EN 61266:1995
(Main)Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting
Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting
Is applicable to ultrasonic Doppler foetal heartbeat detectors which generate a single ultrasound beam and consist of a hand-held probe which is applied to the maternal abdomen to obtain information on foetal heart activity by means of the Doppler method using continuous wave (c.w) or quasi-continuous wave ultrasound. Establishes - methods of measurement of performances - requirements for the performance and the - reporting of performance
Ultraschall - Handgehaltene Doppler-Herzschlagdetektoren für Föten - Leistungsanforderungen sowie Meß- und Angabeverfahren
Ultrasons - Détecteurs des battements de coeur foetal à effet Doppler avec sonde à main - Prescriptions de performance et méthodes de mesure et de signalement
S'applique aux détecteurs ultrasonores des battements de coeur foetal par effet Doppler qui produisent un faisceau ultrasonore unique et qui consistent en une sonde à main appliquée sur l'abdomen maternel pour recueillir des informations sur l'activité du coeur foetal au moyen de la méthode Doppler utilisant des ultrasons à onde entretenue ou quasi-entretenue. Etablit: - des méthodes de mesure des performances - des prescriptions de performance et pour le signalement de ces performances
Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting (IEC 61266:1994)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2002
Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance
requirements and methods of measurement and reporting (IEC 61266:1994)
Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance
requirements and methods of measurement and reporting
Ultraschall - Handgehaltene Doppler-Herzschlagdetektoren für Föten -
Leistungsanforderungen sowie Meß- und Angabeverfahren
Ultrasons - Détecteurs des battements de coeur foetal à effet Doppler avec sonde à
main - Prescriptions de performance et méthodes de mesure et de signalement
Ta slovenski standard je istoveten z: EN 61266:1995
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
NORME CEI
IEC
INTERNATIONALE
INTERNATIONAL
Première édition
STANDARD
First edition
1994-12
Ultrasons –
Détecteurs des battements de coeur foetal
à effet Doppler avec sonde à main –
Prescriptions de performance et méthodes
de mesure et de signalement
Ultrasonics –
Hand-held probe Doppler foetal heartbeat
–
detectors
requirements and methods of
Performance
measurement and reporting
Droits de reproduction réservés — Copyright — all rights reserved
© CEI 1994
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microfilms, sans l'accord écrit de l'éditeur. in writing from the publisher.
les
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— 3 —
1266©IEC:1994
CONTENTS
Page
FOREWORD 5
INTRODUCTION 7
Clause
1 Scope 9
2 Normative references 9
3 Definitions
4 List of symbols 15
5 Configuration
rformance 6 Pe
6.1 Acoustic working frequency
7 Safety
8 Tests
8.1 Acoustic working frequency
8.2 Output power
8.3 Spatial-peak temporal-peak acoustic pressure
8.4 Effective area of the ultrasonic transducer active element
8.5 Overall sensitivity
rformance of existing equipment 25
9 Preferred method for reporting pe
10 Specifications for labelling 27
11 Sampling 29
Figures
Annexes
Choice of target and determination of target plane-wave reflection loss 35
A
B Typical test equipment and test procedures
Determination of the two-way insertion loss of acoustic attenuators C
D Rationale 59
E Bibliography
1266 ©IEC:1994 - 5 -
INTERNATIONAL ELECTROTECHNICAL COMMISSION
ULTRASONICS - HAND-HELD PROBE DOPPLER FOETAL
HEARTBEAT DETECTORS -
PERFORMANCE REQUIREMENTS AND METHODS OF
MEASUREMENT AND REPORTING
FOREWORD
The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
1)
comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to
promote international cooperation 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, prepared by technical committees on
which all the National Committees having a special interest therein are represented, express, as nearly as
possible, an international consensus of opinion on the subjects dealt with.
They have the form of recommendations for international use published in the form of standards, technical
3)
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.
International Standard IEC 1266 has been prepared by IEC technical committee 87:
Ultrasonics.
The text of this standard is based on the following documents:
Report on voting
DIS
87/71/RVD
87(CO)34
Full information on the voting for the approval of this standard can be found in the report
on voting indicated in the above table.
All annexes are for information only.
In this standard the following print types are used:
- Requirements proper: in roman type.
- Test specifications: in italic type.
– Notes: in smaller roman type.
- Words in bold in the text are defined in clause 3.
- 7 -
1266 ©IEC:1994
INTRODUCTION
Hand-held ultrasonic Doppler foetal heartbeat detectors are widely used for monitoring
2 MHz,
foetal heartbeat during pregnancy. They normally operate at frequencies of circa
and consist of an ultrasonic transducer acoustically coupled to the maternal abdomen and
associated electronics. A beam of ultrasound is directed by the operator to impinge on the
foetal heart and a small fraction of the incident ultrasound is reflected from the moving
aces of the heart. This ultrasound is subject to a frequency shift as a result of the
su rf
Doppler effect. It is then detected by a receiving transducer. Signal processing separates
the low-frequency signals associated with the foetal heartbeat from the high-frequency
ultrasonic oscillations and amplifies them for audio detection.
This International Standard, IEC 1266, specifies methods of evaluating the performance of
ultrasonic foetal heartbeat detectors and, in particular, specifies a method of determining
the sensitivity of the system to the detection of a moving target.
Foetal Doppler monitoring devices use a flat probe strapped to the patient and work on a
principle similar to that of hand-held foetal heartbeat detectors but are not covered by this
standard. The reason is that monitoring devices require a wide angle of view which is
often realised by using a multi-element transducer. This makes the method of operation of
foetal Doppler monitors much more complex than that of hand-held foetal heartbeat detec-
tors which use a narrow beam. Methods of assessment of performance would also be
more complex.
- 9 -
1266 ©IEC:1994
ULTRASONICS - HAND-HELD PROBE DOPPLER FOETAL
HEARTBEAT DETECTORS -
PERFORMANCE REQUIREMENTS AND METHODS OF
MEASUREMENT AND REPORTING
1 Scope
This International Standard IEC 1266 establishes:
- methods of measurement of performance of a complete ultrasonic hand-held Dop-
pler foetal heartbeat detector (hereinafter referred to as "equipment");
- equipment;
requirements for the performance of
- requirements for the reporting of the performance of existing equipment;
- requirements for the declaration by manufacturers in accompanying literature of
aspects of the performance of equipment.
This International Standard is applicable to ultrasonic Doppler foetal heartbeat detectors
which generate a single ultrasound beam and consist of a hand-held probe which is
applied to the maternal abdomen to obtain information on foetal heart activity by means of
the Doppler method using continuous wave (c.w.) or quasi-continuous wave ultrasound.
This standard, however, currently does not cover the continuous monitoring devices which
generate more than one ultrasound beam and are usually of the type utilising a similar
principle of operation but using a flat probe strapped to the patient.
This International Standard is not an equipment design standard.
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 601-1: 1988, Medical electrical equipment - Part 1: General requirements for safety
IEC 854: 1986,
Methods of measuring the performance of ultrasonic pulse-echo diagnostic
equipment
IEC 866: 1987, Characteristics and calibration of hydrophones for operation in the
frequency range 0,5 MHz to 15 MHz
IEC 1101: 1991, The absolute calibration of hydrophones using the planar scanning
technique in the frequency range 0,5 MHz to 15 MHz
- 11 -
1266 ©IEC:1994
IEC 1102: 1991, Measurement and characterisation of ultrasonic fields using hydrophones
in the frequency range of 0,5 MHz to 15 MHz
IEC 1157: 1992, Requirements for the declaration of the acoustic output of medical
diagnostic ultrasonic equipment
IEC 1161: 1992, Ultrasonic power measurement in liquids in the frequency range 0,5 MHz
to 25 MHz
3 Definitions
For the purposes of this International Standard, the following definitions apply:
3.1 acoustic coupling medium: Material placed between the probe and the body
ace in order to maintain acoustic transmission.
su rf
3.2 acoustic working frequency: Frequency of an acoustic signal based on the obser-
vation of the output of a hydrophone placed in an acoustic field.
For the purposes of this International standard, the signal is analysed using the
zero-crossing frequency technique, see IEC 854.
[3.4.1 of 1EC 1102].
3.3 continuous wave ultrasound: Ultrasonic oscillations which are either continuous or
quasi-continuous lasting for many tens of cycles.
3.4 Doppler frequency: Change in frequency of an ultrasound scattered wave caused
by relative motion between the scatterer and the probe. It is the difference frequency
between the transmitted and the received wave.
effective area of the ultrasonic transducer active element: -6 dB beam area at a
3.5
distance of 5 mm from the face of the probe.
[3.6 of IEC 1102].
Unit: millimetre squared, mm2
3.6 Doppler signal: Signal at the Doppler frequency.
3.7 equipment: Ultrasonic Doppler foetal heartbeat detector.
3.8 nominal acoustic working frequency: Value of the acoustic working frequency
quoted by the designer or manufacturer.
3.9 output power: Time-average ultrasonic power radiated by an ultrasonic transducer
into an approximately free field under specified conditions in a specified medium,
preferably in water.
[3.5 of IEC 1161].
Symbol: P
Unit: watt. W
- 13 -
1266 ©IEC:1994
3.10 overall sensitivity: Measure of the ability of an ultrasonic Doppler foetal heartbeat
detector to detect, above the noise level, a Doppler signal from a simulated point target
reflection loss, moving
(less than three wavelengths wide) of known target plane -wave
at a specified velocity and placed at a specified distance from the probe. The overall
sensitivity level,
S, in decibels (dB) is determined from:
S =A(d) +B+C
where
-wave reflection loss (dB) for the target at a distance d from
A(d) is the target plane
the probe;
B is the two-way attenuation over the acoustic pathway (dB), including that of the
acoustic attenuator(s), any coupling window and water path;
C is the signal-to-noise ratio (dB).
Symbol: S
Unit: decibel, dB
3.11 probe: An assembly, including the ultrasonic transducer element(s), which is
dedicated to the transmission and reception of ultrasound energy. It may also include
other components as necessary.
3.12 receiver unit: Part of the equipment which processes the ultrasonic signals from
the probe to produce at least a Doppler signal in the audible frequency range.
3.13 signal output part: Part of the equipment not being an applied part, intended to
deliver output signal voltages or currents to other equipment, for example, for display,
recording or data processing.
[2.1.19 of IEC 601-1].
is usually a terminal
NOTE - For an ultrasonic Doppler foetal heartbeat detector, the signal output part
receiver unit which allows connection of an earphone, headphone,
or connector at the output of the
speaker or other audio equipment.
3.14 spatial-peak temporal-peak acoustic pressure: Larger of the maximum positive
or modulus of the maximum negative instantaneous acoustic pressure in an acoustic field.
[3.26, 3.27 and 3.50 of IEC 1102].
Unit: pascal, Pa
3.15 target plane-wave reflection loss: Ratio (dB) of the acoustic pressure at a
specified distance from a target, in the ultrasonic field 180° back-reflected from the target,
to the acoustic pressure in the plane wave incident coaxially with the target axis of sym-
metry and at the position of the target if the target were removed.
Target plane-wave reflection loss is expressed as a positive number.
Symbol: A
Unit: decibel, dB
- 15 -
1266 © IEC:1994
which generates a high-frequency
transmitter unit: Part of the equipment
3.16
probe.
continuous wave or quasi-continuous wave electrical signal for energising the
4 List of symbols
a = radius of a ball or rod target
A(d) = target plane-wave reflection loss (dB) at a distance d
B = two-way attenuation (dB) over a total acoustic path
= two-way insertion loss (dB) of an acoustic attenua
...
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