Non-invasive sphygmomanometers - Clinical investigation of continuous automated measurement type
Non-invasive sphygmomanometers - Clinical investigation of continuous automated measurement type
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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
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...
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