IEC 61847-1998 PDF

Full title and description

IEC 61847:1998 — Ultrasonics — Surgical systems — Measurement and declaration of the basic output characteristics. This International Standard specifies the essential non‑thermal output characteristics of ultrasonic surgical units, methods for measuring those characteristics, and the parameters manufacturers should declare for such equipment.

Abstract

IEC 61847:1998 defines measurement procedures and declaration requirements for non‑thermal acoustic output of ultrasonic surgical systems that deliver energy via a waveguide to a surgical site (typical operating range 20 kHz to 60 kHz in the 1998 edition). It focuses on parameters such as acoustic power, tip vibration excursions and other non‑thermal output characteristics, and provides standardized methods to ensure repeatable, comparable measurements and transparent manufacturer declarations.

General information

• Status: Superseded / withdrawn — a revised edition (IEC 61847:2025) has been published and the 1998 edition was taken out of force in 2025.
• Publication date: First edition published January 1998 (IEC publication date shown as 1998‑01‑30).
• Publisher: International Electrotechnical Commission (IEC), Technical Committee TC 87 (Ultrasonics).
• ICS / categories: 11.040.01 (Medical equipment in general); 17.140.50 (Electroacoustics).
• Edition / version: Edition 1.0 (1998).
• Number of pages: 31 pages (base IEC publication).

Scope

The 1998 edition applies to ultrasonic surgical systems that (a) operate in the low‑frequency ultrasonic range (20 kHz to 60 kHz in the original edition), (b) are used for fragmentation, cutting or removal of human tissue (with or without concomitant coagulation), and (c) deliver acoustic energy to the surgical site via a specifically designed waveguide. The standard specifies which non‑thermal output characteristics are of interest, how to measure them and which characteristics should be declared by manufacturers. (Note: the 2025 revision expands and updates frequency limits, measurement methods and coverage.)

Key topics and requirements

• Definition and selection of essential non‑thermal output characteristics for ultrasonic surgical units (e.g., acoustic output power, primary and secondary tip vibration excursions, directivity characteristics).
• Standardized measurement procedures, including preparation and operating/load conditions, and specific test methods for tip vibration excursion and acoustic power.
• Requirements for manufacturer declarations of measured output parameters to support transparency and comparability.
• Guidance on adapting measurement methodology to different applicator tip shapes and complex vibration patterns (scope limited in 1998 edition; expanded in 2025 edition).
• Notes on limitations — the 1998 edition addresses only low‑frequency components (under 100 kHz) of delivered energy and does not attempt to assess effectiveness or safety in clinical use.

Typical use and users

Primary users include manufacturers of ultrasonic surgical systems (for product design and label declarations), accredited test and calibration laboratories (for acoustic output verification), regulatory and conformity assessment bodies (for evaluation of declared output), clinical engineers and hospital biomedical teams (for equipment acceptance and QA), and researchers developing or characterizing surgical ultrasonic devices.

Related standards

IEC 61847 sits within a family of ultrasonics and medical ultrasound standards developed by TC 87 and adjacent IEC committees. Commonly referenced related standards include IEC 62127 (hydrophones and acoustic field measurement), IEC 61161 (radiation force balance power measurement), IEC 61689 (physiotherapy systems), IEC 61828 (transducer definitions and measurement), IEC 61846 (pressure pulse/lithotripter fields), IEC 62359 (field characterization/indices), and relevant parts of the IEC 60601 series addressing medical electrical equipment safety (e.g., IEC 60601‑2‑37, IEC 60601‑2‑62).

Keywords

ultrasonics; surgical systems; acoustic output; non‑thermal output characteristics; hydrophone; vibration excursion; acoustic power; waveguide; applicator tip; measurement methods; TC 87.

FAQ

Q: What is this standard?

A: IEC 61847:1998 is an IEC International Standard that defined methods for measuring and declaring the basic non‑thermal output characteristics of ultrasonic surgical systems (first published in January 1998).

Q: What does it cover?

A: It covers which non‑thermal output parameters to measure (for example, acoustic output power and tip vibration excursions), how to perform those measurements under specified conditions, and which values manufacturers should declare. It applies to surgical ultrasonic systems delivering acoustic energy via a waveguide for tissue cutting/fragmentation in the specified frequency range.

Q: Who typically uses it?

A: Manufacturers, test laboratories, regulatory/conformity assessors, clinical engineers, and researchers working with surgical ultrasonic devices.

Q: Is it current or superseded?

A: The 1998 edition has been superseded by a revised edition (IEC 61847:2025). The IEC web catalogue lists a withdrawal date for the 1998 edition of 20 May 2025; various national/adopted versions show withdrawal or replacement dates in mid‑2025 (for example 1 July or 15 July 2025 in some catalogs). Users should refer to IEC 61847:2025 for the current, authoritative technical requirements.

Q: Is it part of a series?

A: Yes — it is part of the IEC ultrasonics family developed under TC 87 and is closely related to other measurement and medical‑ultrasound standards (IEC 62127, IEC 61161, IEC 61846, IEC 61828, IEC 62359, and relevant IEC 60601 parts). These documents together support measurement, reporting and safety considerations for diagnostic, therapeutic and surgical ultrasound equipment.

Q: What are the key keywords?

A: Ultrasonics; surgical systems; acoustic output; non‑thermal; hydrophone; measurement; vibration excursion; acoustic power; applicator tip; waveguide.