EN 61266 Ultrasonic, Handheld Probe Doppler Fetal Heartbeat Detectors, Performance Requirements and Methods of Measurement and Reporting

Medical Device Tests

EN 61266 Ultrasonic, Handheld Probe Doppler Fetal Heartbeat Detectors, Performance Requirements and Methods of Measurement and Reporting

EUROLAB laboratory provides testing and compliance services within the scope of EN 61266 standard. It can be applied to ultrasonic Doppler fetal heartbeat detectors, which consist of a handpiece that produces a single ultrasound beam and is applied to the womb to obtain information about fetal heart activity by the Doppler method using either continuous wave (cw) or half.

EN 61266 Ultrasonic, Handheld Probe Doppler Fetal Heartbeat Detectors, Performance Requirements and Methods of Measurement and Reporting

It determines performance measurement methods, performance requirements and performance reporting. However, this standard does not currently cover continuous monitoring devices of the type that generate more than one ultrasound beam and generally use a similar principle of operation, but using a flat probe strapped to the patient.

Fetal Doppler monitors use a flat probe attached to the patient and operate on a similar principle to hand-held fetal heartbeat detectors, but are not covered by this standard. This is because tracking devices require a wide viewing angle, which is often accomplished using a multi-element converter.

This makes the way fetal Doppler monitors work much more complicated than hand-held fetal heartbeat detectors that use a narrow beam. Performance appraisal methods will also be more complex.

EUROLAB assists manufacturers with EN 61266 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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