EN 61847:1998
(Main)Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
This standard specifies: - the essential non-thermal output characteristics of ultrasonic surgical units; - methods of measurement ot these output characteristics; - those characteristics which should be declared by the manufacturers of such equipment. This standard is applicable to equipment which meets the requirements of a, b and c below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and b) ultrasonic surgical systems, whose use is the fragmentation 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.
Ultraschall - Chirurgische Systeme - Messung und Deklaration der grundlegenden Ausgangsrößen
Ultrasons - Systèmes de chirurgie - Mesure et déclaration des caractéristiques de sortie
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics (IEC 61847:1998)
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SLOVENSKI STANDARD
01-september-2002
Ultrasonics - Surgical systems - Measurement and declaration of the basic output
characteristics (IEC 61847:1998)
Ultrasonics - Surgical systems - Measurement and declaration of the basic output
characteristics
Ultraschall - Chirurgische Systeme - Messung und Deklaration der grundlegenden
Ausgangsrößen
Ultrasons - Systèmes de chirurgie - Mesure et déclaration des caractéristiques de sortie
Ta slovenski standard je istoveten z: EN 61847:1998
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.
INTERNATIONAL
IEC
STANDARD
First edition
1998-01
Ultrasonics – Surgical systems –
Measurement and declaration of the basic
output characteristics
Ultrasons – Systèmes de chirurgie –
Mesure et déclaration des caractéristiques
de sortie
IEC 1998 Droits de reproduction réservés Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun any form or by any means, electronic or mechanical,
procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
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Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE V
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue
– 2 – 61847 © IEC:1998 (E)
CONTENTS
Page
FOREWORD . 3
INTRODUCTION . 4
Clause
1 Scope . 5
2 Normative references. 5
3 Definitions. 6
4 List of symbols. 9
5 General measurement requirements. 9
5.1 Operating conditions . 9
5.2 Load conditions. 9
5.3 Preparation for measurements . 10
6 Measurement procedures. 10
6.1 Primary tip vibration excursion . 10
6.2 Secondary tip vibration excursion . 11
6.3 Drive frequency. 11
6.4 Tip vibration frequency. 11
6.5 Derived output acoustic power and output acoustic power . 12
6.6 Directivity pattern. 13
6.7 Primary tip vibration excursion modulation. 13
6.8 Duty cycle. 14
6.9 Quiescent electrical power . 14
6.10 Maximum electrical power. 14
6.11 Primary acoustic output area. 15
6.12 Secondary acoustic output area . 15
6.13 Power reserve index . 15
7 Declaration of output characteristics. 15
Figures. 16
Annexes
A Measurement methods and conditions. 21
B Theory of operation of ultrasonic surgical devices. 26
C Bibliography. 29
61847 © IEC:1998 (E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
__________
ULTRASONICS – SURGICAL SYSTEMS –
Measurement and declaration of the basic output characteristics
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61847 has been prepared by IEC technical committee 87:
Ultrasonics.
The text of this standard is based on the following documents:
FDIS Report on voting
87/114/FDIS 87/117/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annexes A, B and C are for information only.
In this standard the following print types are used:
– Requirements: in roman type
– Test specifications: in italic type
– Notes: in small roman type
– Words in bold in the text are defined in clause 3.
A bilingual version of this standard may be issued at a later date.
– 4 – 61847 © IEC:1998 (E)
INTRODUCTION
Ultrasonic surgical systems, operating in the 20 kHz to 60 kHz range, are used widely in
ophthalmology and neurosurgery to fragment or disintegrate and aspirate unwanted tissue.
Their commercial use in ophthalmology started in 1970. Their application in neurosurgery
followed about 10 years later. Ultrasonic surgical systems are also widely used in oncology
surgery.
This International Standard defines the parameters which characterize the output and
performance of open and closed site ultrasonic surgical systems, and indicates which
parameters should be declared. In addition, measurement procedures are described so that
technically qualified people will be able to report on the parameters in a uniform and
understandable fashion. An open surgical site is one in which the incision is large relative to
the size of the applicator tip being inserted thus precluding any increase in pressure of the
organ due to an imbalance of irrigant flow and suction flow. An example of a closed surgical
site is an eye where the incision is closely controlled.
This International Standard does not provide any guidance on what is the resultant safety or
efficacy of devices described by these parameters since very little scientifically controlled data
are available by which such judgements can be made.
61847 © IEC:1998 (E) – 5 –
ULTRASONICS – SURGICAL SYSTEMS –
Measurement and declaration of the basic output characteristics
1 Scope
This International Standard specifies:
– the essential non-thermal output characteristics of ultrasonic surgical units;
NOTE 1 – One of the parameters of interest is output acoustic power. This standard addresses only the low-
frequency (under 100 kHz) component of the total delivered energy. The high-frequency component, which probably
relates to cavitation developed at the tip, is not addressed (see A.4).
– methods of measurement of these output characteristics;
– those characteristics which should be declared by the manufacturers of such equipment.
NOTE 2 – In the interest of clarity, this standard does not address all of the complex surfaces and shapes possible
for applicator tips. A straight tubular shape is used in the description of the parameters and measurements to be
made. It is left to the user of this standard to adapt the basic methodology described to more complex designs if
required.
This International Standard is applicable to equipment which meets the requirements of a, b
and c below:
a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and
b) ultrasonic surgical systems, whose use is the fragmentation 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.
NOTE 3 – Examples of these types of systems are surgical aspirators, intracorporeal lithotripters, end-cutting
devices etc.
This International Standard is not applicable to:
– lithotripsy equipment which uses extracorporeally induced pressure pulses, focussed
through liquid conducting media and the soft tissues of the body;
– surgical devices used as part of the therapeutic process (hyperthermia systems);
– surgical devices whose acoustic application areas are not at the end of a longitudinally
vibrating applicator tip and therefore would not fit the monopole model used in this standard.
This International Standard does not deal with the effectiveness or safety of ultrasonic surgical
systems.
NOTE 4 – Throughout this standard, the term accuracy means the overall uncertainty expressed at the 95 %
confidence level.
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this International Standard. At the time of publication, the editions
indicated were valid. All normative documents are subject to revision, and parties to
agreements based on this International Standard are encouraged to investigate the possibility
of applying the most recent editions of the normative documents indicated below. Members of
IEC and ISO maintain registers of currently valid International Standards.
IEC 60500:1974, IEC standard hydrophone
IEC 61205:1993, Ultrasonics – Dental descaler systems – Measurement and declaration of the
output characteristics
– 6 – 61847 © IEC:1998 (E)
3 Definitions
For the purpose of this International Standard, the following definitions apply.
3.1
applicator tip; applied part
that part of the surgical tool which comes into direct contact with body tissues
3.2
directivity pattern
normalized variation in acoustic pressure as a function of angle at constant range from the
applicator tip
NOTE – This parameter is important when operating adjacent to body structures which are sensitive to pressure
and motion such as the endothelial cells on the inside of the cornea or acoustic nerves.
Symbol: p
fd
Unit: dimensionless plot
3.3
drive frequency
mean frequency of the driving voltage or current
NOTE – This parameter, coupled with tip vibration excursion, allows the user to compare the velocities of applicator
tips.
Symbol: f
d
Unit: kilohertz, kHz
3.4
duty cycle
for those systems which modulate the electrical drive power, the ratio of the voltage or current
pulse duration (on time) to the duration of one complete modulation cycle while the equipment
is active
Symbol: D
cy
Unit: dimensionless
3.5
maximum electrical power
the peak input electrical power to the ultrasonic handpiece when the load on the applicator tip
is gradually increased from its quiescent condition
NOTE – The peak electrical power occurs at the point at which a reduction in the primary tip vibration excursion
from its value co
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