Ultrasonics - Pulsed Doppler diagnostic systems - Test procedures to determine performance

This technical specification describes: - test methods for measuring the performance of pulsed Doppler ultrasound systems; - Doppler test objects for carrying out these tests; and applies to - tests made on an overall pulsed Doppler ultrasound system, a system which is not disassembled or disconnected; - tests made on pulsed Doppler ultrasound systems whether they are stand-alone or as part of another ultrasound equipment.

General Information

Status
Published
Publication Date
07-Oct-1999
Technical Committee
Drafting Committee
Current Stage
PPUB - Publication issued
Start Date
31-Oct-1999
Completion Date
08-Oct-1999
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IEC TS 61895:1999 - Ultrasonics - Pulsed Doppler diagnostic systems - Test procedures to determine performance
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TECHNICAL IEC
SPECIFICATION
TS 61895
First edition
1999-10
Ultrasonics – Pulsed Doppler diagnostic
systems – Test procedures to determine
performance
Ultrasons – Systèmes de diagnostic à effet Doppler pulsés –
Procédures d'essai pour déterminer la performance
Reference number
IEC/TS 61895:1999(E)
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are
available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base
publication incorporating amendments 1 and 2.
Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
• Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

TECHNICAL IEC
SPECIFICATION
TS 61895
First edition
1999-10
Ultrasonics – Pulsed Doppler diagnostic
systems – Test procedures to determine
performance
Ultrasons – Systèmes de diagnostic à effet Doppler pulsés –
Procédures d'essai pour déterminer la performance
 IEC 1999  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
V
International Electrotechnical Commission
For price, see current catalogue

– 2 – TS 61895 © IEC:1999(E)
CONTENTS
Page
FOREWORD . 4
INTRODUCTION .6
Clause
1 Scope . 7
2 Normative references . 7
3 Definitions. 7
4 Symbols . 12
5 Overall tests of complete systems . 12
5.1 General considerations . 12
5.1.1 Types of pulsed Doppler ultrasound systems. 12
5.1.2 Worst-case conditions . 13
5.1.3 Doppler beam axes . 14
5.1.4 Probe/target distance variation and measurement. 14
5.2 Initial conditions . 15
5.2.1 Power supply. 15
5.2.2 Target movement direction . 15
5.2.3 Propagation medium . 15
5.2.4 Penetration depth. 16
5.2.5 Working depth. 16
5.2.6 Focusing . 16
5.2.7 Working Doppler angle . 16
5.2.8 Wall-thump filter cut-off frequency. 17
5.2.9 Transmitter output power. 17
5.2.10 Working pulse repetition frequency (PRF) . 17
5.2.11 Doppler (receiver) gain. 17
5.2.12 Test frequency . 17
5.2.13 Working sample volume length . 17
5.2.14 Doppler signal power measurement. 17
5.3 Zero signal noise level . 17
5.4 Doppler frequency response. 18
5.4.1 Frequency response range . 18
5.4.2 Deviation from flat response . 18
5.4.3 Large signal performance . 18
5.5 Spatial response . 19
5.5.1 Sample volume response . 19
5.6 Sample volume position registration error . 20
5.7 Beam position and orientation . 21
5.8 Intrinsic broadening. 22
5.9 Dead zone. 22
5.10 Acoustic working frequency. 22
5.11 Flow direction separation. 22
5.12 Velocity estimation accuracy . 22

TS 61895 © IEC:1999(E) – 3 –
5.13 Volume flow estimation accuracy. 22
5.14 Maximum, mean, mode and median frequency estimation accuracy. 23
5.15 Velocity waveform indices estimation accuracy. 25
6 Doppler test objects. 26
6.1 Test objects. 26
6.2 Electronic test object . 26
Annex A (normative) Description of pulsed Doppler ultrasound systems. 28
A.1 Single-channel system . 28
A.2 Multi-channel system . 29
A.3 Aliasing . 29
A.4 Duplex and triplex scanners . 29
Bibliography . 32

– 4 – TS 61895 © IEC:1999(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
––––––––––––
ULTRASONICS –
PULSED DOPPLER DIAGNOSTIC SYSTEMS –
TEST PROCEDURES TO DETERMINE PERFORMANCE
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 technical specification may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
The main task of IEC technical committees is to prepare International Standards. In
exceptional circumstances, a technical committee may propose the publication of a technical
specification when
the required support cannot be obtained for the publication of an International Standard,
despite repeated efforts, or
the subject is still under technical development or where, for any other reason, there is the
future but no immediate possibility of an agreement on an International Standard.
Technical specifications are subject to review within three years of publication to decide
whether they can be transformed into International Standards.
IEC 61895, which is a technical specification, has been prepared by IEC technical committee
87: Ultrasonics.
The text of this technical specification is based on the following documents:
Enquiry draft Report on voting
87/151/CDV 87/168/RVC
Full information on the voting for the approval of this technical specification can be found in the
report on voting indicated in the above table.

TS 61895 © IEC:1999(E) – 5 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annex A forms an integral part of this technical specification.
The committee has decided that this publication remains valid until 2005. At this date, in
accordance with the committee’s decision, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition,or
• amended.
A bilingual version of this publication may be issued at a later date.

– 6 – TS 61895 © IEC:1999(E)
INTRODUCTION
Pulsed ultrasonic Doppler flowmeters and velocimeters are widely used in clinical practice,
usually in combination with real-time B-mode imaging and colour-flow imaging instruments.
The device periodically transmits pulses of ultrasound from an ultrasound transducer and
measures the Doppler shift in the frequency of ultrasound reflected and scattered from moving
tissues. This Doppler shift is proportional to the component of reflector or scatterer velocity
along the ultrasound beam. By looking for Doppler shifts in the received signal at specific times
after transmission (range-gating), the device can be used to determine the variation of tissue
velocity with distance along the ultrasound beam. The device is sensitive to movement only
within a region of the beam called the sample volume. The position of the sample volume along
the beam may be adjusted by altering the delay between transmission and range-gating. Multi-
channel devices have a number of sample volumes operating simultaneously.
The pulsed ultrasonic device is most commonly used to investigate blood flow when the
ultrasound is scattered from red blood cells.
This technical specification describes a range of tests which may be used to measure
performance and the test objects required. In many cases, the test method and test object
have been described in IEC 61206 and in these cases reference is simply made to this
document. Other tests and test objects are described in [1] and [2]. The test methods may be
considered as falling into one of the following three categories. The first is routine quality
control tests that can be carried out by a clinician or technologist to ensure that the system is
working adequately or has adequate sen
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