EN 1060-3 Non-Invasive Blood Pressure Monitors, Part 3: Supplementary Requirements for Electro-Mechanical Blood Pressure Measurement Systems

Medical Device Tests

EN 1060-3 Non-Invasive Blood Pressure Monitors, Part 3: Supplementary Requirements for Electro-Mechanical Blood Pressure Measurement Systems

EUROLAB laboratory provides testing and compliance services within the scope of EN 1060-3 standard. This part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measurement systems used through an inflatable cuff for non-invasive measurements of arterial blood pressure in the upper arm, wrist and thigh. It also specifies requirements for its accessories and gives test methods.

EN 1060-3 Non-Invasive Blood Pressure Monitors, Part 3: Supplementary Requirements for Electro-Mechanical Blood Pressure Measurement Systems

This part of EN 1060 applies to electro-mechanical blood pressure measurement systems where cuff pressure is measured electronically, but blood pressure can be determined manually or automatically with the aid of a stethoscope.

Additional safety requirements for automatic loop indirect blood pressure monitoring equipment are specified in EN 60601-2-30.

Equipment or parts thereof that use materials or forms of construction other than those described in this part of EN 1060 will be accepted if an equivalent degree of safety and performance can be demonstrated.

The nominal range for cuff pressure measurement should be specified by the manufacturer. The measuring and gauge ranges of the cuff pressure must be equal to the nominal range. Values ​​of blood pressure measurement results outside the nominal range of the cuff pressure should be clearly stated as out of range.

EUROLAB assists manufacturers with EN 1060-3 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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