This International Standard IEC1266 establishes:
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methods of measurement of performance of a complete ultrasonic hand-held Doppler foetal heartbeat detector (hereinafter referred to as “equipment??);
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requirements for the performance of equipment;
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requirements for the reporting of the performance of existing equipment;
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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.