1 Scope
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.