BS EN 61266:1995

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.