EN IEC 80601-2-30 Medical Electrical Equipment, Part 2-30: Standard Test for Basic Safety of Automated Non-Invasive Blood Pressure Monitors

EUROLAB laboratory provides testing and compliance service within the scope of EN IEC 80601-2-30 standard. EN IEC 80601-2-30 applies to the basic safety and basic performance of automatic sphygmomanometers, hereinafter referred to as ME equipment, used through an inflatable cuff for the non-continuous indirect estimation of blood pressure without arterial puncture.

This standard specifies essential safety and essential performance requirements for this ME equipment and accessories, including requirements for the accuracy of a determination. This standard covers electrically powered automated ME equipment used for the intermittent, indirect estimation of blood pressure without arterial puncture. Including blood pressure monitors for the home healthcare environment.

Requirements for indirect estimation of blood pressure without display arterial puncture ME equipment with an electrically powered pressure transducer or with a stethoscope or other manual methods for determining blood pressure (non-automatic sphygmomanometers) are specified in the ISO 81060 standard.

Specific technical changes include:

• Identification of baseline performance, where the patient is the operator;
• New clinical accuracy requirements, additional mechanical strength requirements;
• Expanding coverage to include all automatic blood pressure monitors, including banning operator accessible 'Luer' connectors on the pneumatic system.

EUROLAB assists manufacturers with EN IEC 80601-2-30 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.