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IEC 60601-2-30 Automated Non-Invasive Sphygmomanometers Testing

Medical electrical equipment – Part 2-30: the basic safety and essential performance of automated non-invasive sphygmomanometers

IEC 60601-2-30 Scope:

IEC 60601 2 30 and EN 60601 2 30 applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as medical electronic equipment, which by means of an inflatable cuff, are used for intermittent non-continuous indirect measurement of the blood pressure without arterial puncture.

NOTE 1 Equipment that performs indirect measurement of the blood pressure without arterial puncture does not directly measure the blood pressure. It only estimates the blood pressure.

IEC 60601-2-30 testing specifies requirements for the basic safety and essential performance for this medical electronic equipment and its accessories, including the requirements for the accuracy of a determination.

EN 60601-2-30 covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, medical electronic equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment.

Requirements for indirect measurement of the blood pressure without arterial puncture medical electronic equipment with an electrically-powered pressure transducer and/or displays used in conjunction with a stethoscope or other manual methods for determining blood pressure (non-automated sphygmomanometers) are specified in document ISO 81060-1.

Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in IEC 60601-2-30 except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1.

Keystone Compliance assists manufacturers with IEC 60601-2-30 and EN 60601-2-30 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-30 test lab needs.