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 concerns absolute
accurate values or trending values.
The requirements and methods for the clinical investigation of
continuous
automated non-invasive sphygmomanometers provided
in this document are applicable to any subject population, and any condition of use
of the continuous
automated non-invasive sphygmomanometers.
NOTE 2 Subject populations can, for example, be represented by age or weight ranges.
NOTE 3 This document does not provide a method to assess the effect of artefacts during
the clinical investigation (e.g. motion artefacts induced by
the movement of the subject or the movement of the platform supporting the
subject).
This document specifies additional disclosure requirements for the
accompanying documents of continuous automated non-invasive
sphygmomanometers that have undergone
clinical investigation according to this document.
This document is not applicable to:
-
— the clinical investigation of a non-automated
sphygmomanometer as given in ISO 81060‑1,
-
— the clinical investigation of an intermittent automated
non-invasive sphygmomanometer as given in
ISO 81060‑2,
-
— an automated non-invasive sphygmomanometer as given in IEC 80601‑2‑30,
or
-
—
invasive blood pressure monitoring equipment as given in
IEC 60601‑2‑34.