EN 61685:2001
(Main)Ultrasonics - Flow measurement systems - Flow test object
Ultrasonics - Flow measurement systems - Flow test object
Specifies parameters for a flow Doppler test object representing a blood vessel of known diameter at a certain depth in human tissue, carrying a steady flow. Establishes a flow Doppler test object which can be used to assess various aspects of the performance of Doppler diagnostic equipment.
Ultraschall - Durchflussmesssysteme - Durchfluss-Doppler-Prüfobjekt
Ultrasons - Systèmes de mesure de débit - Montage pour essai de débit
Ultrasonics - Flow measurement systems - Flow test object (IEC 61685:2001)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2002
Ultrasonics - Flow measurement systems - Flow test object (IEC 61685:2001)
Ultrasonics - Flow measurement systems - Flow test object
Ultraschall - Durchflussmesssysteme - Durchfluss-Doppler-Prüfobjekt
Ultrasons - Systèmes de mesure de débit - Montage pour essai de débit
Ta slovenski standard je istoveten z: EN 61685:2001
ICS:
17.120.01 0HUMHQMHSUHWRNDWHNRþLQQD Measurement of fluid flow in
VSORãQR general
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 61685
NORME EUROPÉENNE
EUROPÄISCHE NORM October 2001
ICS 17.140.50
English version
Ultrasonics -
Flow measurement systems -
Flow test object
(IEC 61685:2001)
Ultrasons - Ultraschall -
Systèmes de mesure de débit - Durchflussmesssysteme -
Montage pour essai de débit Durchfluss-Doppler-Prüfobjekt
(CEI 61685:2001) (IEC 61685:2001)
This European Standard was approved by CENELEC on 2001-09-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61685:2001 E
Foreword
The text of document 87/202/FDIS, future edition 1 of IEC 61685, prepared by IEC TC 87, Ultrasonics,
was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 61685 on
2001-09-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2002-06-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2004-09-01
Annexes designated "normative" are part of the body of the standard.
Annexes designated "informative" are given for information only.
In this standard, annexes B and ZA are normative and annexes A, C, D, E and F are informative.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 61685:2001 was approved by CENELEC as a European
Standard without any modification.
__________
- 3 - EN 61685:2001
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of any
of these publications apply to this European Standard only when incorporated in it by amendment or
revision. For undated references the latest edition of the publication referred to applies (including
amendments).
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
IEC 61102 1991 Measurement and characterisation of EN 61102 1993
ultrasonic fields using hydrophones in
the frequency range 0,5 MHz to 15 MHz
IEC 61206 1993 Ultrasonics - Continuous-wave Doppler EN 61206 1995
systems - Test procedures
IEC 61895 1999 Ultrasonics - Pulsed Doppler diagnostic--
systems - Test procedures to determine
performance
INTERNATIONAL IEC
STANDARD
First edition
2001-07
Ultrasonics –
Flow measurement systems –
Flow test object
Ultrasons –
Systèmes de mesure de débit –
Montage pour essai de débit
IEC 2001 Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
W
International Electrotechnical Commission
For price, see current catalogue
– 2 – 61685 IEC:2001(E)
CONTENTS
FOREWORD . 4
INTRODUCTION .5
1 Scope . 6
2 Normative references . 6
3 Definitions. 6
4 List of symbols . 11
5 General outline of flow Doppler test object. 12
6 Specification of the flow Doppler test object. 12
6.1 General. 12
6.2 Blood-mimicking fluid (BMF). 13
6.3 Tube . 14
6.4 Tissue-mimicking material (TMM). 15
6.5 Geometry. 15
7 Precautions to prevent changes in the composition of the blood-mimicking fluid
(BMF) . 15
8 Specifications for labelling. 16
Annex A (informative) Rationale concerning the position of this standard. 17
Annex B (normative) Formulae relating various quantities . 20
Annex C (informative) Rationale for the numerical values chosen in this standard . 21
Annex D (informative) Description of an example flow Doppler test object . 23
Annex E (informative) Schematic diagram of a possible flow circuit . 32
Annex F (informative) Measuring methods . 33
Bibliography . 34
Figure 1 – Three configurations for Doppler flow test objects. 12
Figure D.1 – The main elements of a flow test object . 24
Figure D.2 – Backscattering coefficient of BMF as a function of frequency . 26
Figure D.3 – Attenuation of TMM () and BMF ({{) as a function of frequency . 26
Figure D.4 – Attenuation of ultrasound by material of tube wall, as a function of
frequency . 27
Figure D.5 – Deformation of velocity spectrum of parabolic flow by attenuation due to
tube wall (wall thickness 1,5 mm). 28
Figure D.6 – Backscattering coefficient of two samples of TMM as a function of
frequency . 29
Figure D.7 – The quotient of attenuation by TMM (1-way passage) and frequency as a
function of frequency . 29
Figure D.8 – Testing for penetration depth . 31
Figure E.1 – Schematic diagram of a possible flow circuit, showing the place of the flow
Doppler test object . 32
61685 IEC:2001(E) – 3 –
Table 1 – Typical ranges of parameters for blood at 37 °C, where f is the acoustic-
working frequency in hertz . 13
Table 2 – Specification of blood-mimicking fluid (BMF). 13
Table 3 – Parameters of tissue-mimicking material (TMM) . 15
Table A.1 – Parameters concerning CW Doppler . 18
Table A.2 – Additional parameters concerning pulsed Doppler and colour flow . 19
– 4 – 61685 IEC:2001(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ULTRASONICS – FLOW MEASUREMENT SYSTEMS –
FLOW TEST OBJECT
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 specifications, 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 61685 has been prepared by IEC Technical Committee 87:
Ultrasonics.
The text of this standard is based on the following documents:
FDIS Report on voting
87/202/FDIS 87/208/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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annexes A, C, D, E and F are for information only.
Annex B forms an integral part of this standard.
The committee has decided that the contents of this publication will remain unchanged until
2006. At this date, the publication will be
reconfirmed;
withdrawn;
replaced by a revised edition, or
amended.
61685 IEC:2001(E) – 5 –
INTRODUCTION
The purpose of this International Standard is to establish a flow Doppler test object for the
acceptance testing, quality assurance testing and clinical calibration of Doppler systems,
working at a frequency between 2 MHz and 10 MHz. As the response of Doppler systems
depends on the signal level and on the spectral contents of the signal, it is desirable to test
some aspects of a Doppler system with a test object that mimics the in vivo situation. A flow
Doppler test object is particularly useful for
− testing the influence of the size and the depth of the blood vessel on the signal recorded by
a Doppler system;
− testing the response of a Doppler system with a spectrum of blood velocities typical of the
in vivo situation.
This flow test object is not intended as a phantom mimicking clinical conditions.
The basis of this In
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