 62359 (with Amendment 1 published in 2017) is an IEC international standard that defines field-characterization test methods and calculation procedures to determine thermal and mechanical indices and related exposure parameters for medical diagnostic ultrasonic fields.

Q: What does it cover?

A: It covers measurement techniques (including hydrophone methods), definitions and computation methods for thermal and mechanical indices, modelling approaches to estimate temperature rise in tissue-equivalent media, reporting conventions for acoustic exposure metrics, and related test procedures used in evaluation of diagnostic ultrasound devices.

Q: Who typically uses it?

A: Manufacturers of diagnostic ultrasound equipment, acoustic testing laboratories, conformity assessment bodies, and regulatory reviewers use this standard for device characterization, safety labeling, and regulatory submissions.

Q: Is it current or superseded?

A: The 2017 amendment (IEC 62359:2010/AMD1:2017, Edition 2.0 / consolidated 2017 edition) is a published amendment to the 2010 edition. Users should check the IEC catalogue or national adoption bodies for any later revisions or new edition projects; national/adopted consolidated publications (EN/DIN) incorporating the amendment may have different publication dates and pagination.

Q: Is it part of a series?

A: IEC 62359 is part of the set of IEC documents addressing ultrasonic measurement, metrology and reporting. It is closely linked with the IEC 62127 series (hydrophones) and other IEC publications that specify output measurement, reporting and safety-related metrics for medical ultrasound.

Q: What are the key keywords?

A: Thermal index, mechanical index, ultrasonic field characterization, hydrophone, acoustic intensity, diagnostic ultrasound safety, exposure assessment, IEC 62359.