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BS EN 61266:1995

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

15-10-1995

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 temoral-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
Figures
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 detectors which generate a single continuous wave or quasi-continuous wave ultrasonic beam. It does not cover continuous monitoring devices which generate more than one ultrasound beam and use a flat standard probe strapped to a patient. This standard is not an equipment design standard.

This International Standard IEC1266 establishes:

  • methods of measurement of performance of a complete ultrasonic hand-held Doppler foetal heartbeat detector (hereinafter referred to as “equipment??);

  • requirements for the performance of equipment;

  • 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.

Committee
EPL/87
DevelopmentNote
Supersedes 91/22890 DC. Also numbered as IEC 61266. (09/2005)
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
UNE-EN 61266:1996 Identical
NF EN 61266 : 1996 Identical
DIN EN 61266:1996-06 Identical
EN 61266:1995 Identical
NBN EN 61266 : 1996 Identical
I.S. EN 61266:1997 Identical
SN EN 61266 : 1995 Identical

BS 7041:1989 Specification for characteristics and calibration of hydrophones for operation in the frequency range 0.5 MHz to 15 MHz
BS EN 61161:2013 Ultrasonics. Power measurement. Radiation force balances and performance requirements
BS EN 61101:1994 Specification for absolute calibration of hydrophones using the planar scanning technique in the frequency range 0,5 MHz to 15 MHz
BS 5724-1(1989) : 1989 AMD 6715 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY
IEC TR 60854:1986 Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment
BS EN 61102:1994 Specification for measurement and characterisation of ultrasonic fields using hydrophones in the frequency range 0.5 MHz to 15 MHz
BS EN 61157 : 2007 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT

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