EUROLAB laboratory provides testing and compliance services within the scope of EN 1060-4 standard. This standard describes investigative testing procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers designed for indirect measurement of blood pressure.
Identified auscultatory blood pressure measurements should be made by two observers through a pair of stethoscopes. The auscultatory reference value will then be the average of the two values determined by the observers.
The difference between both values should not exceed 4 mmHg. Measurements with an observer-to-observer difference greater than 4 mmHg will not be included in the data set. The number of discarded measurements should not exceed the number of valid measurements required.
Calibrated reference manometers must meet the requirements of EN 1060-1 to EN 1060-3, but must not exceed 1 mmHg (0,1 kPa) error limits with falling cuff pressure before the start of the clinical trial.
The selection of subjects and their numbers depends on the intended use of the device to be tested (in accordance with the information given in the instructions for use or the instructions on the device).
EUROLAB assists manufacturers with EN 1060-4 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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