prEN IEC 61847:2024
(Main)Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
Ultraschall - Chirurgische Systeme - Messung und Deklaration der grundlegenden Ausgangsrößen
Ultrasons - Systèmes chirurgicaux - Mesurage et déclaration des caractéristiques d'émission de base
Ultrazvok - Kirurški sistemi - Merjenje in navajanje osnovnih izhodnih karakteristik
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2024
Ultrazvok - Kirurški sistemi - Merjenje in navajanje osnovnih izhodnih karakteristik
Ultrasonics - Surgical systems - Measurement and declaration of the basic output
characteristics
Ultraschall - Chirurgische Systeme - Messung und Deklaration der grundlegenden
Ausgangsrößen
Ultrasons - Systèmes chirurgicaux - Mesurage et déclaration des caractéristiques
d'émission de base
Ta slovenski standard je istoveten z: prEN IEC 61847:2024
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.
87/870/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61847 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-07-19 2024-10-11
SUPERSEDES DOCUMENTS:
87/835/CD, 87/866/CC
IEC TC 87 : ULTRASONICS
SECRETARIAT: SECRETARY:
United Kingdom Mr Petar Luzajic
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some
Countries” clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is
the final stage for submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Ultrasonics - Surgical systems - Measurement and declaration of the basic output
characteristics
PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
87/870/CDV – 2 – IEC CDV 61847 © IEC 2024
2 CONTENTS
4 FOREWORD. 4
5 INTRODUCTION . 5
6 1 Scope . 6
7 2 Normative references . 7
8 3 Definitions . 8
9 4 List of symbols . 12
10 5 General measurement requirements . 12
11 5.1 Operating conditions . 12
12 5.2 Load conditions . 12
13 5.2.1 For measurement of output acoustic power . 12
14 5.3 Preparation for measurements . 13
15 5.3.1 Preparation of the applicator . 13
16 5.3.2 Preparation of the water . 13
17 5.3.3 Preparation of the system. 13
18 6 Measurement procedures . 13
19 6.1 Primary tip vibration excursion . 13
20 6.1.1 Optical microscope method . 13
21 6.1.2 Laser vibrometer method . 13
22 6.1.3 Feedback voltage method . 14
23 6.2 Secondary tip vibration excursion . 14
24 6.2.1 Optical microscope . 14
25 6.3 Drive frequency . 14
26 6.3.1 Frequency counter method . 14
27 6.3.2 Spectrum analyser method . 14
28 6.4 Tip vibration frequency . 14
29 6.4.1 Vibrometer method . 15
30 6.4.2 Hydrophone method . 15
31 6.5 Output acoustic power . 15
32 6.5.1 Output acoustic power – Hydrophone method . 15
33 6.5.2 Output acoustic power – Calorimeter method . 16
34 6.6 Directivity pattern . 16
35 6.7 Primary tip vibration excursion modulation . 17
36 6.7.1 Laser vibrometer method . 17
37 6.8 Duty cycle . 18
38 6.9 Primary acoustic output area . 19
39 6.10 Secondary acoustic output area . 19
40 7 Declaration of output characteristics . 19
41 Annex A (informative) . 26
42 A.1 Optical microscope method . 26
43 A.2 Vibrometer method . 26
44 A.3 Output acoustic power using the calorimeter method . 26
45 A.4 Output acoustic power using the pressure method . 27
46 A.5 Feedback voltage method . 27
47 A.6 Influence of air bubbles and contaminations . 28
48 A.7 Test tank . 28
49 A.8 Derivation of formula for output acoustic power for the case of a dipole . 28
50 Annex B (informative) . 31
51 B.1 Introduction . 31
87/870/CDV – 3 – IEC CDV 61847 © IEC 2024
52 B.2 System description . 31
53 B.3 Possible mechanisms of tissue interaction . 32
54 B.4 Typical values of output and discussion of parameters . 32
55 B.5 Operating conditions . 33
56 Bibliography . 34
58 Figure 1 – Measuring the primary and secondary tip vibration excursion . 21
59 Figure 2 – Example of a primary acoustic output area . 22
60 Figure 3 – Measuring the pressure field . 23
61 Figure 4 – Illustration of the method of determining duty cycle from an oscilloscope
62 trace. The dotted line is at a level equal to the minimum peak-to-peak level plus 10 %
63 of the difference between the maximum and the minimum peak-to-peak levels . 24
64 Figure A.1 – A typical relationship between tip vibration amplitude and acoustic output.
65 Measurements should be taken in region A, and extrapolated to Region C. From
66 Schafer, 2023. . 30
67 Figure A.2 – Schematic diagram of the theoretical model geometry for . the tip immersed
68 below the surface of the water . 30
87/870/CDV – 4 – IEC CDV 61847 © IEC 2024
71 INTERNATIONAL ELECTROTECHNICAL COMMISSION
72 __________
74 ULTRASONICS – SURGICAL SYSTEMS –
75 Measurement and declaration of the basic output characteristics
79 FOREWORD
80 1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
81 all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
82 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
83 this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
84 entrusted to technical committees; any IEC National Committee interested in the subject dealt with can participate
85 in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC
86 also participate in this preparation. The IEC collaborates closely with the International Organization for
87 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
88 2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
89 international consensus of opinion on the relevant subjects since each technical committee has representation
90 from all interested National Committees.
91 3) The documents produced have the form of recommendations for international use and are published in the form
92 of standards, technical reports or guides and they are accepted by the National Committees in that sense.
93 4) In order to promote international unification, IEC National Committees undertake to apply IEC International
94 Standards transparently to the maximum extent possible in their national and regional standards. Any divergence
95 between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the
96 latter.
97 5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
98 equipment declared to be in conformity with one of its standards.
99 6) Attention is drawn to the possibility that some of the elements of this International Standard can be the subject
100 of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
101 International Standard IEC 61847 has been prepared by IEC technical committee 87:
102 Ultrasonics.
103 The text of this standard is based on the following documents:
FDIS Report on voting
87/XXX/FDIS 87/XXX/RVD
105 Full information on the voting for the approval of this standard can be found in the report on
106 voting indicated in the above table.
107 Annexes A, B and C are for information only.
108 In this standard the following print types are used:
109 – Requirements: in roman type
110 – Test specifications: in italic type
111 – Notes: in small roman type
112 – Words in bold in the text are defined in clause 3.
113 A bilingual version of this standard is expected to be issued at a later date.
87/870/CDV – 5 – IEC CDV 61847 © IEC 2024
115 INTRODUCTION
117 Ultrasonic surgical systems, operating in the 20 kHz to 120 kHz range, are used widely in
118 ophthalmology and neurosurgery to fragment or disintegrate and aspirate unwanted tissue.
119 Their commercial use in ophthalmology started in 1970. Their application in neurosurgery
120 followed about 10 years later. Ultrasonic surgical systems are also widely used in oncology
121 surgery. The use of these devices has expanded to areas such as liposuction and wound
122 treatments.
123 This International Standard defines the parameters which characterize the output and
124 performance of open and closed site ultrasonic surgical systems, and indicates which
125 parameters should be declared. In addition, measurement procedures are describ
...
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