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DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Overview

Several different types of devices for lithotripsy and ESWT from a variety of manufacturers are commercially available. This International Standard specifies methods for measuring and characterizing the sound pressure field generated by focused pressure pulse devices. This document does not apply to percutaneous and laser lithotripsy equipment; histotripsy or other therapeutic ultrasound bursts of longer time duration than that of the non-focused pressure pulse equipment. The standard differs from DIN EN 61846:1999-04 as follows: a) change of title: "pressure pulse lithotripters" in the previous edition is changed to "therapeutic focused short pressure pulse sources" in order to take into account the development in the relevant technical and biomedical applications of such sources, which were originally used only for (kidney) lithotripsy, while recent applications include a wide range for the treatment of, for example, stone diseases, orthopaedic pain, tissue, cardiac and brain diseases. The term "focused" was added to differentiate IEC 61846 from IEC 63045. The term "short" was added to align the nomenclature to IEC 63045 and to differentiate IEC 61846 from standards in the HIFU and HITU fields; b) Clause 1 and elsewhere in the document: The term "lithotripsy" is changed to "therapy" in order to account for the wide range of applications beyond stone diseases; c) Clause 3: The "-6 dB" parameter definitions are replaced by "-n dB" to avoid misconceptions in the significance and use of these parameters and to account for newer findings in literature. Additional "n MPa" parameters are introduced for the same reasons. The definitions of "derived" parameters are aligned to those in recently published standards, for example IEC 62127-1. New definitions were added which describe parameters appearing in newer relevant literature, for example "momentum", "average positive acoustic pressure", "cavitation induction index", "pulse to pulse variability", "total pressure pulse energy dose"; d) Clause 6: The terms "focus hydrophone" and "field hydrophone" were removed to account for newer technical developments. New terms distinguish between "hydrophones for pressure pulse measurements" and "hydrophones for quality assurance"; e) Annexes: Descriptions, tables and figures were edited to account for newer literature and standards as well as technical developments. This International Standard applies to: therapeutic devices that use extracorporeally induced focused pressure pulse waves; therapeutic devices designed to generate focused mechanical energy without thermal energy.

Responsible national committee

DKE/GUK 821.3 - Medizinische Ultraschallgeräte