EN IEC 61847:2025
(Main)Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
IEC 61847:2025 specifies: – the essential non-thermal output characteristics of ultrasonic surgical units; – methods of measurement of these output characteristics; – those characteristics to be declared by the manufacturers of such equipment. This document is applicable to equipment which meets the criteria of a), b) and c) below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site. This document is not applicable to: – lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body; – surgical systems used as part of the therapeutic process (hyperthermia systems); – surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters; – surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer; – surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling. This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients. IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz. b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach. c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this. d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed. e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described. f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics. g) Guidance is provided with respect to measurement tank arrangements for different types of systems. h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments. i) Definitions for cavitation related terms were added. j) Requirements for the measurement of directivity characteristics of the applicator tip were changed. k) Annex A was modified and Figure A.1 wa
Ultraschall - Chirurgische Systeme - Messung und Deklaration der grundlegenden Ausgangsrößen
Ultrasons - Systèmes chirurgicaux - Mesurage et déclaration des caractéristiques d'émission de base
IEC 61847:2025 spécifie: – les caractéristiques d'émission non thermiques essentielles des unités chirurgicales à ultrasons; – les méthodes de mesure de ces caractéristiques d'émission; – les caractéristiques de ces appareils que les fabricants doivent déclarer. Le présent document s'applique aux appareils qui respectent les critères a), b) et c) ci-dessous: a) systèmes chirurgicaux à ultrasons fonctionnant dans la plage de fréquences de 20 kHz à 120 kHz; et b) systèmes à ultrasons appliqués à la fragmentation, à l'émulsification, au débridement ou à la découpe de tissus humains, ces effets étant ou non utilisés conjointement avec l'élimination ou la coagulation des tissus; et c) systèmes chirurgicaux à ultrasons dans lesquels une onde acoustique est guidée par un guide d'onde spécial afin d'apporter de l'énergie au site chirurgical. Le présent document ne s'applique pas: – aux appareils de lithotripsie employant des pulsations de pression induites par voie extracorporelle, focalisées à travers un liquide conducteur et dans les tissus mous du corps; – aux systèmes chirurgicaux utilisés dans des procédés thérapeutiques (systèmes d'hyperthermie); – aux systèmes chirurgicaux dont le mécanisme d'action repose sur la chaleur de friction générée par les tissus en contact avec le guide d'onde, par exemple pinces à coagulation ou pinces de coupe vibratoires; – aux systèmes chirurgicaux dont le mécanisme d'action repose sur l'application d'ultrasons pour assurer la dégradation thermique (ultrasons focalisés de haute intensité – UFHI) ou l'érosion par cavitation (histotripsie) des tissus à distance du transducteur à ultrasons; – aux systèmes chirurgicaux dont le mécanisme d'action repose sur l'érosion des tissus durs en contact avec l'embout applicateur, par exemple pour découper ou percer des os. Le présent document ne traite pas de l'efficacité ou de la sécurité des systèmes chirurgicaux à ultrasons. Le présent document ne traite pas non plus du bruit aérien émis par les systèmes, qui peut affecter les opérateurs et les patients. IEC 61847:2025 annule et remplace la première édition parue en 1998. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) la fréquence supérieure couverte par le présent document a été portée de 60 kHz à 120 kHz; b) la méthode de l'hydrophone pour mesurer la puissance des ultrasons a désormais une valeur normative. En raison des difficultés liées à l'utilisation de la méthode de mesurage de la puissance des ultrasons par calorimétrie, celle-ci n'est plus l'approche principale; c) il est reconnu que certains systèmes peuvent disposer de plusieurs modes de vibration sous le contrôle de l'utilisateur, et les techniques de mesurage et les déclarations ont été mises à jour en ce sens; d) la composante à haute fréquence, qui est liée à l'apparition de cavitation au niveau de l'embout applicateur, et l'amplitude vibratoire à laquelle la cavitation apparaît sont étudiées; e) des exigences spécifiques pour le mesurage à des niveaux de déplacement auxquels il n'y a pas de phénomène de cavitation ainsi que l'extrapolation aux niveaux de déplacement maximaux sont définies; f) des recommandations sont fournies pour adapter la méthodologie décrite à des conceptions et des motifs v
Ultrazvok - Kirurški sistemi - Merjenje in navajanje osnovnih izhodnih karakteristik (IEC 61847:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2025
Nadomešča:
SIST EN 61847:2002
Ultrazvok - Kirurški sistemi - Merjenje in navajanje osnovnih izhodnih karakteristik
(IEC 61847:2025)
Ultrasonics - Surgical systems - Measurement and declaration of the basic output
characteristics (IEC 61847:2025)
Ultraschall - Chirurgische Systeme - Messung und Deklaration der grundlegenden
Ausgangsrößen (IEC 61847:2025)
Ultrasons - Systèmes chirurgicaux - Mesurage et déclaration des caractéristiques
d'émission de base (IEC 61847:2025)
Ta slovenski standard je istoveten z: EN IEC 61847:2025
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 61847
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2025
ICS 11.040.01; 17.140.50 Supersedes EN 61847:1998
English Version
Ultrasonics - Surgical systems - Measurement and declaration of
the basic output characteristics
(IEC 61847:2025)
Ultrasons - Systèmes chirurgicaux - Mesurage et Ultraschall - Chirurgische Systeme - Messung und
déclaration des caractéristiques d'émission de base Deklaration der grundlegenden Ausgangsrößen
(IEC 61847:2025) (IEC 61847:2025)
This European Standard was approved by CENELEC on 2025-06-24. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61847:2025 E
European foreword
The text of document 87/894/FDIS, future edition 2 of IEC 61847, prepared by TC 87 "Ultrasonics"
was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-07-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-07-31
document have to be withdrawn
This document supersedes EN 61847:1998 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61847:2025 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-1 NOTE Approved as EN 60601-1
IEC 80601-2-58 NOTE Approved as EN IEC 80601-2-58
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60500 - Underwater acoustics - Hydrophones - Properties EN 60500 -
of hydrophones in the frequency range 1 Hz to 500
kHz
IEC 61847 ®
Edition 2.0 2025-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Ultrasonics – Surgical systems – Measurement and declaration of the basic
output characteristics
Ultrasons – Systèmes chirurgicaux – Mesurage et déclaration des
caractéristiques d'émission de base
ICS 11.040.01, 17.140.50 ISBN 978-2-8327-0442-4
IEC 61847:2025-05(en-fr)
– 2 – IEC 61847:2025 © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 8
4 List of symbols . 12
5 General measurement requirements . 13
5.1 Operating conditions . 13
5.2 Test conditions for the measurement of acoustic power . 13
5.2.1 General. 13
5.2.2 For systems which make direct contact with tissue . 13
5.2.3 For systems which make minimal contact with tissue . 14
5.2.4 For systems which make no contact with tissue . 14
5.3 Preparation for measurements . 14
5.3.1 Preparation of the applicator . 14
5.3.2 Preparation of the water . 14
5.3.3 Preparation of the system . 14
6 Measurement procedures . 14
6.1 Primary tip vibration excursion . 14
6.1.1 General. 14
6.1.2 Optical microscope method . 14
6.1.3 Laser vibrometer method . 15
6.1.4 Feedback voltage method . 15
6.2 Secondary tip vibration excursion . 15
6.2.1 General. 15
6.2.2 Optical microscope. 15
6.3 Drive frequency . 16
6.3.1 General. 16
6.3.2 Frequency counter method. 16
6.3.3 Spectrum analyser method. 16
6.4 Tip vibration frequency . 16
6.4.1 General. 16
6.4.2 Vibrometer method . 16
6.4.3 Hydrophone method . 16
6.5 Output acoustic power . 17
6.5.1 General. 17
6.5.2 Output acoustic power – Hydrophone method . 17
6.5.3 Output acoustic power – Calorimeter method . 18
6.6 Directivity pattern . 18
6.7 Primary tip vibration excursion modulation . 19
6.7.1 General. 19
6.7.2 Laser vibrometer method . 19
6.8 Duty cycle . 19
6.9 Primary acoustic output area . 20
6.10 Secondary acoustic output area . 20
7 Declaration of output characteristics . 20
IEC 61847:2025 © IEC 2025 – 3 –
Annex A (informative) Measurement methods and conditions . 25
A.1 Optical microscope method . 25
A.2 Vibrometer method . 25
A.3 Output acoustic power using the calorimeter method . 25
A.4 Output acoustic power using the pressure method . 26
A.4.1 General. 26
A.4.2 Measurement experience with ultrasonic surgical systems . 26
A.5 Feedback voltage method . 27
A.6 Influence of air bubbles and contaminations . 27
A.7 Test tank . 27
A.8 Derivation of formula for output acoustic power for the case of a dipole . 27
Annex B (informative) Theory of operation of ultrasonic surgical systems . 30
B.1 Overview . 30
B.2 System description . 30
B.3 Possible mechanisms of tissue interaction. 31
B.4 Typical values of output and discussion of parameters . 31
B.5 Operating conditions . 32
Bibliography . 33
Figure 1 – Measuring the primary and secondary tip vibration excursion . 22
Figure 2 – Example of a primary acoustic output area . 23
Figure 3 – Measuring the pressure field . 23
Figure 4 – Illustration of the method of determining duty cycle from an oscilloscope
trace . 24
Figure A.1 – A typical relationship between tip vibration amplitude and acoustic output . 29
Figure A.2 – Schematic diagram of the theoretical model geometry for the tip immersed
below the surface of the water . 29
– 4 – IEC 61847:2025 © IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS – SURGICAL SYSTEMS –
MEASUREMENT AND DECLARATION OF
THE BASIC OUTPUT CHARACTERISTICS
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical S
...
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