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I.S. EN 61266:1997

Current

Current

The latest, up-to-date edition.

ULTRASONICS - HAND-HELD PROBE DOPPLER FOETAL HEARTBEAT DETECTORS - PERFORMANCE REQUIREMENTS AND METHODS OF MEASUREMENT AND REPORTING

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-1997

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Applies 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.

DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
68
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
BS EN 61266:1995 Identical
NBN EN 61266 : 1996 Identical
SN EN 61266 : 1995 Identical
EN 61266:1995 Identical
UNE-EN 61266:1996 Identical
NF EN 61266 : 1996 Identical
DIN EN 61266:1996-06 Identical
IEC 61266:1994 Identical

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

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