BS EN 61266:1995

This standard BS EN 61266:1995 Ultrasonics. Hand-held probe Doppler foetal heartbeat detectors. Performance requirements and methods of measurement and reporting is classified in these ICS categories:

• 11.040.55 Diagnostic equipment

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.