IEC 61846-2025 PDF

Full title and description

IEC 61846:2025 — Ultrasonics — Therapeutic focused short pressure pulse sources — Characteristics of fields. This international standard specifies parameters, measurement methods and field-characterization approaches for extracorporeally generated, focused short pressure-pulse therapy sources (originally developed for lithotripsy but broadened to cover other therapeutic applications using focused, non‑thermal short pressure pulses).

Abstract

IEC 61846:2025 updates the 1998 edition to reflect technical and clinical developments in focused short pressure‑pulse therapy devices. It defines measurable acoustic parameters (including revised −n dB and n MPa metrics), introduces new derived parameters (momentum, average positive acoustic pressure, cavitation induction index, pulse‑to‑pulse variability, total pressure pulse energy dose), and gives measurement requirements and hydrophone guidance for characterization and declaration of acoustic output of focused short pressure‑pulse therapeutic equipment. The document excludes percutaneous/laser lithotripsy, histotripsy and long‑duration ultrasound bursts.

General information

• Status: Published / Current (technical revision of the earlier edition).
• Publication date: 30 January 2025.
• Publisher: IEC (International Electrotechnical Commission), bilingual English/French release.
• ICS / categories: 11.040.50 (Medical radiology and ultrasonics).
• Edition / version: Edition 2.0 (2025).
• Number of pages: 80 pages (base IEC publication).

Key bibliographic and release details above are taken from the IEC publication record and national adoption entries.

Scope

Applies to therapy equipment that generates extracorporeally induced, focused short pressure pulses (focused mechanical-energy, non‑thermal pulses). The standard specifies parameters used for declaration of acoustic output, methods of measurement and characterization of the pressure field, and guidance for appropriate hydrophone and test‑setup selection. It explicitly does not apply to percutaneous or laser lithotripsy, histotripsy, long‑duration therapeutic ultrasound bursts, or non‑focused pressure pulse equipment. IEC 61846:2025 cancels and replaces IEC 61846:1998.

Key topics and requirements

• Updated terminology: "therapeutic focused short pressure pulse sources" replaces older "pressure pulse lithotripters" to reflect expanded clinical uses.
• Definition and measurement of primary acoustic parameters (peak compressional/rarefactional pressures, pulse energy, spatial focal dimensions using −n dB contours and n MPa contours).
• New derived and descriptive metrics: momentum, average positive acoustic pressure, cavitation induction index, pulse‑to‑pulse variability, total pressure pulse energy dose.
• Measurement method requirements: hydrophone selection and calibration guidance, test‑chamber and positioning recommendations, data acquisition and uncertainty considerations tailored to short pressure pulses.
• Guidance on reporting and declaration of acoustic output for manufacturers, including parameters suitable for device labeling and technical files.
• Explicit exclusions and relationship to adjacent standards (to avoid overlap with non‑focused pulse, HIFU/HITU and other ultrasound standards).

Typical use and users

Primary users are manufacturers of extracorporeal focused short pressure‑pulse therapy systems (including modern lithotripsy and expanded therapeutic applications), test and calibration laboratories, regulatory and conformity assessment bodies, clinical engineers, and researchers developing or validating focused pressure‑pulse treatments. The standard is used to design measurement protocols, prepare acoustic output declarations, and support regulatory submissions and quality assurance programs.

Related standards

Standards frequently referenced with IEC 61846:2025 include: IEC 63045 (characteristics of non‑focusing short pressure pulse sources — for non‑focused/ballistic devices), IEC 62127‑1 (hydrophone measurement and characterization practices for medical ultrasonic fields), and medical‑safety standards for therapeutic ultrasound equipment such as IEC 60601‑2‑62 for HITU where scope overlaps are relevant. These documents provide complementary metrology, measurement‑device and safety requirements used together with IEC 61846 for a complete test and compliance program.

Keywords

Focused pressure pulse; lithotripsy; therapeutic ultrasound; acoustic field characterization; hydrophone; peak compressional pressure; peak rarefactional pressure; −n dB; n MPa contours; cavitation induction index; pulse energy; metrology; TC 87 Ultrasonics.

FAQ

Q: What is this standard?

A: IEC 61846:2025 is an international standard that defines how to measure, characterize and declare the acoustic output and field properties of extracorporeally generated focused short pressure‑pulse therapeutic devices.

Q: What does it cover?

A: It covers measurable acoustic parameters, derived metrics, measurement setups and hydrophone guidance for focused short pressure‑pulse sources used in therapy (including applications beyond traditional lithotripsy). It excludes percutaneous and laser lithotripsy, histotripsy and long‑duration ultrasound bursts, and non‑focused pulse sources.

Q: Who typically uses it?

A: Device manufacturers, test and calibration laboratories, clinical engineers, researchers, and regulatory/standards bodies use the standard for product development, acoustic characterization, QA and conformity demonstration.

Q: Is it current or superseded?

A: IEC 61846:2025 is the current edition published on 30 January 2025 and it cancels and replaces IEC 61846:1998. The earlier edition was withdrawn when the 2025 edition was published.

Q: Is it part of a series?

A: It is maintained by IEC technical committee TC 87 (Ultrasonics) and sits alongside related IEC documents covering non‑focused pressure pulses (IEC 63045), hydrophone metrology (IEC 62127‑1), and medical‑electrical safety for therapeutic ultrasound (for example IEC 60601‑2‑62 for HITU). These related standards are commonly used in combination depending on device type and application.

Q: What are the key keywords?

A: Focused short pressure pulse, lithotripsy, therapeutic ultrasound, acoustic characterization, hydrophone, peak pressure, pulse energy, cavitation index, −n dB, n MPa.