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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

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.


Dates of withdrawal of national standards are available from NSAI.

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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