Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting

Published date

10-04-1995

Publisher

European Committee for Standards - Electrical

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Definitions
4 List of symbols
5 Configuration
6 Performance
   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
9 Preferred method for reporting performance of existing
   equipment
10 Specifications for labelling
11 Sampling
Annexes
A (informative) Choice of target and determination of target
                 plane-wave reflection loss
B (informative) Typical test equipment and test procedures
C (informative) Determination of the two-way insertion loss of
                 acoustic attenuators
D (informative) Rationale
E (informative) Bibliography
ZA (normative) Normative references to international
                 publications with their corresponding
                 European publications

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

Committee	CLC/SR 87
DocumentType	Standard
PublisherName	European Committee for Standards - Electrical
Status	Current

Standards	Relationship
NF EN 61266 : 1996	Identical
IEC 61266:1994	Identical
NBN EN 61266 : 1996	Identical
NEN 11266 : 1995	Identical
I.S. EN 61266:1997	Identical
PN EN 61266 : 2002	Identical
SN EN 61266 : 1995	Identical
BS EN 61266:1995	Identical
UNE-EN 61266:1996	Identical
CEI EN 61266 : 1998	Identical
DIN EN 61266:1996-06	Identical
IEC 61266:1994	Corresponds

EN 61102:1993/A1:1994	MEASUREMENT AND CHARACTERISATION OF ULTRASONIC FIELDS USING HYDROPHONES IN THE FREQUENCY RANGE 0.5 MHZ TO 15 MHZ
IEC 61161:2013	Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 61157:2007/A1:2013	STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT (IEC 61157:2007/A1:2013)
IEC TR 60854:1986	Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment
EN 61161:2013	Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 61101:1991	The absolute calibration of hydrophones using the planar scanning technique in the frequency range 0.5 MHz to 15 MHz
IEC 61157:2007+AMD1:2013 CSV	Standard means for the reporting of the acoustic output of medicaldiagnostic ultrasonic equipment
IEC 60866:1987	Characteristics and calibration of hydrophones for operation in the frequency range 0.5 MHz to 15 MHz
EN 61101:1993	The absolute calibration of hydrophones using the planar scanning technique in the frequency range 0,5 MHz to 15 MHz