AAMI 81060-1

Description / Abstract: This part of ISO 81060 specifies requirements for non-automated sphygmomanometers, as defined in 3.11, and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.

This part of ISO 81060 specifies requirements for the safety and essential performance, including effectiveness and labeling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement.

The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.

EXAMPLE 1 A stethoscope for detecting Korotkoff sounds, Doppler ultrasound or other manual methods.

Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressure sensing elements and/or displays used in conjunction with other automatic methods determining blood pressure are specified in IEC 60601-2-30.

Requirements for invasive blood pressure measurement equipment that directly measure blood pressure are specified in document IEC 60601-2-34.

EXAMPLE 2 Measuring equipment, including associated transducers, that is used for the invasive measurement of circulatory system pressures.