BS EN ISO 81060-3:2022

1   Scope This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period . A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure , diastolic blood pressure or mean arterial pressure ) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer . This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation . Representation of output is not covered by this document.

NOTE 1

IEC 62366‑1

provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concern...