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Ultrasonics. Hand-held probe Doppler foetal heartbeat detectors. Performance requirements and methods of measurement and reporting
This International Standard IEC 1266 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.
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.
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